Healionics Corporation

Patent Trials and Appeals Board

Apr 8, 2020

14627871 - (D) (P.T.A.B. Apr. 8, 2020)

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.
14/627,871 02/20/2015 Andrew J. Marshall 440090.406 4977
500 7590 04/08/2020
SEED INTELLECTUAL PROPERTY LAW GROUP LLP
701 FIFTH AVE
SUITE 5400
SEATTLE, WA 98104
EXAMINER
PRONE, CHRISTOPHER D
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
04/08/2020 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):
USPTOeAction@SeedIP.com
pairlinkdktg@seedip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ANDREW J. MARSHALL, MAX MAGINNESS,
ADRIENNE ODA, and BRANDT SCANLAN
__________

Appeal 2019-006065
Application 14/627,871
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

REIMERS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, 4–10, 14, and 15. Claims 3 and
11–13 have been withdrawn from consideration. Appeal Br. 4. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Healionics
Corporation. Appeal Brief (“Appeal Br.”) 2, filed Mar. 15, 2019.
Appeal 2019-006065
Application 14/627,871

2
CLAIMED SUBJECT MATTER
The claimed subject matter “relates to vascular grafts, such as
artificial blood vessels.” Spec. 1:8.
Claim 1, the sole independent claim on appeal, is representative of the
claimed subject matter and recites:
1. A vascular graft comprising:
a blood-contacting layer formed of a first microporous
biomaterial;
a nonporous intermediate layer; and
a tissue-interface layer having a textured microporous
surface, the tissue-interface layer being configured to contact
host tissue and being formed of a second microporous
biomaterial having interconnected pores with mean pore
diameter ranging from 10 to 100 micrometers, wherein the
textured microporous surface is capable of reducing fibrotic
capsular formation.

THE REJECTION
Claims 1, 2, 4–10, 14, and 15 stand rejected under 35 U.S.C. § 103 as
unpatentable over Sowinski (US 2003/0017775 A1, published Jan. 23, 2003)
and Ratner (US 8,318,193 B2, issued Nov. 27, 2012).

ANALYSIS
Appellant does not offer arguments in favor of dependent claims 2, 4–
10, 14, and 15 separate from those presented for independent claim 1.
Appeal Br. 11–17. We select claim 1 as the representative claim, and claims
2, 4–10, 14, and 15 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Sowinski discloses a vascular graft having
most of the limitations of claim 1 including a tissue-interface layer (first
Appeal 2019-006065
Application 14/627,871

3
layer 12) having a textured microporous surface, the tissue-interface layer
being configured to contact host tissue and being formed of a second
microporous biomaterial having interconnected pores. Final Act. 42 (citing
Sowinski ¶¶ 29–31); see also Sowinski Fig. 1. The Examiner acknowledges
that Sowinski does not disclose the pores of its tissue-interface layer have a
mean diameter ranging from 10 to 100 micrometers. Id. The Examiner,
however, finds that Ratner discloses “vascular biomaterials” that have pore
diameter “ranging from about 20 to about 90 micrometers (Abstract) in order
to promote angiogenesis around the implantable device.” Id. The Examiner
concludes that it would have been obvious to a skilled artisan to modify the
vascular graft of Sowinski to form its tissue interface layer “with a mean
pore diameter size between 20 and 90 micrometers in order to provide
optimal materials for angiogenesis around the implant site.” Id.
Appellant contends that “the Examiner has not shown that ‘promoting
angiogenesis’ motivates a skilled person in the art to modify the textile
coating of Sowinski’s graft.” Appeal Br. 13. Appellant points out that
“Sowinski teaches that the textile coating enhances tissue ingrowth, thus
assimilating the graft into the tissue and providing high suture retention
strength (a consequence of increased fibrotic tissue ingrowth)” (id. (citing
Sowinski ¶¶ 4, 20)), that “Ratner’s microporous material was designed to
promote blood vessel ingrowth into the tightly size-controlled pores (e.g., in
the range of 10–100 microns),” and that “Ratner shows the impact of the
pore dimensions on blood vessel densities formed inside the microporous

2 Final Office Action (“Final Act.”), dated Apr. 10, 2018.
Appeal 2019-006065
Application 14/627,871

4
material” (id. (citing Ratner Table 3)). According to Appellant, “[c]iting no
evidence that Sowinski would benefit from blood vessel ingrowth (or
angiogenesis), the Examiner fails to articulate a rationale for combining the
teachings of Sowinski and Ratner.” Id. at 13–14; see also Reply Br. 2–3.3
Appellant’s contentions are unpersuasive. Notably, Sowinski’s
disclosure is directed to implantable prostheses including vascular grafts.
See Sowinski Abstr., ¶ 3. Ratner’s biomaterial is also directed to vascular
grafts as Ratner discloses that “[p]orous biomaterials are used in a variety of
implantable medical devices, including sutures and vascular grafts” and that
“[t]here is a continuing need for porous biomaterials that promote
vascularization in and around the implant and reduce the foreign body
reaction.” Ratner 1:30–31, 39–41 (emphasis added). Thus, Ratner
explicitly discloses a motivation for modifying Sowinski’s vascular graft,
namely, “promot[ing] vascularization in and around the implant and
reduc[ing] the foreign body reaction.” See id. Appellant does not direct us
to any passages in Sowinski that teach away from having pores with the size
range disclosed in Ratner. Appellant also does not direct us to a
requirement––and we are unaware of any––that the primary reference, i.e.,
Sowinski, in a combination concerning obviousness, must disclose the same
benefit as that of the secondary reference, i.e., Ratner.
Appellant contends that “the state of the art of vascular graft at the
time of [the] invention discouraged angiogenesis as it was believed to
worsen neointimal hyperplasia, a primary failure mode of the vascular graft”

3 Reply Brief (“Reply Br.”), filed Aug. 12, 2019.
Appeal 2019-006065
Application 14/627,871

5
(Appeal Br. 13) and points out that the Marshall Declaration4 indicates that
angiogenesis promotes neointimal hyperplasia (NH) development (id. at 14
(citing Marshall Declaration 4)).
Appellant’s reliance on the Marshall Declaration is unavailing. We
first note that Dr. Marshall is a co-inventor of the instant application, and,
thus, is an interested party. Further, the Examiner correctly responds that
the [Marshall Declaration] provides opinions of a named
inventor of the application not conclusive facts accept[ed] by
everyone of skill in the art of vascular grafts. While some people
in the art may have agreed with the inventor, everyone in the field
of vascular grafts did not. Specifically the cited reference Ratner
is one clear example of public knowledge within the field of
vascular grafts who wanted to encourage angiogenesis using an
even more refined pore range.
Ans. 6–7.5 The Examiner further points out that paragraph 3.6 of the
Marshall Declaration states that “there are multiple graft failure modes, and
addressing one failure mode may lead to a different failure mode.” Id. at 7
(quoting Marshall Declaration 5 (emphasis added)). We thus agree with the
Examiner that “[t]he [Marshall Declaration] fails to conclusively prove that
the results [i.e., alleged failure of the vascular grafts] are due to the claimed
pore size feature and not other features.” Id. (emphases added).
It seems to us that if the range of pore size disclosed by Ratner
produces the negative result of neointimal hyperplasia, then Appellant’s
vascular graft would also produce such a result. Moreover, even if the pore
size range of Ratner produces the negative result of neointimal hyperplasia,

4 Declaration of Dr. Andrew Marshall (“Marshall Declaration”), filed Dec.
29, 2017. Appeal Br. 14.
5 Examiner’s Answer (“Ans.”), dated June 13, 2019.
Appeal 2019-006065
Application 14/627,871

6
that would not necessarily mean that the subject matter of claim 1 is
nonobvious because Ratner also discloses the “benefit” of reducing the
foreign body reaction (see Ratner 1:39–41) and a skilled artisan would
weigh the advantages and disadvantages of the pore size range. See
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006)
(“[O]bviousness must be determined in light of all the facts, and there is no
rule that a single reference that teaches away will mandate a finding of
nonobviousness. Likewise, a given course of action often has simultaneous
advantages and disadvantages, and this does not necessarily obviate
motivation to combine.”). A combination of reference teachings may be
obvious even if the combination eliminates a benefit of one of the
references. See In re Urbanski, 809 F.3d 1237, 1242 (Fed. Cir. 2016).
Appellant next argues that the subject matter of claim 1 is not obvious
because it relies on the discovery of the source of a problem. Appeal Br. 14.
According to Appellant, it is the present inventors who discovered that
“fibrotic capsular formation and the resultant external constriction as the
source of occlusive failure” in vascular grafts. Id.; see also Reply Br. 3–4.
However, “[t]he fact that [A]ppellant has recognized another
advantage[,] which would flow naturally from following the suggestions of
the prior art cannot be the basis for patentability when the differences would
otherwise be obvious.” See Ex Parte Obiaya, 227 USPQ 58, 61 (BPAI
1985). “Mere recognition of latent properties in the prior art does not render
nonobvious an otherwise known invention.” In re Baxter-Travenol Labs.,
952 F.2d 388, 392 (Fed. Cir. 1991). We further note that this argument is
unpersuasive because the Examiner’s reasoning for modifying the vascular
graft of Sowinski to have the particular pore size need not be the same as
Appeal 2019-006065
Application 14/627,871

7
Appellant’s reason for having that structure. “In determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls. . . . [A]ny need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419–20 (2007); see
also In re Kahn, 441 F.3d 977, 987–88 (Fed. Cir. 2006) (establishing that the
reason to modify the reference may often prompt a person of ordinary skill
in the art to do what the inventor has done, but for a different purpose or to
solve a different problem. It is not necessary that the prior art suggests the
combination to achieve the same advantage or result discovered by an
applicant).
Lastly, Appellant contends that the subject matter of claim 1 is not
obvious because it confers unexpected advantages over the prior art. Appeal
Br. 15. Appellant points to the results disclosed in the Specification’s
Figures 17A–17B and 13A–13B and what is discussed in the Marshall
Declaration. Appeal Br. 15–17; see also Reply Br. 4–5.
As an initial matter, we note that the Figures disclosed in Exhibit II
that accompany the Marshall Declaration (see Marshall Declaration 13),
which are described in paragraph 5.3 of the Marshall Declaration, are the
same as Figures 13A–13B of the Specification. Cf Marshall Declaration 7,
13 with Spec. Figs. 13A–13B; Appeal Br. 17. In other words, Appellant
does not submit new evidence in Exhibit II of the Marshall Declaration that
is different than that which is already discussed/described in the
Specification. We further note that Appellant’s described unexpected
advantages, such as “the preservation of the original lumen diameter along
Appeal 2019-006065
Application 14/627,871

8
the entire length of the graft” and “the ability to reduce neointimal
hyperplasia at the outflow anastomosis, have compounding beneficial effects
in preventing the problem of stenosis failure at the outflow anastomosis”
(Appeal Br. 17), are not claimed. See In re Self, 671 F.2d 1344, 1348
(CCPA 1982) (“[A]ppellant’s arguments fail from the outset because . . .
they are not based on limitations appearing in the claims.”).
We agree with the Examiner that these arguments are unpersuasive for
three reasons. First, “when unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” See Baxter-Travenol Labs., 952 F.2d at 392.
Appellant compares the subject invention’s vascular grafts with those
described as “conventional ePTFE graft” or grafts “with regular wall of 6
mm with no radial reinforcement.” See Spec. 4:7–9, 16:6–7. These grafts
do not appear to be the closest prior art, such as the grafts of Sowinski,
which have all the features of claim 1 except the claimed pore size of the
tissue-interface layer. See Ans. 8–9.
Second, Ratner already discloses the same “unexpected advantages”
that Appellant contends that the subject invention confers. Appellant’s
Specification describes that the subject invention “constrain[s] the invading
macrophage cells and prevent[s] them from spreading.” Spec. 8:10; see also
id. at 7:17–21 (disclosing that macrophages induce fibrotic encapsulation,
which Appellant’s aim is to limit). In other words, Appellant’s Specification
describes that the subject invention’s vascular graft prevents or reduces
macrophage attack, i.e., a foreign body reaction when an implant is
introduced into the body. However, Ratner also discloses the advantage of
Appeal 2019-006065
Application 14/627,871

9
“reduc[ing] the foreign body reaction.” Ratner 1:39–41; see also id. at 6:40–
42; Ans. 8–9.
Third, even if crediting Appellant’s contention that Figures 13A–13B
and 17A–17B of the Specification demonstrate unexpected results, we are
not persuaded that such results place Appellant in a better position here,
particularly when the evidence of obviousness is so strong. See Pfizer Inc. v.
Apotex Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) (“[W]e hold that even if
Pfizer showed that amlodipine besylate exhibits unexpectedly superior
results, this secondary consideration does not overcome the strong showing
of obviousness in this case. Although secondary considerations must be
taken into account, they do not necessarily control the obviousness
conclusion.”). As noted above, Ratner explicitly discloses porous
biomaterials that reduce foreign body reaction. See Ans. 8–9.
After reviewing all the evidence before us, including the totality of
Appellant’s evidence, it is our conclusion that, on balance, the evidence of
obviousness discussed above outweighs the evidence of nonobviousness
submitted by Appellant and, accordingly, the subject matter of claim 1
would have been obvious to one of ordinary skill in the art within the
meaning of 35 U.S.C. § 103 at the time Appellant’s invention was made.
In summary, and based on the record presented, we sustain the
Examiner’s rejection of independent claim 1 as unpatentable over Sowinski
and Ratner. We further sustain the Examiner’s rejection of claims 2, 4–10,
14, and 15, which fall with claim 1.

Appeal 2019-006065
Application 14/627,871

10
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§ 
Reference(s)/Basis Affirmed Reversed
1, 2, 4–10,
14, 15
103  Sowinski, Ratner 1, 2, 4–10,
14, 15

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)(1)(iv).

AFFIRMED