Dietmar SONNLEITNER

Patent Trials and Appeals Board

Dec 2, 2020

2020002909 (P.T.A.B. Dec. 2, 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.
15/227,384 08/03/2016 Dietmar SONNLEITNER 2016-1049A 7971
513 7590 12/02/2020
WENDEROTH, LIND & PONACK, L.L.P.
1025 Connecticut Avenue, NW
Suite 500
Washington, DC 20036
EXAMINER
HOBAN, MELISSA A
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
12/02/2020 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):
eoa@wenderoth.com
kmiller@wenderoth.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte DIETMAR SONNLEITNER
____________

Appeal 2020-002909
Application 15/227,384
Technology Center 3700
____________

Before BENJAMIN D. M. WOOD, BRETT C. MARTIN, and
WILLIAM A. CAPP, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant seeks our review under 35 U.S.C. § 134(a) of the non-final
rejection of claims 1–7, 12–17, 20, 21, and 24–32. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
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THE INVENTION
Appellant’s invention is a film that covers a bone defect site.
Spec. ¶ 1.1 Claim 1, reproduced below, is illustrative of the subject matter
on appeal.
1. A pre-bonded multilayer film for covering a bone
defect site, the pre-bonded multilayer film including:
a shaping molding layer for shaping the pre-bonded
multilayer film to the bone defect site and at least one cover
layer for covering the bone defect site,
wherein:
the shaping molding layer and the at least one cover layer
are completely resorbable,
the at least one cover layer consists essentially of a
bioresorbable collagen material, and
the shaping molding layer at least partially comprises a
bioresorbable polymer material.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Name Reference Date
McKay US 2008/0044449 A1 Feb. 21, 2008
Bartee US 2010/0217392 A1 Aug. 26, 2010
Armbruster US 2012/0107407 A1 May 3, 2012
The following rejections are before us for review:
1. Claims 1–7, 12–17, 20, 21, and 24–32 are rejected under 35 U.S.C.
§ 112(a) for failure to comply with the written description requirement.

1 Paragraph citations to Appellant’s Specification herein shall be to the
Printed Publication version of Appellant’s Disclosure US 2016/0338836 A1,
pub. Nov. 24, 2016.
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2. Claims 1, 2, 5, 6, 14, 15, 17, 20, 24–27, and 30 are rejected under
35 U.S.C. § 102 as being anticipated by McKay.
3. Claim 16 is rejected over McKay under 35 U.S.C. § 102 or, in the
alternative, under 35 U.S.C. § 103.
4. Claims 7, 12, and 13 are rejected under 35 U.S.C. § 103 as being
unpatentable over McKay.
5. Claims 3, 4, and 31 are rejected under 35 U.S.C. § 103 as being
unpatentable over McKay and Armbruster.
6. Claims 12, 13, 16, 21, 28, 29, and 32 are rejected under 35 U.S.C.
§ 103 as being unpatentable over McKay and Bartee.
OPINION
Written Description
Claims 1–7, 12–17, 20, 21, and 24-32
Claim 1 recites a cover layer that “consists essentially of” a
bioresorbable collagen material. Claims App. A substantially similar
limitation also appears in independent claim 32. Id. As we understand the
Examiner’s rejection, although Appellant’s disclosure describes a cover
letter that comprises a bioresorbable collagen material, it does not do so in a
manner that limits the amount of additional unclaimed elements that may
accompany the claimed elements and, therefore, fails to provide disclosure
that conforms to the “consists essentially of” claim language. Non-Final
Act. 4.
Appellant directs our attention to paragraphs 15 and 42 of the
Specification as providing written description support for the claim passage
in question. Appeal Br. 5. Paragraph 15, in part, provides:
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For good resorption capability of the proposed film it can be
provided that the at least one cover layer at least partially and
preferably substantially completely comprises a bioresorbable
collagen material.
Spec. ¶ 15; see also Id. ¶ 42 (“The cover layers 4a and 4b can for example
comprise bioresorbable collagen membranes”).
In response, the Examiner maintains that, by using the “consisting
essentially of” transition phrase, Appellant bears the burden of showing that
introducing additional steps or components would materially change the
characteristics of the invention. Ans. 4. In reply, Appellant takes the
position that the Examiner’s concerns are more properly directed to
distinguishing the invention over the prior art than challenging whether there
is written description support for the invention. Reply Br. 4.
The phrase “consisting essentially of” is a transition that is commonly
used to signal a partially open claim in a patent. PPG Industries v.
Guardian Industries Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). A
“consisting essentially of” claim occupies a middle ground between closed
claims that are written in a “consisting of” format and fully open claims that
are drafted in a “comprising” format. Id.
Typically, “consisting essentially of” precedes a list of
ingredients in a composition claim or a series of steps in a
process claim. By using the term “consisting essentially of,” the
drafter signals that the invention necessarily includes the listed
ingredients and is open to unlisted ingredients that do not
materially affect the basic and novel properties of the invention.
Id.
Appellant provides adequate written description support for the claim
limitation at issue. The Examiner errs in requiring Appellant to shoulder
the burden of providing written description support for the exclusion of
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unclaimed subject matter that might affect the basic and novel properties of
the invention. “In view of the ambiguous nature of the [consisting
essentially of] phrase, it has long been understood to permit inclusion of
components not listed in the claim, provided that they do not “materially
affect the basic and novel properties of the invention.” AK Steel Corp. v.
Sollac, 344 F.3d 1234, 1239 (Fed. Cir. 2003). We agree with Appellant that
analysis of whether additional components materially affect the basic and
novel properties of the invention is better conducted in the context of a
patentability analysis under Sections 102 or 103 than under the written
description provisions of Section 112.
Consequently, we do not sustain the Examiner’s Section 112 rejection
related to the “consisting essentially of” phrase.
Claims 29 and 32
The Examiner states that there is insufficient written description
support for a shaping structure that consists of individual strut-shaped
elements with free ends as claimed in claims 29 and 32. Non-Final Act. 4–5.
Appellant argues that the drawings disclose elements with free ends as
claimed and that the Examiner has admitted as much in the Office Action
under review. Appeal Br. 6. In response, the Examiner concedes that
Appellant’s figures appear to show elements with free ends. Ans. 4. The
Examiner contends, however, that the Specification fails to show such
elements in a manner that excludes any other element, step or ingredient. Id.
We agree with both Appellant and the Examiner that there is support
in the figures for elements with free ends. We will not require Appellant to
shoulder a burden of disproving the presence of additional unclaimed
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features. Thus, we do not sustain the Examiner’s Section 112 rejection with
respect to the free ends limitation.
Anticipation of
Claims 1, 2, 5, 6, 14, 15, 17, 20, 24–27, and 30
by McKay
Appellant argues these claims as a group. Appeal Br. 6–12. Claim 1
is representative. See 37 C.F.R. § 41.37(c)(1)(iv) . The Examiner finds that
McKay discloses each and every limitation of claim 1. Non-Final Act. 5–7.
Appellant first argues that McKay fails to disclose two “distinct”
layers as claimed. Appeal Br. 8. In response, the Examiner identifies
element 91 of McKay as corresponding to Appellant’s shape molding layer
and element 92 as corresponding to Appellant’s cover layer. Ans. 5. In
reply, Appellant argues that it has conducted “field tests” that show that it is
not possible to embed a shaping molding layer in a cover layer that consists
essentially of a bioresorbable collagen material due to the consistency of
collagen. Reply Br. 7. According to Appellant, the layers of the claimed
pre-bonded multilayer film are connected together mechanically or
chemically such that a novel and inventive multilayer film is provided. Id.
Determining whether claims are anticipated involves a two-step
analysis. In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). The
first step involves construction of the claims of the patent at issue. Id.
“During examination, ‘claims ... are to be given their broadest reasonable
interpretation consistent with the specification, and ... claim language should
be read in light of the specification as it would be interpreted by one of
ordinary skill in the art.”’ Id. (quoting In re Am. Acad. of Sci. Tech. Ctr., 367
F.3d 1359, 1364 (Fed. Cir. 2004)). The second step of an anticipation
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analysis involves comparing the claims to prior art. Id. A prior art reference
anticipates a patent claim under 35 U.S.C. § 102 if it discloses every claim
limitation. Id.
McKay is directed to a sheet form medical implant device. McKay
¶ 6. McKay’s sheet includes granules of a calcium-containing osteo-
conductive material together with a web of biodegradable material that
interconnects the granules. Id. ¶ 7. McKay is used to facilitate bone growth
to repair a fracture or defect. Id. ¶ 8. McKay discloses implant sheet 90
comprised of a polymeric material 92 that incorporates granules 14. Id.
¶ 62. Implant sheet 90 further includes reinforcing mesh 91 that increases
the rigidity and/or tensile strength of the sheet. Id. Suitable material for
mesh 91 includes resorbable polymers. Id. Mesh 91 is conformable to a
desired shape at the time of surgery and will retain that shape when
implanted. Id.
[R]einforced sheet 90 can be provided in or deformed to a
shape suitable for use in cranial, maxillofacial or dento-alveolar
applications in which tissue regeneration is desired. In one
application, reinforced sheet 90 can be shaped and used for the
augmentation of a human alveolar ridge.
Id.
In view of the foregoing disclosure of McKay, Appellant’s arguments
are not persuasive. Claim 1 merely requires a first layer that is a shape
molding layer and a second layer that is a cover layer that consists
essentially of a bioresorbable collagen material. Claims App. McKay
discloses a medical implant sheet that comprises two layers. McKay ¶ 62,
Figs. 12–13. Appellant’s argument that the layers must be “distinct” to any
particular degree entails subject matter that is not claimed. Moreover,
Appellant does not articulate what it means for two layers to be “distinct” as
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opposed to less than “distinct,” much less how we are to draw a distinction
between the two. Appellant does not direct us to any disclosure in the
Specification that would guide such an inquiry. See generally Appeal Br.
Case authority establishes that prior art cannot be distinguished on the
ground that it lacks features that are not claim limitations. See, e.g., DDR
Holdings, LLC, v. Hotels.com, L.P., 773 F.3d 1245, 1252–54 (Fed.
Cir. 2014) (“Anticipation challenges under § 102 must focus only on the
limitations actually recited in the claims”).
Furthermore, Appellant’s “field test” evidence is not evidence at all.
There is no evidence appendix attached to Appellant’s Appeal Brief and
Appellant does not cite to any such evidence elsewhere in the record. Naked
representations by an attorney as to what “field tests” allegedly show does
not rise to the level of evidence that merits our consideration. In re
Cole, 326 F.2d 769, 773 (CCPA 1964) (explaining that statements by
counsel in a brief cannot take the place of actual evidence).
Appellant next argues that McKay lacks a cover sheet consisting
essentially of bioresorbable collagen material. Appeal Br. 9. In response,
the Examiner directs our attention to paragraph 34 of McKay as disclosing
collagen in its cover layer 92. Ans. 5. The Examiner further notes that, in
the absence of Appellant providing any evidence concerning the basic and
novel characteristics of a cover sheet that “consists essentially of” collagen,
McKay satisfies the limitation directed to a cover layer that consists
essentially of a bioresorbable collagen material. Id.
We agree with the Examiner that Appellant fails to identify, much less
establish, the alleged basic and novel characteristics of its collagen cover
layer. PPG, 156 F.3d at 1354–55. If Appellant contends that any additional
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materials in McKay are excluded by the recitation of “consisting essentially
of,” Appellant bears the burden of showing that the introduction of such,
otherwise unidentified, components would materially change the
characteristics of its invention. In re De Lajarte, 337 F.2d 870, 874
(CCPA 1964). Here, Appellant fails to meet its burden.
Next, Appellant argues that there would have been no motivation for
a person of ordinary skill in the art to modify McKay to provide a layer that
consists essentially of bioresorbable collagen material and that modification
to conform to the claim limitations would render McKay unsatisfactory for
its intended purpose. Appeal Br. 11. These arguments are not persuasive.
Arguments concerning a motivation to modify the prior art are not relevant
to an anticipation analysis under Section 102. See e.g., Krippelz v. Ford
Motor Co., 667 F.3d 1261, 1269 (Fed. Cir. 2012) (similarly explaining that
the concept of “teaching away” is only a component of an obviousness
analysis and is not relevant to an anticipation analysis).
Appellant argues that McKay is not suitable for use with respect to
oral surgery. Appeal Br. 11 (referring to use in oral surgery as
“impossible”). This amounts to naked attorney argument that is not
supported by evidence. Unsworn attorney argument is not evidence. Icon
Health & Fitness, Inc. v. Strava, Inc. 894 F.3d 1034, 1043 (Fed. Cir. 2017).
Similarly, attorney arguments that are unsupported by factual evidence are
entitled to little probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997). As pointed out by the Examiner, McKay explicitly discloses that
it may be used in a configuration in which a dental implant stem is received
into bone in a patient’s maxillofacial area. Ans. 5 (citing McKay, ¶¶ 61–62).
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We have considered Appellant’s remaining arguments and find them
to be unpersuasive. In view of the foregoing, we sustain the Examiner’s
Section 102 anticipation rejection of claims 1, 2, 5, 6, 14, 15, 17, 20, 24–27,
and 30.
Unpatentability of Claims 7, 12, 13, and 16
over McKay
Appellant does not argue for the separate patentability of these
claims apart from arguments presented with respect to claim 1, which we
have previously considered. Appellant’s allegations that the Examiner’s
proposed modification “fails to cure” alleged deficiencies in McKay is
unpersuasive as we previously determined that McKay is not deficient as
alleged. Appeal Br. 12. Consequently, we sustain the Examiner’s rejection
of claim 7, 12, 13, and 16. See 37 C.F.R. § 41.37(c)(1)(iv) (failure to
separately argue claims constitutes a waiver of arguments for separate
patentability).
Unpatentability of Claims 3, 4, and 31
over McKay and Armbruster
Appellant does not argue for the separate patentability of these claims
apart from their dependency on claims to which we have already sustained
the Examiner’s rejections. Appeal Br. 13. We sustain the Examiner’s
rejection of claims 3, 4, and 31. 37 C.F.R. § 41.37(c)(1)(iv).
Unpatentability of Claims 12, 13, 16, 21, 28, 29 and 32
over McKay and Bartee
Claims 12, 13, 16, 21, 28, and 29
Appellant does not argue for the separate patentability of these claims
apart from their dependency on claims to which we have already sustained
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the Examiner’s rejections. Appeal Br. 13. We sustain the Examiner’s
rejection of claims 3, 4, and 31. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 32
Claim 32 is an independent claim that is narrower than claim 1 in that
it contains limitations directed to a surface area of the shape molding layer
being smaller than the surface area of the cover layer and a shaping structure
that has strut-shaped elements with free ends. Claims App. The Examiner
relies on Bartee as disclosing these limitations and concludes that it would
have been obvious to modify McKay with the teachings of Bartee to achieve
the claimed invention. Non-Final Act. 12–15. According to the Examiner, a
person of ordinary skill in the art would have done this to facilitate
placement of the device as well as comfort and ease of insertion. Id. at 15.
Appellant argues that Bartee teaches a shaped structure of titanium
that is arranged on a Teflon membrane. Appeal Br. 15. Appellant notes that
use of such material requires a second medical procedure to remove Bartee’s
device after bone reconstruction has been effected. Id.
Bartee is directed to a device that is used to repair a bone defect.
Bartee, Abstract. Bartee discloses physical and dimensional features that
correspond to the relative size, shape and free end limitations of claim 32.
Id. ¶¶ 39–42, Figs 7–10.
Appellant’s argument does not apprise us of Examiner error. The
argument is viewed as an individual attack on a single reference in a
rejection that is based on a combination of references. It is well settled that
non-obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re
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Keller, 642 F.2d 413, 425 (CCPA 1981). It is clear from the rejection that
the Examiner is relying on McKay for the use of bioresorbable materials
and is merely relying on Bartee as demonstrating that it was known to use a
particular physical and dimensional configuration to facilitate placement and
insertion.
We sustain the Examiner’s Section 103 unpatentability rejection of
claim 32.
CONCLUSION
Claims
Rejected
§ Reference(s)
Bases
Affirmed Reversed
1-7, 12-17, 20,
21, 24-32
112 Written
Description
1-7, 12-17,
20, 21, 24-32
1, 2, 5, 6, 14, 15,
17, 20, 24-27, 30
102 McKay 1, 2, 5, 6, 14, 15,
17, 20, 24-27, 30

7, 12, 13, 16 103 McKay 7, 12, 13, 16
3, 4, 31 103 McKay,
Armbruster
3, 4, 31
12, 13, 16, 21,
28, 29, 32
103 McKay,
Bartee
12, 13, 16, 21, 28,
29, 32

Overall
Outcome
1-7, 12-17, 20,
21, 24-32

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED