Ex Parte Patzke

Patent Trial and Appeal Board

Mar 7, 2019

14030143 (P.T.A.B. Mar. 7, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/030,143 09/18/2013
126799 7590 03/11/2019
Dugan & Dugan, PC
245 Saw Mill River Road, Suite 309
Hawthorne, NY 10532
FIRST NAMED INVENTOR
Juergen Patzke
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.
2012Pl5073US (SAG-009) 5934
EXAMINER
MARCSISIN, ELLEN JEAN
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
03/11/2019 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):
Duganemail@duganpatent.com
bdugan@duganpatent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUERGEN PATZKE 1
Appeal2018-004075
Application 14/030, 143
Technology Center 1600
Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method for determining an amount or activity of a platelet-associated analyte
in a sample from an individual. The Examiner rejected the claims as
anticipated and obvious over the prior art, and for obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellant identifies the real party in interest as Siemens Healthcare
Diagnostics Products GmbH. (Br. 2.) Herein we reference the Sept. 18,
2013 Specification ("Spec."); Dec. 9, 2016 Final Office Action ("Final
Action"); Aug. 10, 2017 Appeal Brief ("Br."); and Feb. 7, 2018 Examiner's
Answer ("Answer").
Appeal2018-004075
Application 14/030, 143
STATEMENT OF THE CASE
The Specification states that platelets contain a multiplicity of
intracellular ingredients, which have physiologically important functions in
hemostasis. (Spec. 1-2.) It is, therefore, of diagnostic relevance to identify
deficiencies or dysfunctionalities of platelet-associated analytes (such as
factor XIII and von Willebrand factor) and to identify defects in the release
of said analytes from the platelet granules. (Id. at 2.)
Further, many diagnostically relevant platelet-associated substances
occur not only in the platelets, but also in the plasma. (Id. at 3.) According
to the Specification, it is therefore desirable to determine the concentration
or activity of an analyte not only in a patient's platelets, but also in his or her
plasma. (Id.) Appellant's claims are directed to a method of determining
the difference between the amount or activity of a platelet-associated analyte
in a sample of an individual's platelet-rich plasma versus the amount or
activity of that analyte in a sample of an individual's platelet-poor plasma.
(Id. at 5.)
Claims 1-5, 7, 10, and 11 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A method for determining an amount or an activity of a
platelet-associated analyte in a sample from a single individual,
wherein the method comprises the following steps:
a) providing a first assay volume containing platelet-rich
plasma from the single individual and a detergent,
b) providing a second assay volume containing platelet-
poor plasma from the single individual,
c) measuring an amount or an activity of the analyte in
the first assay volume and measuring an amount or an activity
of the analyte in the second assay volume to determine first and
second measurement results, and
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Application 14/030, 143
d) comparing the first and second measurement results
which includes determining a difference between the first and
second measurement results,
wherein the difference between the first and second
measurement results corresponds to the amount or the activity
of the platelet-associated analyte,
wherein providing the first assay volume includes adding
the detergent and analyte-specific detection reagents to the
platelet-rich plasma without performing any additional
centrifugation or washing before measuring the amount or the
activity of the first assay volume.
(Appeal Br. 12.)
The claims stand rejected as follows:
1. Claims 1-3, 5, 7, and 10 under 35 U.S.C. § 102 as anticipated by
Parsi 2007. 2
2. Claims 1-3, 5, 7, and 10 under 35 U.S.C. § 102 as anticipated by
Parsi 2011. 3
3. Claims 4 and 11 under 35 U.S.C. § I03(a) as obvious over Parsi
2007 or Parsi 2011 and Kappel. 4
4. Claims 1-5, 7, 10, and 11 under 35 U.S.C. § I03(a) as obvious
over Althaus, 5 Kappel, and Parsi 2011.
2 K. Parsi et al., In Vitro Effects of Detergent Sclerosants on Coagulation,
Platelets and Microparticles, 34 Eur. J. Vase. Endovasc. Surg. 731--40
(2007).
3 K. Parsi et al., In Vitro Effects of Detergent Sclerosants on Clot Formation
and Fibrinolysis, 41 Eur. J. Vase. Endovasc. Surg. 267-77 (2011).
4 A. Kappel et al., Fully Automated Immunoassay for Quantitative
Determination of FXIII, 31 (2) Hamostaseologie 105---09 (2011 ).
5 Althaus et al., US 2010/0136589 Al, published June 3, 2010.
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Application 14/030, 143
5. Claims 1-5, 7, 10, and 11 on the ground ofnonstatutory double
patenting over claims 1-21 of US Patent 9,222,942 B2, Kappel,
and Parsi 2011.
ANALYSIS
Anticipation
"Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). Here, the Examiner found that each of
Parsi 2007 and Parsi 2011 discloses all claim limitations, including claim
step ( d), i.e., "comparing the first and second measurement results which
includes determining a difference between the first and second measurement
results." (See, e.g., Final Action 3--4, 5.) With respect to the purported
disclosure of step ( d), the Examiner relied on Parsi 2007 's reporting of
results of analyte activity in platelet-rich plasma ("PRP") and platelet-poor
plasma ("PPP") from a number of individuals (id. at 3--4 ), and on similar
disclosure in Parsi 2011. (Id. at 5.)
Appellant disputes that the Parsi references disclose step ( d). With
respect to Parsi 2007, Appellant argues that the reported results show
"average values of samples of different individuals" (Br. 5), and that
there is no teaching or even suggestion of comparing the
measurement result of a first (PRP) assay volume of one
individual to a second (PPP) assay volume of the same
individual which would allow determination of the amount or
activity of a platelet-associated analyte in the sample of that
particular individual.
(Id.) Similarly, with respect to Parsi 2011, Appellant argues that the error
bars in Fig. 5 "impl[y] that each data point is an average value of more than
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Application 14/030, 143
one sample tested," such that Parsi 2011 "does not disclose comparison of
the measurement results of a first (PRP) and a second (PPP) assay volume of
one individual." (Id. at 6-7.) Appellant further argues that in finding that
the Parsi references disclose claim step ( d), the Examiner "misconstrues
Appellant's claimed feature 'a first assay volume containing platelet-rich
plasma from the single individual' and the feature 'a second assay volume
containing platelet-poor plasma from the single individual' to include assay
volumes that contain plasmas from more than the single individual." (Id. at
8.)
In response, the Examiner does not dispute that the Parsi references
teach average values of samples of different individuals. Instead, the
Examiner asserts that the claim language is "not clearly closed," because the
method steps of providing the first and second assay volumes "containing
platelet rich plasma" do not recite closed transitional language such as
"consisting of platelet-rich plasma." (Answer 16) (emphasis added). As
such, in the Examiner's view, "even a pooled sample contains samples from
an individual." (Id.) Stated differently, it is the Examiner's position that
"the body of the claim fails to recite closed claim language such that would
limit the first and second assay volumes to consisting of only a single
individual's sample." (Id. at 20.)
We disagree with the Examiner's interpretation of the claims.
Although the Examiner is correct that the body of claim 1 is not "closed,"
this does not mean that the claim is open to assay volumes from more than
one individual. The Examiner's interpretation does not account for the
claim's preamble, which recites: "[a] method for determining an amount or
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Application 14/030, 143
an activity of a platelet-associated analyte in a sample from a single
individual." (Br. 12) ( emphasis added). At a minimum, this preamble
provides antecedent basis for the "single individual" language that is twice
recited in body of the claim. As such, the preamble "act[ s] as a necessary
component of the claimed invention," and, so it is a limitation. Eaton Corp.
v. Rockwell Int'! Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003). Here, the
preamble requires that the method is carried out on a sample from a single
individual. Even though the "providing" steps are not closed and can be met
if ingredients over and above PRP or PPP plasma are included in the assay
volumes, this is true only if those ingredients still satisfy the "single
individual" claim language recited in the preamble. Contrary to the
Examiner's assertions, comparing an average of PRP assay results from
multiple individuals to an average of PPP assay results from multiple
individuals does not meet claim step ( d), which requires comparing
measurement results from a single individual. The Examiner does not
contend that the Parsi references compare analyte data from an individual's
PRP sample to analyte data from the same individual's PPP sample, and
indeed we do not see such disclosure in the Parsi references.
The Examiner bears the burden of establishing a prima facie case of
unpatentability. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). On the
record before us, the Examiner has not established a foundational fact on
which each of the Examiner's anticipation rejections rests, i.e., that Parsi's
disclosure of averaged analytical results meets claim step ( d).
Although this finding is dispositive of the anticipation rejections and
requires their reversal, we address Appellant's additional arguments with
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Application 14/030, 143
respect to the Parsi references. As to Parsi 2005, Appellant argues that it
does not disclose the claim step of adding "analyte-specific detection
reagents" to the PRP. (Br. 5.) According to Appellant, "XACT
measurement is not an analyte-specific measurement because it does not
allow determination of an amount or activity of a single analyte, but rather is
primarily dependent on procoagulant phospholipid, factor V, and factor II
(see Table 1)." (Id.) The Examiner responds that "Appellant's claims as
presently recited broadly encompass any platelet-associated analyte and any
analyte-specific detection reagents," and that "Parsi teach[es] the XACT
measurement in order to assess factor Xa clotting time ( assess factor Xa
activity)." (Answer 17.)
We agree with the Examiner. Appellant's claims are not limited to
detection of a single platelet-associated analyte or detection reagent, but
broadly encompass any platelet-associated analyte and any analyte-specific
detection reagents, including more than one analyte or reagent. Further, as
noted by the Examiner, Parsi 2007 teaches that the XACT test is directed to
the activity of factor Xa (see, e.g., Parsi 2007 at Abstract, 732), which
qualifies as a platelet-associated analyte as presently claimed. Although
Table 1 indicates that the activity of factor Xa depends on the activities of
other analytes (procoagulant phospholipid, factor V, and factor II), the
reference teaches that the ultimate use of the XACT test is to determine the
activity of factor Xa. (See id.)
With respect to Parsi 2011, Appellant argues that the discussion of
"similar results" "means that each of PRP and PPP yielded similar results
when compared to the results of WB [ whole blood]," and "does not clearly
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Application 14/030, 143
mean that PRP and PPP results have been compared" to each other. (Br. 6.)
The Examiner responds that "by being able to state results were similar,
Parsi (2011) necessarily made a comparison between the three assay
volumes (WB, PPP and PRP)." (Answer 19.) We do not find Appellant's
argument persuasive. Instead, we agree with the Examiner that Parsi 2011
reports comparing the PRP and PPP fractions not only with whole blood, but
with each other as well, finding that POL had minimal effect on the FXIII
analyte in all three sample types (WB, PPP, and PRP). (Parsi 2011 at 273.)
In view of the above, we reverse the Examiner's rejections of claims
1-3, 5, 7, and 10 as anticipated by Parsi 2007 and by Parsi 2011.
Obviousness
The Examiner's obviousness rejections of claims 1-5, 7, 10, and 11
rely on the Examiner's position that the Parsi references teach claim step ( d).
(Answer 6, 9.) For the reasons set forth above, we disagree with the
Examiner's position that the Parsi references teach claim step (d). Even if
the references teach or suggest collecting PRP and PPP samples from
individuals and ultimately making a comparison of PRP and PPP analytes,
generally, there has been no determination made by the Examiner that
comparisons of any individual's respective samples were or should be
compared to one another. Consequently, we reverse the obviousness
rejections.
We note that after the Final Rejection, the Examiner indicated in a
February 3, 2017 Advisory Action that,
[i]n the interest of compact prosecution, it is noted that if for
any reason it may be desirable to perform the methods as taught
by the prior art on a single individual's sample (i.e. a volume
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Application 14/030, 143
that consists of a single individual's sample) rather than on a
population (pooled volume), a prima facie case of obviousness
may exist.
(Advisory Action 2.) The Examiner notes that she raised a similar issue in a
June 28, 2017 Interview. (See July 10, 2017 Interview Summary, which
states: "[W]hether a sample is assayed as an individual sample or as
multiple individuals, such an amendment still may be insufficient to
overcome rejection under 35 U.S.C. 103(a), indicating for example the prior
art recognized the ability to perform assays on both pooled samples, as well
as samples for a specific individual.") While we agree that the Examiner's
rationale has merit, the Examiner did not make any claim rejections based on
such a rationale, in view of her construction of the claims. In the event of
continued prosecution, the Examiner may wish to further develop a reasoned
analysis as to whether or why a person of ordinary skill in the art would have
been motivated to modify Parsi's methods to compare analyte data from an
individual's PRP sample to analyte data from the same individual's PPP
sample.
Obviousness-Type Double Patenting
On appeal, Appellant does not address the Examiner's obviousness-
type double patenting rejection of claims 1-5, 7, 10, and 11. (See, e.g.,
Appeal Br. 1-11.) Nevertheless, as noted above, the Examiner bears the
burden of establishing a prima facie case of unpatentability. Oetiker, 977
F.2d at 1445. And, like the anticipation and obviousness rejections, the
Examiner's obviousness-type double patenting rejection relies on the
unsupported finding that Parsi 2011 teaches claim step ( d). (Final Action
13; Answer 13.) Thus, we are already apprised of arguments by Appellant
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Application 14/030, 143
concerning the deficiency of the Examiner's anticipation and obviousness
rejections that are equally applicable to the failure of the Examiner's prima
facie case ofunpatentability based on obviousness-type double patenting,
despite Appellant's failure to specifically argue against this rejection.
Although summary affirmance of the rejection is warranted on the
ground that arguments not presented in a brief are waived (see 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015) ("Except as provided for in§§ 41.41, 41.47 and
41.52, any arguments or authorities not included in the appeal brief will be
refused consideration by the Board for purposes of the present appeal.")),
given the record here, we reverse the obviousness-type double patenting
rejection in the interests of justice given that the rejection is based on an
unsupported finding.
SUMMARY
We reverse the rejection of claims 1-3, 5, 7, and 10 under 35 U.S.C.
§ 102 as anticipated by Parsi 2007.
We reverse the rejection of claims 1-3, 5, 7, and 10 under 35 U.S.C.
§ 102 as anticipated by Parsi 2011.
We reverse the rejection of claims 4 and 11 under 35 U.S.C. § 103(a)
as obvious over Parsi 2007 or Parsi 2011 and Kappel.
We reverse the rejection of claims 1-5, 7, 10, and 11 under 35 U.S.C.
§ 103(a) as obvious over Althaus, Kappel, and Parsi 2011.
We reverse the rejection of claims 1-5, 7, 10, and 11 on the ground of
nonstatutory double patenting over claims 1-21 of US Patent 9,222,942 B2,
Kappel, and Parsi 2011.
REVERSED
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