Ex Parte Halle et al

Patent Trial and Appeal Board

Oct 31, 2012

12540396 (P.T.A.B. Oct. 31, 2012)

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.
12/540,396 08/13/2009 Joern-Peter Halle 3042-101RE 1222
46002 7590 10/31/2012
JOYCE VON NATZMER
AGRIS & VON NATZMER LLP
200 Madison Avenue
Suite 1901
New York, NY 10016
EXAMINER
ANGELL, JON E
ART UNIT PAPER NUMBER
1635
MAIL DATE DELIVERY MODE
10/31/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOERN-PETER HALLE, ANDREAS GOPPELT,
and PETER HOF
__________

Appeal 2012-006124
Application 12/540,396
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of diagnosing a disorder by measuring a nucleic acid level. The Examiner
rejected the claims as lacking an error correctable by reissue, for improper
recapture, as indefinite, and as failing to enable the full scope of the claims.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

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Application 12/540,396

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Statement of the Case
Background
“The invention relates to the use of alpha 1-antichymotrypsin (ACT)
polypeptides and/or nucleic acids encoding them, or of a cell which is
expressing an ACT polypeptide or a nucleic acid encoding it, for diagnosis,
treatment and/or prevention [of] poorly healing diabetes-associated and/or
poorly healing arterial wounds” (Spec. col. 1, ll. 17-22).
The Claims
Claims 1-13 are on appeal. Claims 1-4 are the original claims issued
in U.S. Patent 7,255,988, for which reissue is sought in the application on
appeal. Claims 5-13 were added to the reissue application. Claims 1 and 5
are representative and read as follows:
1. A method of diagnosing a disorder selected from the
group consisting of poorly healing diabetes-associated
wounds and poorly healing arterial wounds, in a patient, the
method comprising determining, in a wound sample from
the patient, the level of a nucleic acid encoding a
polypeptide having the sequence of SEQ ID NO: 3, wherein
a level of the nucleic acid in the wound sample from the
patient that is lower than the level in a control sample
indicates that said patient has the disorder.

5. A method of using nucleic acids encoding an ACT
polypeptide comprising:
providing a nucleic acid encoding a polypeptide
having the sequence of SEQ ID NO: 3 and using said
nucleic acid encoding ACT polypeptide for:
diagnosis, treatment and/or prevention of poorly
healing diabetes-associated and/or poorly healing arterial
wounds and/or production of a pharmaceutical for treatment
and/or prevention of poorly healing diabetes-associated
and/or poorly healing arterial wounds.
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The issues
1

A. The Examiner rejected claims 1-13 under 35 U.S.C. § 251 as being an
improper recapture of broadened claimed subject matter surrendered in the
application for the patent upon which the present reissue is based (Ans. 10-
12).
B. The Examiner rejected claims 5-13 under 35 U.S.C. § 112, second
paragraph, as indefinite (Ans. 12).
C. The Examiner rejected claims 1-13 under 35 U.S.C. § 251 for being
based on a reissue declaration that does not identify an error correctable by
reissue (Ans. 7-10).
D. The Examiner rejected claims 5-13 under 35 U.S.C. § 112, first
paragraph, as failing to reasonably provide enablement for the full scope of
the instant claims (Ans. 13-16).
A. Improper Recapture
The Examiner finds that:
the new claims are broader because there is no actual
diagnostic method step (i.e., the new claims do not include
determining wound levels compared to control levels) while
the patented claims are limited to particular determining
steps. It is noted that during prosecution of the 10/135,629
application, broad claims encompassing a method without
particular method steps were rejected under 35 USC 112,
first and second paragraphs (see 3/28/2005 Office Action

1
We note that whether a restriction is proper is not an appealable
matter, but rather a petitionable matter. The proper redress is a
petition to the Group Director of the Examiner‟s Technology
Center. See Manual of Patent Examining Procedure (MPEP)
§ 1002.02(c). Accordingly, we shall not consider Appellants‟
arguments regarding the restriction.
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and 10/18/2005 Office Action). In response to the
rejection(s), Applicant amended the claims to narrow the
scope by adding specific method steps, thus giving up (i.e.,
surrendering) the broader subject matter.

(Ans. 11-12).
Appellants “submit that, in agreement with the MPEP, the reported
cases involving the recapture rule consistently applied the rule only in the
context of prior art rejections” (Reply Br. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that claims 5-13 represent an improper
recapture of broadened claimed subject matter surrendered in the application
for the patent upon which the present reissue is based?
Findings of Fact
1. Issued Claim 1 of US 7,255,988 reads as follows:
1. A method of diagnosing a disorder selected from the
group consisting of poorly healing diabetes-associated
wounds and poorly healing arterial wounds, in a patient, the
method comprising determining, in a wound sample from
the patient, the level of a nucleic acid encoding a
polypeptide having the sequence of SEQ ID NO: 3, wherein
a level of the nucleic acid in the wound sample from the
patient that is lower than the level in a control sample
indicates that said patient has the disorder.

2. Original claim 1 of US application 10/135,629 reads as follows:
A method of diagnosing a disorder selected from the group
consisting of poorly healing diabetes-associated wounds,
and poorly healing arterial wounds, in a patient, the method
comprising determining in a sample from the patient, a level
of at least one compound selected from the group consisting
of an ACT polypeptide having an amino acid sequence
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according to SEQ ID No. 1 to SEQ ID No.4, and a nucleic
acid coding for the polypeptide, the level of the polypeptide
or the nucleic acid in the sample from the patient that differs
from the level in a control sample indicating that said patient
has the disorder.

3. The non-final rejection of March 28, 2005 rejected the full
scope of claim 1 under 35 U.S.C. § 112, first paragraph since “the only
result which can be indicative that the wound is a poor healing wound is
when the level of ACT expression is less than a control (wherein the control
is ACT expression in wound tissue [o]f a normal subject)” (Nonfinal Rej.
10/135,629, 3/28/2005 at 9). The non-final rejection of March 28, 2005 also
rejected claim 1 under 35 U.S.C. § 112, second paragraph as indefinite “for
omitting essential steps, such omission amounting to a gap between the
steps” (Nonfinal Rej. 10/135,629, 3/28/2005 at 4).
4. The Amendment filed in response to the March 28, 2005 non-
final rejection amended claim 1 to require “wherein a level of the nucleic
acid in the wound sample from the patient that is lower than the level in a
control sample indicates that said patient has the disorder” (Amendment
filed Aug. 1, 2005, page 2). Appellants argued at the time that the
Examiner‟s rejection under 35 U.S.C. § 112, second paragraph, should be
withdrawn because “the claim requires that the nucleic acid level in the
patient wound sample be compared with the nucleic acid level of a control
sample and that a decreased level of nucleic acid in the patient sample is
diagnostic of a poorly healing diabetes-associated or arterial wound” (id. at
8).

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Principles of Law
The recapture rule “prevents a patentee from regaining through
reissue the subject matter that he surrendered in an effort to obtain allowance
of the original claims.” In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997).
Application of the recapture rule is a three step process ….
The first step is to determine whether and in what aspect the
reissue claims are broader than the patent claims…. [A]
reissue claim that deletes a limitation or element from the
patent claims is broader with respect to the modified
limitation…. Next, the court must determine whether the
broader aspects of the reissue claims relate to surrendered
subject matter…. To determine whether an applicant
surrendered particular subject matter, we look to the
prosecution history for arguments and changes to the claims
made in an effort to overcome a prior art rejection…. [In]
the third step of the recapture analysis … the court must
determine whether the surrendered subject matter has crept
into the reissue claim.

In re Mostafazadeh, 643 F.3d 1353, 1358 (Fed. Cir. 2010) (internal citations
and quotation marks omitted).
“In discussing this third step, it is important to distinguish among the
original claims (i.e., the claims before the surrender), the patented claims
(i.e., the claims allowed after surrender), and the reissue claims.” Id. Thus,
“recapture may be avoided under this final step of the analysis if the reissue
claims „materially narrow‟ the claims relative to the original claims such that
full or substantial recapture of the subject matter surrendered during
prosecution is avoided.” Id. (quoting N. Am. Container, Inc. v. Plastipak
Packaging, Inc., 415 F.3d 1335, 1349 (Fed. Cir. 2005).

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Analysis
We begin by noting that claims 1-4, the originally issued claims of the
„988 patent, are not subject to this rejection because there is no recapture of
any subject matter in these claims.
We agree with the Examiner that reissue claim 5 is broader than the
original patent claims because reissue claim 5 lacks the “is lower than”
limitation found in issued claim 1 (FF 1-2). That is, claim 5 lacks the
limitation in issued claim 1 “wherein a level of the nucleic acid in the wound
sample from the patient that is lower than the level in a control sample
indicates that said patient has the disorder” (FF 1; emphasis added).
We also agree with the Examiner that the “is lower than” limitation
was added in response to rejections under 35 U.S.C. § 112, first and/or
second paragraph in the non-final rejection of March 28, 2005 (FF 3-4).
Lastly, we agree with the Examiner that “applicant did not materially
narrow the claims in other respects” (Ans. 12).
Appellants “submit that, in agreement with the MPEP, the reported
cases involving the recapture rule consistently applied the rule only in the
context of prior art rejections” (Reply Br. 5).
We are not persuaded. In Ex parte Russo, 2007 WL 433615 (BPAI
2007), the Board (in a non-precedential opinion) addressed the argument that
“recapture cannot apply apart from a prior art rejection.” Id. at *4. The
Board found that:
we adopt as our holding what appears to be dicta in MBO
Laboratories, Inc. v. Becton, Dickinson & Company, No.
2006-1062, slip. op. at 12-13 (Fed. Cir. Jan. 24, 2007):

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The recapture rule is a limitation on the ability of patentees
to broaden their patents after issuance. ….Section 251 is
“remedial in nature, based on fundamental principles of
equity and fairness, and should be construed liberally.”
However, the remedial function of the statute is limited.
Material which has been surrendered in order to obtain
issuance cannot be reclaimed via Section 251: … It is
critical to avoid allowing surrendered matter to creep back
into the issued patent, since competitors and the public are
on notice of the surrender and may have come to rely on the
consequent limitations on claim scope. … The recapture rule
thus serves the same policy as does the doctrine of
prosecution history estoppel: both operate, albeit in different
ways, to prevent a patentee from encroaching back into
territory that had previously been committed to the public.
(citations omitted.)

As a matter of law, we conclude that a recapture rejection
may be based on a lack of enablement rejection made during
prosecution of the application into the patent sought to be
reissued.

Id. at *4-*5. We agree with Russo that the policy rationale of notice which
underlies the recapture rule supports the conclusion that the prohibition on
recapture should not be limited to prior art rejections, but should apply to
claim amendments made to overcome enablement and indefiniteness
rejections as well.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that
claims 5-13 represent an improper recapture of broadened claimed subject
matter surrendered in the application for the patent upon which the present
reissue is based. However, the Examiner‟s rejection of claims 1-4 on this
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basis is reversed. Claims 1-4 are the claims issued in the „988 patent and
therefore do not attempt to recapture surrendered subject matter.
B. 35 U.S.C. § 112, second paragraph
The Examiner finds that “[c]laims 5-13 provide[ ] for the use of
nucleic acids encoding an ACT polypeptide; however, since the claims do
not set forth any steps involved in the method/process, it is unclear what
method/process applicant is intending to encompass” (Ans. 12). The
Examiner finds that a “claim is indefinite where it merely recites a use
without any active, positive steps delimiting how this use is actually
practiced. Furthermore, the „metes and bounds‟ of the elected diagnostic
method are unclear since „use‟ does not proscribe [sic] the screening steps
that are within the scope of the invention” (Ans. 12).
Appellants contend that “the person skilled in the art would
understand what is claimed, including the diagnostic uses of the nucleic acid
encoding SEQ ID NO: 3, upon review of the specification.” (App. Br. 12).
Appellants “submit, in view of the specific nucleic acid sequence set forth in
the claims and the specific uses for which they are employed together with
the common knowledge how they are employed to perform these uses and
the skill in the art, that the rejected claims meet these requirements” (App.
Br. 12).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner‟s conclusion that claims 5-13 are indefinite?
Findings of Fact
5. Claim 5 has no active steps other than “providing a nucleic
acid” and “using said nucleic acid”.
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Principles of Law
A claim is indefinite if, when read in light of the specification, it does
not reasonably apprise those skilled in the art of the scope of the invention.
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir.
2003) (citations omitted).
During prosecution of an application before the USPTO, the threshold
standard of ambiguity for indefiniteness is lower than it might be during
litigation of an issued patent. Ex parte Miyazaki, 89 USPQ2d 1207, 1212
(BPAI 2008) (precedential). “[I]f a claim is amenable to two or more
plausible claim constructions, the USPTO is justified in requiring the
applicant to more precisely define the metes and bounds of the claimed
invention by holding the claim . . . indefinite.” Id. at 1211.
Analysis
The Examiner finds that a “claim is indefinite where it merely recites
a use without any active, positive steps delimiting how this use is actually
practiced” (Ans. 12). We agree. Claim 5 details no steps which explain how
the diagnosis, treatment and/or prevention of the specified wounds would be
performed by “using” a nucleic acid of SEQ ID NO: 3, nor does claim 5
detail any steps for the production of a pharmaceutical for treatment or
prevention by “using” the same nucleic acid. “Providing” a nucleic acid, the
only other active step recited in claim 5, does not result in any of the
outcomes recited in claim 5. Without such positive steps, the ordinary
artisan cannot determine which diagnosis, treatment, prevention or
pharmaceutical production methods are encompassed by the claims. See Ex
parte Erlich, 3 USPQ2d 1011,1017 (Bd. Pat. App. & Int. 1986) (“While …
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the claims need not recite all of the operating details, we do find that a
method claim should at least recite a positive, active step(s) so that the claim
will „set out and circumscribe a particular area with a reasonable degree of
precision and particularity,‟ and make it clear what subject matter [the]
claims encompass, as well as making clear the subject matter from which
others would be precluded.”) (citations omitted.)
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that
claims 5-13 are indefinite.
C. 35 U.S.C. § 251 for lack of defect or error
In the instant case, Appellants stated that the error was that “the
submission of linking claims, which are broad enough to read on or link the
invention elected with the invention not elected, was omitted. Although
Applicant/Patentee reserves the right to present additional, different
broadening claims in connection with this application, new independent
claims 5 and 12 have been presented which recite a scope which is broader
in certain respects than originally issued independent claim 1” (Reissue Dec.
1, Aug. 13, 2010).
As discussed above, we conclude that claims 5-13 are indefinite
because speculation is required to determine the meaning of the terms
employed and assumptions are required as to the intended scope of the
claims. Because the scope of the claims is unclear, it is also unclear whether
the claims are properly interpreted as linking claims, as argued by
Appellants, or whether the claims simply represent an attempt to avoid the
copendency requirement of 35 U.S.C. § 120.
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We therefore do not reach the merits of the Examiner‟s rejection of
claims 5-13 under 35 U.S.C. § 251 since the claims cannot be properly
interpreted. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (holding that
the Examiner and the Board were wrong in relying on what, at best, were
speculative assumptions as to the meaning of the claims and in basing a
prior-art rejection thereon). The reasoning in In re Steele is reasonably
applicable to the appealed rejections under 35 U.S.C. § 251 because
reaching a decision regarding this issue requires that we first determine
whether the claims are properly understood as linking claims or instead as
simple joinder of multiple, patentably distinct inventions.
D. 35 U.S.C. § 112, first paragraph, scope of enablement
As discussed above, claims 5-13 are indefinite because speculation is
required to determine the meaning of the terms employed and assumptions
are required as to the intended scope of the claims. Because the scope of the
claims is unclear, it is also unclear what claim scope must be enabled in
order to satisfy 35 U.S.C. § 112, first paragraph. We therefore do not reach
the merits of the Examiner‟s rejection of claims 5-13 under 35 U.S.C. § 112,
first paragraph, for lack of enablement. See In re Steele, 305 F.2d at 862
(holding that the Examiner and the Board were wrong in relying on what, at
best, were speculative assumptions as to the meaning of the claims and in
basing a prior-art rejection thereon). The reasoning in In re Steele is
applicable to rejections under 35 U.S.C. § 112, first paragraph, for
enablement because reaching decisions regarding these issues requires that
we first understand the metes and bounds of the claims.

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SUMMARY
In summary, we affirm the rejection of claim 5 under 35 U.S.C. § 251
as being an improper recapture of broadened claimed subject matter
surrendered in the application for the patent upon which the present reissue
is based. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii), we also affirm the
rejection of claims 6-13 as these claims were not argued separately. We
reverse this ground of rejection as applied to originally issued claims 1-4.
We affirm the rejection of claim 5 under 35 U.S.C. § 112, second
paragraph, as indefinite. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii), we also
affirm the rejection of claims 6-13 as these claims were not argued
separately.
We do not reach the rejection of claims 5-13 under 35 U.S.C. § 251,
first paragraph, as being an improper recapture of broadened claimed subject
matter surrendered in the application for the patent upon which the present
reissue is based.
We do not reach the rejection of claims 5-13 under 35 U.S.C. § 112,
first paragraph, as failing to reasonably provide enablement for the full
scope of the instant claims.

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-IN-PART

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