Ex Parte JOHNSON et al

Patent Trial and Appeal Board

Nov 16, 2018

13798818 (P.T.A.B. Nov. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/798,818 03/13/2013
27777 7590 11/20/2018
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
KIRK JOHNSON
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.
COD5267USCIP2 6852
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
11/20/2018 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pairjnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIRK JOHNSON, JUAN A. LORENZO, and
ROBERTSLAZAS
Appeal2017-004379
Application 13/798,818
Technology Center 3700
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134 involving
claims to an occlusive device for endovascular treatment of an aneurysm and
a method related to use of such a device. The Examiner rejected the claims
as indefinite, anticipated, and obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE. A New Ground of Rejection is, however, entered on
claims 1 and 16 for obviousness.
1 Appellants identify the Real Party in Interest as DePuy Synthes Products,
Inc. Br. 1.
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Application 13/798,818
STATEMENT OF THE CASE
As background, the Specification explains that a "significant
challenge for many current neck-occlusive techniques is to substantially
block the aneurysm neck in the parent vessel and yet not impede flow into
perforator-type blood vessels, also referred to as small branch vessels." Id.
,r 8. Unintentional blockage of such perforator vessels can cause ischemia
and severe damage to the patient. Id.
Appellants' "invention relates to implants within body vessels and
more particularly to occlusive devices including stents which are irreversibly
modified based on localized pressure differentials." Spec. ,r 2. More
specifically, the Specification explains that
[ t ]his invention results from the realization that the neck
of an aneurysm in a parent vessel can be occluded without also
occluding nearby vessels, such as perforator vessels,
communicating with the parent vessel by providing a device
having frangible material, associated with pores, which
irreversibly erodes or ruptures, including deforming,
substantially only based on differential pressure and penetrating
fluid flow into the perforator vessels. The device effectively
senses the presence of an ostium of a perforator vessel and
modifies itself to permit flow into the ostium through one or
more of the pores, thereby minimizing ischemia, while
continuing to substantially block flow into the aneurysm.
Id. ,r 16; see also id. at Fig. 1 (depicting a tubular, stent-like device (10)
disposed).
Claims 1-8, 10-20, and 22-26 are on appeal. Claim 1 is illustrative
and is reproduced below:
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1. An occlusive device suitable for endovascular treatment of
an aneurysm in a region of a parent vessel in a patient,
compnsmg:
a structure having pre-established pore features and having
dimensions suitable for insertion into vasculature of the patient
to reach the region of the aneurysm in the parent vessel; and
a frangible material associated with the pore features to
generate a first condition for the pore features which initially
provides a substantial barrier to flow through the frangible
material and, for at least a majority of the pore features, is
capable of at least one of localized rupturing and localized
eroding, in the presence of a localized pressure differential
arising at an ostium of a perforator vessel communicating with
the parent vessel to generate, within an acute time period, a
second condition for pore features experiencing the localized
pressure differential to minimize ischemia downstream of the
perforator vessel, the frangible material remaining intact in the
presence of a net-zero pressure differential arising at an
aneurysm of a vessel, the frangible material includes a non-
biodegradable portion and a biodegradable portion.
Br. 8 (Claims App.).
Claim 16 recites a method of treating an aneurysm by selecting,
inserting, and positioning the occlusive device having the features
substantially as recited in claim 1. Br. 9--10.
The claims stand rejected2 as follows:
2 The Examiner also provisionally rejected the claims for statutory double
patenting under § 101 for claiming the same invention. Final Act. 3---6. In
the Answer, however, the Examiner indicates that the double patenting
rejection "is withdrawn in response to the Terminal Disclaimer." Ans. 2.
As a threshold matter, a terminal disclaimer does not overcome a statutory,
same invention double patenting rejection. MPEP § 804. Nevertheless,
because the application (U.S. Appl. No. 13/076,474) is now abandoned, the
provisional double patenting rejection is moot.
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Application 13/798,818
I. Claims 1-8, 10-20, and 22-26 under 35 U.S.C. § 112, second
paragraph, as indefinite.
II. Claims 1--4, 6, 8, 14--18, and 24--26 under 35 U.S.C. § I02(b)
as anticipated by Molaei. 3
III. Claims 5, 7, 19, and 20 under 35 U.S.C. § I03(a) as obvious
over Molaei.
IV. Claims 10-13, 22, and 23 under 35 U.S.C. § I03(a) as obvious
over Molaei and Boismier. 4
Appellants indicate that they are aware of no related appeals. Br. 2.
The Board, however, notes related Appeal No. 2016-003831 (U.S. Appl.
13/076,474 ("the '474 Application")), which was pending at the time this
appeal was filed. The Specification states that the present application claims
priority to the '4 7 4 Application and that it is incorporated by reference in its
entirety. Spec. ,r 1. The Board has since decided this other appeal, affirming
the rejections for obviousness and double patenting. In re Slazas, No. 2016-
003831 (PTAB Aug. 10, 2017). 5
INDEFINITENESS
The Examiner rejected all the claims on appeal for indefiniteness.
Final Act. 7. According to the Examiner, the claim language is amenable to
two plausible constructions and, therefore, "the metes and bounds of the
3 Molaei et al., US 2006/0259131 Al, published Nov. 16, 2006.
4 Boismier et al., US 2008/0071348 Al, published Mar. 20, 2008.
5 The claims in the related appeal appear to have substantially the same
scope as the claims here, hence the "same invention" double patenting
rejections made in both cases. A different examiner rejected the claims for
obviousness over different combinations of art than in this case.
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subject matter defined by claims 1 and 16 [and the respective dependent
claims] are rendered unclear." Id. The Examiner asserts that the "structure"
and the "frangible material" recited in claim 1, for example, may be
interpreted as two separate elements or as the same thing. Id.; Ans. 2-3.
We do not agree with the Examiner's interpretation. As Appellants
point out, the "structure" and the "frangible material" are "two different
elements of the claim." Br. 5. They may be made of the same or different
compounds/substances, but that does not demonstrate indefiniteness. To the
contrary, the "structure" defines certain shape and dimensional
characteristics of the occlusive device - providing "pre-established pore
features" and a size that is suitable for insertion into a patient's vasculature.
Br. 8. The "frangible material," on the other hand, defines a further feature
of the pores themselves, specifically a material "associated with" the pores
that is capable of providing, e.g., localized rupturing or eroding under
differential pressure. Id. On this record, we conclude that the claims are
reasonably clear and definite.
ANTICIPATION
The Examiner has rejected independent claims 1 and 16 ( and several
dependent claims) as anticipated by Molaei. Final Act. 8-11. The Examiner
finds that Molaei' s Figure 8 ( and features of the device shown in that figure)
meets all the limitations of claims 1 and 16. Id. at 8-10. Figure 8a of
Molaei is reproduced below.
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sso -
Figure 8a of Molaei depicts an endoprosthesis (350) with degradable layers
(354). Molaei ,r 70. Molaei describes that the tubular member (351)
includes a plurality of fenestrations (353) that are initially occluded by a
degradable layers (354), thus initially obstructing passage between the
interior and the exterior of a blood vessel. Id. After the endoprosthesis is
deployed, "layer 354 degrades and may open fenestrations 353 entirely,"
such as shown in Molaei's Figure 8b. Id.; see also id. at Fig. 8b.
According to the Examiner, the embodiment in Molaei's Figure 8
shows a first condition where a frangible material is non-degraded and
shows a second condition where the material is fully degraded. Final Act.
8-9. Because the Examiner reasons that "material degrades in the presence
of blood flow, under any pressure differential," the Examiner finds Molaei's
Figure 8 meets the claim requirement that the material is capable of eroding
in the presence of a localized pressure differential arising at the ostium of a
perforator vessel. Id. Regarding the recitation in claim 1 of the frangible
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material remaining intact at a net-zero pressure differential arising at an
aneurysm of the vessel, the Examiner finds that the frangible material shown
in Molaei may remain intact immediately after deployment or without blood
flow. Id. at 9.
Appellants contend that the "degradable layer 354 [ofMolaei] will
degrade regardless of pressure differential as admitted by the Examiner,"
and thus "Molaei fails to anticipate the present invention" because claim 1
requires the frangible material be capable of localized eroding/rupturing at a
differential pressure at an ostium of a perforator vessel, while remaining
intact at a net-zero pressure differential arising at an aneurysm of the vessel.
Br. 5---6.
[U]nless a [prior art] reference discloses within the four comers
of the document not only all of the limitations claimed but also
all of the limitations arranged or combined in the same way as
recited in the claim, it cannot be said to prove prior invention of
the thing claimed and, thus, cannot anticipate under 35 U.S.C.
§ 102.
Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
We are unpersuaded the Examiner has shown by a preponderance of
the evidence that the embodiment cited in Molaei meets all the limitations of
claims 1 and 16. It is not clear, nor is it necessarily the case, that the
degradable layer (354) covering the fenestrations (353) in Molaei's Figure 8
would exhibit the characteristics of the frangible material recited in the
claims - remaining intact at the site of an aneurysm but selectively
rupturing or eroding at the site of openings to perforator vessels based on a
differential pressure. Other teachings and embodiments in Molaei
( discussed below) suggest modifications that would appear to provide these
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features, but the Examiner has not adequately cited to them. To the extent
that picking from among distinct teachings in Molaei is appropriate, such
picking and choosing invokes the issue of obviousness, not anticipation. In
re Arkley, 455 F.2d 586, 587 (CCPA 1972) ("[P]icking and choosing may be
entirely proper in the making of a 103, obviousness rejection ... but it has
no place in the making of a 102, anticipation rejection").
For the reasons above, we reverse the rejection of claims 1 and 16
( and the respective dependent claims) as anticipated by Molaei.
OBVIOUSNESS
The Examiner rejected dependent claims 5, 7, 19, and 20 as obvious
over Molaei, and claims 10-13, 22, and 23 as obvious over Molaei and
Boismier. Final Act. 12-14. Those rejections, however, rely on the same
limited teachings cited and unpersuasive analysis related to Molaei discussed
above concerning the anticipation of independent claims 1 and 16. For that
reason, we also reverse the rejections for obviousness on appeal.
NEW GROUND OF REJECTION
As explained further below, we enter a New Ground of Rejection of
claims 1 and 16 under 35 U.S.C. § 103(a) as obvious over Molaei (or Molaei
combined with Boismier). 6
6 Should there be further prosecution, we leave to the Examiner to determine
whether to reject any of other claims based on the combined art cited here or
found in the related appeal discussed above. See 37 C.F.R. § 4I.50(b); see
also Manual of Patent Examining Procedure (MPEP) § 1213.02. Under 37
C.F .R. § 41.50(b ), the Board may, in its decision, make a new rejection of
one or more of any of the claims pending in the case. Because the authority
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Molaei teaches an endoprosthesis that modifies the amount of velocity
of blood passing between a primary vessel and an aneurysm in that vessel.
Molaei ,r 32, Figs. la, lb. According to Molaei, such a prosthesis
can be deployed to divert, reduce or block blood flow between
vessel 26 and aneurysm 25. The endoprosthesis can also reduce
blood flow between vessel 26 and a feeder vessel 27. If so
deployed, prosthesis 100 may sufficiently reduce blood flow to
allow clotting or other healing processes to take place within
aneurysm 25 and/or opening 29 . ... Prosthesis 100 can also (or
alternatively) allow blood to pass between vessel 26 containing
the prosthesis and adjacent vessels, e.g., feeder vessel 27, while
still providing reduced flow with respect to the aneurysm.
Id. In other words, Molaei teaches that it may be desirable to design an
endoprosthesis that blocks ( or substantially blocks) flow to an aneurysm
while allowing some flow from the vessel through the device and into feeder
(i.e., perforator) vessels.
Molaei goes even further in this regard. In embodiments, Molaei
discloses that portions of the endoprosthesis (e.g., a center portion 326 as
shown in Fig. 7b) may be structured to limit or prevent flow to an aneurysm,
but allow flow to feeder vessels. Molaei ,r 65 ( also noting that the center
portion may itself include fenestrations), Figs. 7 a, 7b. According to Molaei,
in embodiments, "[ o ]ver time following deployment, e.g., weeks, months, or
even several years, center portion 326 degrades." Id. ,r 66. Moreover,
Molaei discloses that "[i]n other embodiments, center portion 326 includes a
under 37 C.F.R. § 4I.50(b) is discretionary, no inference should be drawn
from the decision to exercise that discretion with respect to some but not all
of the claims on appeal.
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biodegradable portion and another portion, which is either not biodegradable
or has a significantly different degradation lifetime." Id. ,r 67. For example,
Molaei teaches that
[a] first portion . . . has a short degradation lifetime and is
oriented to face feeder 27. A second portion . . . has a longer
degradation lifetime as is oriented to face aneurysm 25.
Accordingly, prosthesis 325 can provide both rapid
reestablishment of flow between a vessel weakened by an
aneurysm and a [feeder] vessel branching therefrom and long-
term flow reduction with respect to the aneurysm itself.
Id. Molaei further teaches that markers may be included on the
prosthesis/stent that aid with positioning of the prosthesis with respect to the
aneurysm and feeder vessels. Id. Hence, the skilled person would
understand that Molaei suggests that certain portions of the endoprosthesis
facing an aneurysm may be tailored to biodegrade slowly ( or not at all)
while other portions adjacent feeder vessels are designed to degrade rapidly
to reestablish flow between the vessel and the feeders.
In other embodiments, including the one relied upon by the Examiner,
Molaei describes an endoprosthesis that includes a plurality of
circumferential fenestrations (i.e., pore features) that are covered by
degradable layers. Id. ,r 70. Molaei discloses that the degradable layers may
degrade upon deployment in the vessel to open the fenestrations. Id. And,
like other embodiments, Molaei teaches that markers may be included to
indicate the orientation of the fenestrations relative to an aneurysm or feeder
vessels. Id. ,r 71.
Molaei teaches that several biodegradable polymers may be used with
its embodiments. Among those polymers, Molaei identifies polyglycolic
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acid and polycaprolactone. Id. ,r 47. Molaei also teaches, in embodiments,
that the polymers may be provided in coatings of various thicknesses, e.g.,
35 µm. Id. ,r 69; see also id. ,r 61 (describing use of polymer bands having a
thickness of "about 50% of a ... thin film [less than about 50 µm (i-f 8) ],"
hence about 25 µm or less). Molaei teaches that polymers may be selected
based on the mechanical or chemical properties desired. Id. ,r,r 41--42.
Based on the foregoing, it would have been obvious to design an
occlusive device like one shown in Molaei's Figure 8, which includes
several fenestrations (pores) along its length. It would have further been
obvious to design or modify the degradable polymer layer associated with
those fenestrations so that some portions ( those facing feeder vessels) of the
polymer will rupture or erode rapidly, while other portions (those facing an
aneurysm) will erode slowly, or not bioerode at all. The skilled person
would have been motivated to make this modification with a reasonable
expectation of success based on the express teachings of Molaei, which
describe the advantages of including a material that erodes in a differential
pattern. See, e.g., id. ,r,r 32, 65----67. And this would involve little more than
either substituting or slightly modifying the biodegradable layers in one
embodiment for another. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,417
(2007) ("If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability. ").
As noted above, Molaei also discloses that the biodegradable
polymers may include polyglycolic acid or polycaprolactone. Appellants'
Specification and claims use the same polymers for forming the recited
"frangible material." See Spec. ,r 18; Br. 8 (pending claim 4). As evidenced
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by Boismier, it was known in the art that polyglycolic acid (PGA) bioerodes
quickly and polycaprolactone more slowly. Boismier ,r,r 8, 65. Molaei also
suggests thicknesses for its polymer layers ( e.g., 35 µm) that squarely falls
within the range of acceptable thicknesses for the frangible material
described and claimed by Appellants. Spec. ,r 18; Br. 9 (pending claim 6
(reciting a range of 10-500 microns)).
We thus find, under these circumstances, that Molaei teaches or
suggests a substantially identical device and method compared to what is
claimed. Absent persuasive evidence to the contrary, a device constructed
by following Molaei's teachings would include the claimed "frangible
material" and would be expected to exhibit the selective rupturing or eroding
at the different pressures recited in the claim. See In re Best, 562 F.2d 1252,
1255 (CCPA 1977).7
For the reasons above, we conclude claims 1 and 16 would have been
obvious over Molaei ( or Molaei in combination with Boismier).
7 To the extent Appellants' argument (Br. 5) suggests that the phrase "the
frangible material remaining intact in the presence of a net-zero pressure
differential arising at an aneurysm of a vessel" requires absolutely no
erosion of the material at that site or that the material remain intact
permanently, we are not persuaded that this is the broadest reasonable
interpretation of the claims. To the contrary, the Specification states that the
device "substantially block[ s] flow into the aneurysm" and further indicates
that preferably the frangible material provides a flow barrier at the neck of
the aneurysm for eight to twelve weeks. Spec. ,r,r 16, 37.
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SUMMARY
We reverse the rejections for indefiniteness, anticipation, and
obviousness on appeal. We enter a New Ground of Rejection of claims 1
and 16 under 35 U.S.C. § 103.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
( 1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MANUAL OF PATENT EXAMINING PROCEDURE§ 1214.01 (9th
Ed., Rev. 07.2015, Nov. 2015).
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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)(iv).
REVERSED; 37 C.F.R. § 4I.50(b)
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