Ex Parte Eifler et al

Patent Trial and Appeal Board

Aug 22, 2016

13968580 (P.T.A.B. Aug. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/968,580 08/16/2013
13897 7590 08/24/2016
Abel Law Group, LLP
8911 N. Capital of Texas Hwy
Bldg 4, Suite 4200
Austin, TX 78759
FIRST NAMED INVENTOR
Martin EIFLER
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.
6580-P50086 1487
EXAMINER
LEE, DANIEL H.
ART UNIT PAPER NUMBER
1746
NOTIFICATION DATE DELIVERY MODE
08/24/2016 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):
mail@Abel-IP.com
hmuensterer@abel-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MAR TIN EIFLER,
MARTIN BECHTEL, ARNOLD FRERICHS, MATTHIAS PULLA,
HENRY HAHN, and JOACHIM GARDEIN
Appeal2014-009786
Application 13/968,580
Technology Center 1700
Before ADRIENE LEPIANE HANLON, GEORGE C. BEST, and
JULIA HEANEY, Administrative Patent Judges.
HANLON, Administrative Patent Judge.
DECISION ON APPEAL
A. STATEMENT OF THE CASE
The Appellants filed an appeal under 35 U.S.C. § 134 from an Examiner's
decision finally rejecting claims 25-28 and 30-48. Claim 29 is also pending but
has been withdrawn from consideration. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM-IN-PART.
Appeal2014-009786
Application 13/968,580
Claims 25 and 38, the independent claims on appeal, are reproduced below
from the Claims Appendix of the Appeal Brief dated June 10, 2014 ("App. Br.").
25. A method of producing a patient interface for resting on an
outer surface of a patient's body and containing a gel filling, wherein
a gel covering formed from a flexible material has a cavity at least in
some areas thereof and has at least one dedicated opening through
which the cavity is filled with gel in liquid form, which thereafter
cures in the gel covering.
App. Br. 25.
38. A method of producing a sealed covering for a patient interface
for resting on an outer surface of a patient's body, wherein a covering
blank is sealed by a stopper and a permanent connection between the
covering blank and the stopper is produced by the use of a joining
element, and wherein the sealed covering is produced from a uniform
material.
App. Br. 26.
The claims on appeal stand rejected as follows:
(1) claims 25, 28, 33, and 45--48 under 35 U.S.C. § 102(b) as anticipated
by Schulz et al.; 1
(2) claims 25, 26, 28, and 33-37 under 35 U.S.C. § 103(a) as
unpatentable over McGhan et al. 2 in view of Schulz;
(3) claim 27 under 35 U.S.C. § 103(a) as unpatentable over McGhan in
view of Schulz, and further in view of Herzfeld; 3
(4) claim 31under35 U.S.C. § 103(a) as unpatentable over McGhan in
view of Schulz, and further in view of V askys et al.; 4
1 US 5,370,688, issued December 6, 1994 ("Schulz").
2 US 3,852,832, issued December 10, 1974 ("McGhan").
3 US 3,942,423, issued March 9, 1976 ("Herzfeld").
4 US 4,086,666, issued May 2, 1978 ("Vaskys").
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(5) claim 32 under 35 U.S.C. § 103(a) as unpatentable over McGhan in
view of Schulz, and further in view of Sado; 5
(6) claims 30 and 38--41 under 35 U.S.C. § 103(a) as unpatentable over
McGhan in view of Schulz, and further in view of Vaskys and Herzfeld; and
(7) claims 42--44 under 35 U.S.C. § 103(a) as unpatentable over McGhan
in view of Schulz, and further in view of Van Aken Redinger et al. 6
B. DISCUSSION
1. Rejection (1)
a. Claims 25, 28, 33, and 48
There is no dispute on this record that Schulz, which discloses a method of
making a breast prosthesis, describes all of the steps recited in claim 25. The
dispute as to claim 25 involves the preamble, i.e., "a patient interface for resting on
an outer surface of a patient's body." App. Br. 25. The Appellants do not direct us
to any definition of "patient interface" that excludes the breast prosthesis of
Schulz. Rather, the Appellants argue that:
[T]he flexible material for making the gel covering must be of a type
and a quality (in terms of impurities contained therein) which is
suitable for contact with the outer surface (skin) of a patient's body
(e.g., not causing skin allergies or any other problems related to
incompatibility with skin), that the size and the shape of the gel
covering are limited to sizes and shapes which can reasonably be
considered to be suitable for resting on an outer surface of a patient's
body, and that the cured gel filling must be a material that will not
cause any health hazards if it were to come into contact with an outer
surface of the patient's body (e.g., due to accidental rupture of the gel
covering).
App. Br. 12 (emphasis added).
5 US 3,715,047, issued February 6, 1973 ("Sado").
6 US 4,455,691, issued June 26, 1984 ("Redinger").
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Application 13/968,580
Significantly, the Appellants do not direct us to any evidence or provide any
technical reasoning showing that the breast prosthesis disclosed in Schulz does not
satisfy those requirements. Schulz expressly discloses that "the inner skin 24 [of
the breast prosthesis] is placed adjacent to the user's body." Schulz, col. 3, 11. 14-
15 (emphasis added). Thus, one of ordinary skill in the art would have understood
that the breast prosthesis described in Schulz is suitable for contacting an outer
surface of a patient's body as recited in claim 25. See Ans. 7.7
On this record, the Appellants have failed to show that the preamble of claim
25 distinguishes the claimed invention from the breast prosthesis described in
Schulz. Therefore, the § 102(b) rejection of claim 25 is sustained.
The Appellants do not present arguments in support of the separate
patentability of claims 28, 33, and 48. Therefore, the§ 102(b) rejection of claims
28, 33, and 48 is also sustained.
b. Claims 45--47
Claims 45--4 7 depend from claim 25 and recite that the patient interface is
for use with a nasal pillow, a face mask, and an oral mask, respectively. App. Br.
27.
The Appellants argue that "neither the size nor the shape of an encapsulated
breast prosthesis ... as disclosed by SCHULZ can reasonably be considered to be
suitable for use in combination with a nasal pillow, a face mask or an oral mask."
App. Br. 13.
The Examiner responds as follows:
As to the dependent claims which recite that the patient interface is
suitable for use with a nasal pillow, a face mask, or an oral mask,
these claims are considered to be very broad. These limitations would
7 Examiner's Answer dated August 1, 2014.
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Application 13/968,580
also be met by the teachings of Schulz ... as the product produced in
the method of Schulz is suitable for use with the claimed uses (e.g.
during surgery). In other words, the breast prosthesis can be used and
a face mask can be used separately during surgery, and the limitations
of the claim[ s] would be met.
Ans. 7-8 (emphasis added).
The Appellants argue that the Examiner's interpretation of claims 45--4 7 is
unreasonably broad. According to the Appellants, "there is no indication
whatsoever in the instant specification which would support the Examiner's
interpretation. "8 Reply Br. 3 (emphasis omitted). 9 The Appellants' argument is
supported by the record. See, e.g., Spec. 21, 1. 6 (gel pads 26 are embedded in the
nasal pillows 25); Spec. 11, 11. 10-11 (wall 6 of gel covering 3 serves to connect it
with the mask body). Therefore, the § 102(b) rejection of claims 45--4 7 is not
sustained.
2. Rejections (2}--(7)
a. Claims 25, 26, 28, 33, 42, and 44
The Examiner finds McGhan discloses a prosthesis comprising a fluid-
impermeable envelope filled with silicone gel. Ans. 3 (citing McGhan, col. 2, 11.
29-38); see also McGhan, col. 1, 11. 2-5 ("invention relates to ... prostheses which
are used to fill a cavity left by the removal of a portion of the anatomy or to
reshape an existing contour, such as by enlargement of a female breast"). The
Examiner finds McGhan does not expressly teach that the gel is cured. The
8 During prosecution, "the PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by the
written description contained in the applicant's specification." In re Morris, 127
F.3d 1048, 1054--55 (Fed. Cir. 1997).
9 Reply Brief dated September 12, 2014.
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Examiner, however, relies on Schulz to show that "it was well known and
conventional at the time of the invention that prostheses were cured to a gelatinous
state." Ans. 3 (citing Schulz, col. 1, 11. 11-12).
The Appellants argue that "the firmness of the filling [in McGhan] is
adjusted by the amount of injected filling material (i.e., the filling pressure), not by
a subsequent curing operation of the filling material." App. Br. 16 (emphasis
omitted). Therefore, the Appellants "disagree with the Examiner that it would
have been obvious to one of ordinary skill in the art to cure the filling material of
the prosthesis ofMcGHAN." App. Br. 16 (emphasis omitted).
The Appellants' argument is not persuasive of reversible error. McGhan
discloses that the fluid material used to fill the prosthesis "may be saline solution
or a silicone gel." McGhan, col. 2, 11. 33-34 (emphasis added). It is unclear on
this record why McGhan's disclosure that "fluid is injected into the prosthesis in
the amount needed to give it the desired firmness" (McGhan, col. 2, 11. 36-37)
would have discouraged one of ordinary skill in the art from curing the injected
silicone gel to achieve its final properties.
The Appellants also argue that McGhan is non-analogous art because "the
implant of McGHAN has virtually nothing in common with a patient interface (has
to satisfy completely different requirements), let alone a patient interface for
resting on an outer surface of a patient's body." App. Br. 14 (emphasis omitted).
The Appellants argue that the disclosure of McGhan relates to a fixation means for
holding a prosthesis in place after implantation. According to the Appellants "a
corresponding problem does not occur in the case of a patient interface that does
not come into contact with the inside of the human body and does not have to be
held in place naturally." App. Br. 15.
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As stated in Jn re Wood, 599 F.2d 1032, 1036 (CCPA 1979):
The determination that a reference is from a nonanalogous art is
... two-fold. First, we decide if the reference is within the field of the
inventor's endeavor. If it is not, we proceed to determine whether the
reference is reasonably pertinent to the particular problem with which
the invention was involved.
"A reference is reasonably pertinent if, even though it may be in a different field
from that of the inventor's endeavor, it is one which, because of the matter with
which it deals, logically would have commended itself to an inventor's attention"
in considering the inventor's problem. In re Clay, 966 F.2d 656, 659 (Fed. Cir.
1992).
On appeal, the Appellants neither define the field of their endeavor nor
identify the particular problem with which their invention was involved. To the
extent that the Appellants' field of endeavor can be considered "patient interfaces,"
the Examiner appears to find that the breast prosthesis disclosed in McGhan falls
within the broad scope of "patient interfaces." The Appellants do not direct us to
any evidence establishing otherwise. 10
For the reasons set forth above, the § 103(a) rejection of claim 25 is
sustained.
The Appellants do not present arguments in support of the separate
patentability of any of claims 26, 28, 33, 42, and 44, which depend from claim 25.
10 As for the second prong of the Wood test, the Appellants disclose that "the
objective of the present invention is to improve the comfort of wearing a patient
interface." Spec. 2, 11. 2-3. That objective is said to be achieved "wherein the gel
covering has a cavity that is filled with a gel of a certain consistency and
elasticity." Spec. 2, 11. 8-10. Clearly, comfort is also a concern in designing breast
prostheses.
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Therefore, the§ 103(a) rejections of claims 26, 28, 33, 42, and 44 are sustained for
the reasons set forth above sustaining the§ 103(a) rejection of claim 25.
b. Claims 34 and 35
Claim 34 depends from claim 33 and recites "wherein the silicone gel has a
silicone oil fraction of less than 20%." Claim 35 depends from claim 33 and
recites "wherein the silicone gel contains no silicone oil." App. Br. 26.
The Examiner finds "McGhan makes no mention of the addition of any
silicone oil in the silicone gel." Ans. 3. Therefore, the Examiner "presume[s] that
the silicone gel of McGhan does not contain any silicone oil." Ans. 3; see also
Ans. 8 ("absent any mention of adding silicone oil or any evidence to the contrary,
there would be a reasonable expectation that no silicone oil would be present").
The Appellants argue:
[I]t is pointed out that there is a difference between an absence of
disclosure ... and an affirmative statement regarding the maximum
fraction of silicone oil that may be present in the silicone gel of
ivicGHAN. Since ivicGHAN does not provide any information in this
regard, McGHAN provides no apparent reason for one of ordinary
skill in the art to exclude silicone gels that contain a significant
amount of silicone oil.
App. Br. 17 (emphasis omitted).
McGhan's broad disclosure that the filler material may be silicone gel does
not evince that the silicone gel is more likely than not to be free of silicon oil.
Therefore, a preponderance of the evidence does not support the Examiner's
finding that the silicone gel in McGhan does not contain silicone oil. See Black's
Law Dictionary 1064 (5th ed. 1979) ("preponderance of evidence" is defined as
"evidence which as a whole shows that the fact sought to be proved is more
probable than not"); In re Oetiker, 977 F.2d 1443, 1449 (Fed. Cir. 1992) ("factual
determinations by the PTO must be based on a preponderance of the evidence").
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The Examiner has also failed to explain why it would have been obvious to one of
ordinary skill in the art, based on the teachings of McGhan, to use a silicone gel
having no silicone oil in the disclosed breast prosthesis. For these reasons, the
§ 103(a) rejection of claims 34 and 35 is not sustained.
c. Claims 36 and 37
Claim 36 depends from claim 25 and recites "wherein the cured gel has a
hardness, at least in some areas, of from about 10 Shore 00 to about 30 Shore
00." Claim 37 depends from claim 25 and recites "wherein the cured gel has a
hardness, at least in some areas, of from about 12 Shore 00 to about 20 Shore
00." App. Br. 26.
The Examiner finds that "McGhan as evidenced in Schulz teach silicone gel
that is cured for the purpose of simulating human tissue in a prosthesis." Ans. 4.
Therefore, the Examiner concludes that "it would be expected that the hardness of
the silicone gel of McGhan as evidenced by Schulz would fall within the same
range as claimed by Applicant." Ans. 4.
Significantly, the Examiner has failed to explain, in any detail, why the
silicone gel in McGhan's modified breast prosthesis, cured to simulate human
tissue, would have been expected to have a hardness, at least in some areas, within
the ranges recited in claims 36 and 37. See App. Br. 18. For this reason, the
§ 103(a) rejection of claims 36 and 37 is not sustained.
d. Claims 27, 30, and 38--41
The Examiner does not find that McGhan, as evidenced by Schulz, discloses
using an adhesive or an otherwise permanent connection to join the covering and
the stopper of McGhan's prosthesis as recited in claims 27, 30, and 38. Ans. 4, 6.
The Examiner finds Herzfeld teaches "applying a silicone rubber adhesive to
a rod that is contacted to a stopper so that the stopped [sic, stopper] will be
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securely bonded to the rod." Ans. 4 (citing Herzfeld, col. 2, 1. 1-15); see also
Ans. 6. Thus, the Examiner concludes that it would have been obvious to use the
adhesive of Herzfeld to join the gel covering and the stopper of McGhan to prevent
the silicone gel from escaping. Ans. 4.
The Appellants argue that Herzfeld relates to a device for aging wine.
According to the Appellants, "[i]t is not seen that someone interested in modifying
the method of making the implants of McGHAN would expect to find any useful
information in this regard in a document that relates to a device for aging wine."
App. Br. 19.
The Appellants' argument is persuasive of reversible error. See, e.g.,
Herzfeld, col. 1, 11. 60-64 and col. 2, 11. 9-11 (sealant means for sealing the
exterior surface of an elongated wooden rod is provided adjacent one end of the
rod and a stopper is applied to that end of the rod before the sealant means is
cured). Therefore, the§ 103(a) rejections of claims 27, 30, and 38 are not
sustained.
Claims 39--41 depend from claim 38. Therefore, the§ 103(a) rejection of
claims 39--41 also is not sustained.
e. Claim 31
Claim 31 depends from claim 25 and recites "wherein the gel covering is
made of silicone." App. Br. 25.
The Examiner relies on Vaskys to show that it would have been obvious to
one of ordinary skill in the art to use silicone rubber as the gel covering in the
breast prosthesis ofMcGhan. Ans. 5.
The Appellants argue that one of ordinary skill in the art would not have
combined the teachings of McGhan and Vaskys as proposed by the Examiner
because "the prosthesis of McGHAN is to be implanted into the human body
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whereas the prosthesis of V ASKYS is to be attached to the outside of the human
body." App. Br. 20 (emphasis omitted).
The Appellants' argument is not persuasive of reversible error. McGhan
expressly discloses that silicone elastomer is suitable for use in an implantable
breast prosthesis. See McGhan, col. 2, 11. 52---61. Therefore, the§ 103(a) rejection
of claim 31 is sustained.
f. Claim 32
Claim 32 depends from claim 26 and recites "wherein the stopper is made of
silicone." App. Br. 25.
The Examiner finds the combined teachings of McGhan and Schulz do not
teach that McGhan's stopper is made of silicone. Nonetheless, the Examiner relies
on Sado to show that "stoppers made of silicone are able to obtain a close fit and
are extremely stable to heat." Ans. 5 (citing Sado, col. 1, 11. 20-31 ). The
Examiner concludes that it would have been obvious to one of ordinary skill in the
art to use a silicon stopper in ivicGhan's prosthesis "as it would provide a close fit
and be stable to heat." Ans. 5.
The Appellants argue that one of ordinary skill in the art would not have
combined the teachings of McGhan and Sado as proposed by the Examiner
because "SADO relates to plugs to be fixed into the mouths of vessels used for
culturing microbes or for rearing animals in a germ free environment." App. Br.
21 (emphasis omitted).
The Appellants' argument is not persuasive of reversible error. Sado
discloses plugs comprised of silicone rubber. Sado discloses that silicone rubber is
extremely stable to heat which enables the plugs to be sterilized at a high
temperature. Sado, col. 1, 11. 27-32. Clearly, one of ordinary skill in the art would
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have considered the plugs disclosed in Sado to be useful in the sterile environment
of Mc Ghan' s implantable breast prosthesis.
The§ 103(a) rejection of claim 32 is sustained.
g. Claim 43
Claim 43, which depends from claim 25, recites "wherein the gel covering
has a wall thickness, at least in some areas, of about 0.5 mm." App. Br. 27. The
Appellants argue that the disclosure of between 0.05 mm and about 0.2 mm in
Redinger11 does not render obvious a wall thickness of about 0.5 mm and the
Examiner has not offered any explanation in this regard. App. Br. 23.
The Appellants' argument is persuasive of reversible error. Therefore, the
§ 103(a) rejection of claim 43 is not sustained.
C. DECISION
The Examiner's decision rejecting claims 25, 28, 33, and 48 under 35 U.S.C.
§ 102(b) as anticipated by Schulz is affirmed.
The Examiner's decision rejecting claims 45--47 under 35 U.S.C. § 102(b) as
anticipated by Schulz is reversed.
The Examiner's decision rejecting claims 25, 26, 28, and 33 under 35 U.S.C.
§ 103(a) as unpatentable over McGhan in view of Schulz is affirmed.
The Examiner's decision rejecting claims 34--37 under 35 U.S.C. § 103(a) as
unpatentable over McGhan in view of Schulz is reversed.
The Examiner's decision rejecting claim 27 under 35 U.S.C. § 103(a) as
unpatentable over McGhan in view of Schulz, and further in view of Herzfeld is
reversed.
11 See Ans. 7 (finding Redinger discloses that the thickness of the sac is between
0.05 mm and about 0.2 mm (citing Redinger, col. 2, 11. 27-28)).
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The Examiner's decision rejecting claim 31 under 35 U.S.C. § 103(a) as
unpatentable over McGhan in view of Schulz, and further in view of Vaskys is
affirmed.
The Examiner's decision rejecting claim 32 under 35 U.S.C. § 103(a) as
unpatentable over McGhan in view of Schulz, and further in view of Sado is
affirmed.
The Examiner's decision rejecting claims 30 and 38--41 under 35 U.S.C.
§ 103(a) as unpatentable over McGhan in view of Schulz, and further in view of
V askys and Herzfeld is reversed.
The Examiner's decision rejecting claims 42 and 44 under 35 U.S.C.
§ 103(a) as unpatentable over McGhan in view of Schulz, and further in view of
Redinger is affirmed.
The Examiner's decision rejecting claim 43 under 35 U.S.C. § 103(a) as
unpatentable over McGhan in view of Schulz, and further in view of Redinger is
reversed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED-IN-PART
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