Ex Parte Klimberg et al

Patent Trial and Appeal Board

Nov 21, 2016

11332702 (P.T.A.B. Nov. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111332,702 01/13/2006
7590
Benjamin Aaron Adler
ADLER & AS SOCIA TES
8011 Candle Lane
Houston, TX 77071
11/21/2016
FIRST NAMED INVENTOR
Suzanne Klimberg
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.
D6602 4517
EXAMINER
NEGIN, RUSSELL SCOTT
ART UNIT PAPER NUMBER
1631
MAILDATE DELIVERY MODE
11/21/2016 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 SUZANNE KLIMBERG and LARRY SUV A
Appeal2014-009712
Application 11/332,702
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN and
KRISTI L. R. SA WERT, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
identifying protein patterns that are diagnostic for breast cancer. The
Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse the
Examiner's obviousness rejection. Pursuant to 37 C.F.R. § 41.50(b),
however, we enter a new ground of rejection under 35 U.S.C. § 101.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's rejection of
claims 1 and 4, under 35 U.S.C. § 103(a), for obviousness over Morris, 1
1 WO 98/35229 Al (published Aug. 13, 1998).
Appeal2014-009712
Application 11/332,702
Zwick,2 and Hitt3 (Final Action 4--9). 4
Claims 1 and 4 are on appeal and read as follows (Br. 12-13):
Claim 1 : A method of identifying protein pattern( s) that is
diagnostic for breast cancer in an individual, comprising the steps of:
obtaining a tear sample from an individual with breast cancer;
acquiring protein profile data during surface-enhanced laser
desorption/ionization time-of-flight mass spectrometry performed on
said individual's tear sample and on a control tear sample, said
acquired data optimized for protein molecular weights in the range of
about 1 kDa to about 40 kDa;
comparing the acquired protein profile in said individual's tear
sample with the acquired protein profile of said control tear sample to
detect proteins that are differentially present in said individual's tear
sample with respect to said control tear sample; and
indicating that said individual has an increased risk of having
breast cancer compared to said control,
wherein pattern( s) comprising the protein profile containing at
least one protein that displays a peak at
a mass-to-charge ratio of about 35,000 of statistically greater
intensity than the corresponding peak in said control tear sample;
a mass-to-charge ratio within the range of 6,000 to 7 ,000 of
statistically greater intensity than the corresponding peak in said
control tear sample; or
a mass-to-charge ratio within the range of 3,750 to 6,000 of
statistically lesser intensity than the corresponding peak in said
control tear sample,
or a combination thereof;
wherein the presence of said peak( s) is diagnostic for at least a
risk of having breast cancer.
Claim 4: The method of claim 1, wherein said control sample is
from a healthy individual.
2 US 2004/0033613 Al (published Feb. 19, 2004).
3 US 2003/0004402 Al (published Jan. 2, 2003).
4 Final Action entered June 14, 2013.
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Appeal2014-009712
Application 11/332,702
OBVIOUSNESS
The Examiner cited Morris as describing a method of diagnosing
diseases, including breast cancer, by analyzing the proteins present in tears.
Final Action 5. The Examiner found that Morris differs from Appellants'
claim 1 in a number of respects, including in that Morris does not use the
surface-enhanced laser desorption/ionization time-of-flight mass
spectrometry ("SELDI-TOF") technique required by claim 1 to analyze its
tear samples. Id. at 6.
To address that deficiency, the Examiner cited Zwick as using
SELDI-TOF in protein profiling methods in which the protein profile in a
test sample, which may be saliva, is compared to a control sample from a
different individual, thereby diagnosing diseases, including breast cancer.
Id. The Examiner found that Figure 3 of Zwick, displaying data from cancer
patients, exhibited at least one peak having a mass-to-charge ratio meeting
claim 1 's requirement of detecting a peak having a mass-to-charge ratio of
about 35,000, the detected peak having a statistically greater intensity than
the corresponding peak in a control sample. Id. at 7.
The Examiner cited Hitt as evidence that SELDI-TOF was known in
the art to be a suitable technique for generating data from biological
samples, including from saliva and tears. Id.
Based on the references' teachings, the Examiner concluded that it
would have been obvious to use SELDI-TOF in the analytical methods
taught by Morris, and to compare the SELDI-TOF profile from a tear sample
from a healthy control to an individual with cancer. Id. at 8-9.
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Appeal2014-009712
Application 11/332,702
As stated in In re Oetiker, 977F.2d1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Appellants argue, among other things, that "the data reported by
Zwick et al. based on SELDI-TOF analysis of saliva does not teach any of
three specific peaks required by Applicant's claims." Br. 9.
The Examiner responds that "Figure 3 of Zwick teaches mass to
charge ratios of ABOUT 35,000." Ans. 2.
We find that Appellants have the better position.
Claim 1 requires comparing (a) the SELDI-TOF protein profile
obtained from a tear sample of an individual with breast cancer to (b) the
SELDI-TOF protein profile obtained from a control tear sample obtained
from another individual, "to detect proteins that are differentially present in
[the breast cancer] individual's tear sample with respect to [the] control tear
sample." Br. 12. The difference in protein profiles "indicat[es] that said
individual has an increased risk of having breast cancer compared to said
control." Id.
Claim 1 requires the protein profile from the individual with breast
cancer to display at least one protein at a statistically greater intensity than
the corresponding peak from the control tear sample. Id. Among those
differentially detected proteins, claim 1 includes a protein with a mass-to-
charge ratio of about 35,000. Id.
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Application 11/332,702
The Examiner does not persuade us that Figure 3 of Zwick displays a
protein with a mass-to-charge ratio of about 35,000 of statistically greater
intensity than the corresponding peak in other samples shown in the Figure.
As the Examiner notes, Figure 3 of Zwick shows SELDI-TOF spectra from
8 cancer patients, "4 class I and 4 class II." Zwick i-f 18.
At best, however, the highest values shown in Figure 3 of Zwick are
about 25,000. See Zwick Fig. 3. Thus, not only does Figure 3 not show any
peaks at 35,000, the highest possible peak Figure 3 might show has a mass
to charge ratio about 10,000 less than 35,000. Because the Examiner does
not identify specifically which peaks allegedly meet the requirement in
claim 1, and because the highest possible peak shown in Figure 3 differs by
nearly one-third from the value recited in claim 1, the Examiner does not
persuade us that Zwick's Figure 3 shows a peak encompassed by claim 1.
We recognize that claim 1 uses the term "about 35,000" to describe
the detected peak. Br. 9.
As our reviewing court has explained, "use of the word 'about,'
avoids a strict numerical boundary to the specified parameter." Ortho-
McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd.,
476 F.3d 1321, 1326 (Fed. Cir. 2007).
However, "the word 'about' does not have a universal meaning in
patent claims[;]" rather, "the meaning depends on the technological facts of
the particular case." Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211,
1217 (Fed. Cir. 1995); see also Eiselstein v. Frank, 52 F.3d 1035, 1039 (Fed.
Cir. 1995) ("The meaning of the word 'about' is dependent on the facts of
the case, the nature of the invention, and the knowledge imparted by the
totality of the ... disclosure to those skilled in the art.").
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Application 11/332,702
Thus, in evaluating the scope of "about," it is appropriate to look to
how the Specification and other claims use the term, as well as considering
the effects of varying the parameter described by the term. Pall Corp., 66
F.3d at 1217.
In the instant case, the Examiner does not explain persuasively why a
skilled person in this art, viewing the totality of Appellants' disclosure,
would consider the term "about" to encompass a value that differs by nearly
one-third from the claim-recited value. Given that Figure 3 of Zwick shows
many different peaks within a span of 10,000, the Examiner does not
persuade us that varying the mass-to-charge ratio by 10,000 would be
insignificant. To the contrary, if "about" encompassed a range of plus or
minus 10,000 as the Examiner seems to posit, most of the peaks shown in
Zwick's Figure 3 would be effectively indistinguishable.
In sum, because we are not persuaded, for the reasons discussed, that
the Examiner has explained persuasively why the cited combination of
Morris, Zwick, and Hitt teaches or suggests all of the features required by
claim 1, we reverse the Examiner's rejection of that claim, and its dependent
claim 4, over those references.
NEW GROUND OF REJECTION
Under the provisions of 37 C.F.R. § 41.50(b ), we enter the following
new ground of rejection:
Claims 1 and 4 are rejected under 35 U.S.C. § 101 as being directed to
non-statutory subject matter.
At the outset, we note that the Examiner withdrew a rejection of
claims 1 and 4 for non-statutory subject matter under § 101. Final Action 2.
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Application 11/332,702
For the reasons discussed below, however, we conclude that it was not
appropriate to withdraw that rejection.
35 U.S.C. § 101 states that "[w]hoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title."
The Supreme Court has "long held that this provision contains an
important implicit exception: Laws of nature, natural phenomena, and
abstract ideas are not patentable." Alice Corp. Pty. Ltd. v. CLS Bank Intern.,
134 S.Ct. 2347, 2354 (2014).
In Mayo Collaborative Services v. Prometheus Labs, Inc., 132 S.Ct.
1289 (2012), the Supreme Court held ineligible under§ 101 claims directed
to a process of optimizing the efficacy of a drug treatment. In particular, the
claims recited administering a specific drug to a subject, and determining the
level of a particular metabolite in the subject, with the determined level of
the metabolite indicating whether the amount of the drug should be
increased or decreased. Id. at 1295.
In concluding that the claims were ineligible subject matter under
§ 101, the Court explained in Mayo that "the claims inform a relevant
audience about certain laws of nature; any additional steps consist of well-
understood, routine, conventional activity already engaged in by the
scientific community; and those steps, when viewed as a whole, add nothing
significant beyond the sum of their parts taken separately." Id. at 1298.
In the instant case, like the law of nature in Mayo (the correlation
between the metabolite level and the need for increasing or decreasing the
amount of administered drug), claims 1 and 4 involve the law of nature
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discovered by Appellants, that an increased level in tears of at least one of
the three proteins recited in the claims correlates with an increased
likelihood of having breast cancer. As is seen by the prior art cited by the
Examiner, the steps recited in Appellants' claims-obtaining a tear sample
from a patient with breast cancer to perform protein profiling (see, e.g.,
Morris, abstract and page 2), using SELDI-TOF to acquire a protein profile
from a fluid sample for the purpose of diagnosing diseases such as breast
cancer (see, e.g., Zwick, abstract; id. at i-f 15 (SELDI-TOF); id. at i-f 46
(protein marker diagnostic for breast cancer); id. at i-f 61 (saliva or lachrymal
fluid samples)), and comparing obtained the protein profile to a control
individual (Zwick i-f 15}-were all known in the art to be applied in the type
of analysis involved in Appellants' claims.
As discussed above in relation to the Examiner's obviousness
rejection, the law of nature discovered by Appellants has not been shown on
this record to have been known to those skilled in the art. Nonetheless, as in
Mayo, the remainder of Appellants' claims, beyond that law of nature,
consists of "well-understood, routine, conventional activity already engaged
in by the scientific community." Mayo, 132 S.Ct. at 1298.
Accordingly, because claims 1 and 4 are directed to the law of nature
discovered by Appellants, that an increased level in tears of at least one of
the three proteins recited in the claims correlates with an increased
likelihood of having breast cancer, and because the remaining subject matter
of the claims adds nothing to that natural law, except conventional activity
which the scientific community is already engaged in, claims 1 and 4 are not
directed to patentable subject matter encompassed by 35 U.S.C. § 101. We,
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therefore, enter this rejection of claims 1 and 4 under § 101, for lack of
statutory subject matter.
SUMMARY
For the reasons discussed, we reverse the Examiner's obviousness
rejection and enter a new ground of rejection under 35 U.S.C. § 101.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective Sept. 13, 2004; revised, 76 FR 72270, Nov.
22, 2011, effective Jan. 23, 2012). 37 C.F.R. § 41.50(b) provides "[a] new
ground of rejection pursuant to this paragraph shall not be considered final
for judicial review.
37 C.F.R. § 41.50(b) also provides that 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 proceeding
will be remanded to the examiner ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record ....
REVERSED, 37 C.F.R. § 41.50(b)
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