Ex Parte Wang et al

Patent Trial and Appeal Board

Feb 22, 2016

12950142 (P.T.A.B. Feb. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/950,142 11/19/2010
23557 7590 02/24/2016
SALIW ANCHIK, LLOYD & EISENSCHENK
A PROFESSIONAL ASSOCIATION
PO Box 142950
GAINESVILLE, FL 32614
FIRST NAMED INVENTOR
KA-WANG (KEVIN) WANG
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.
UF.532XTDCD1 7150
EXAMINER
CHERNYSHEV, OLGAN
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
02/24/2016 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):
euspto@slepatents.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KA-WANG (KEVIN) WANG, MING-CHENG LIU, and
MONIKAOLI 1
Appeal2013-004462
Application 12/950,142
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and RICHARD J. SMITH,
Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 of claims to a method of
detecting a trauma induced brain injury. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 According to Appellants, the real party in interest is University of Florida
Research Foundation, Inc. (Appeal Br. 1.)
Appeal2013-004462
Application 12/950,142
STATEMENT OF THE CASE
Claims on Appeal
Claims 15, 16, 18, and 25-33 are on appeal. 2 (Appeal Br. 12-14.)
Claim 15 is illustrative and reads as follows:
15. A method of detecting a trauma induced brain injury in a subject
compnsmg:
collecting a first biological sample from an injured subject suspected
of having the trauma induced brain injury;
measuring said sample, or a portion of the sample, for an amount of
ubiquitin C-terminal hydrolase LI (UCH-Ll) associated with the trauma
induced brain injury;
optionally measuring said sample, or a portion of the sample, for at
least one additional protein biomarker associated with the trauma induced
brain injury;
comparing said amount ofUCH-Ll in an injured subject with an
amount of the biomarker in an uninjured subject;
wherein an increased amount of the UCH-L 1 from said injured
subject, as compared with the uninjured subject, is indicative of the trauma
induced brain injury in said injured subject.
Examiner's Rejections
Claims 15, 16, and 25-33 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement. (Ans. 3.)
Claims 18 stands rejected under 35 U.S.C. § 112, second paragraph,
as indefinite. (Ans. 2.)
Findings of Fact
FF 1. The Specification teaches that
In a preferred embodiment, detection of at least one neural
protein in CSP, 3 blood, or other biological fluids, is diagnostic of
2 Claims 1-14, 17, and 19-24 are cancelled. (Appeal Br. 1.)
3 CSP refers to cerebral spinal fluid or cerebrospinal fluid. (Appeal Br. 10.)
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Appeal2013-004462
Application 12/950,142
the severity of brain mJury and/or the monitoring of the
progression of therapy. Preferably, the neural proteins are
detected during the early stages of injury. An increase in the
amount of neural proteins, fragments or derivatives thereof, in a
patient suffering from a neural injury, neuronal disorder as
compared to a normal healthy individual, will be diagnostic of a
neural injury and/or neuronal disorder.
(Spec. 37, 11. 10-15.)
FF 2. The Specification teaches that
Preferably, the samples comprise neural cells, for example, a
biopsy of a central nervous system or peripheral nervous system
tissue are suitable biological samples for use in the invention. In
addition, after injury to the nervous system (such as brain injury),
the neural cell membrane is compromised, leading to the efflux
of these neural proteins first into the extracellular fluid or space
and to the cerebrospinal fluid and eventually in the circulating
blood (as assisted by the compromised blood brain barrier) and
other biofluids (e.g. urine, sweat, [] saliva, etc.). Thus, other
suitable biological samples include, but not limited to such cells
or fluid secreted from these cells. Obtaining biological fluids
such as cerebrospinal fluid, blood, plasma, serum, saliva and
urine, from a subject is typically much less invasive and
traumatizing than obtaining a solid tissue biopsy sample. Thus,
samples, which are biological fluids, are preferred for use in the
invention. CSP, in particular, is preferred for detecting nerve
damage in a subject as it is in immediate contact with the nervous
system and is readily obtainable.
(Id. at 42, 11. 9-20.)
FF 3. The Examiner finds that "[t]he specification discloses [a] series of
experiments which measure levels ofUCH-Ll in CSP and blood samples of
patients suffering from traumatic brain injury (TBI) and similar
measurements in rats under experimental TBI." (Ans. 4.)
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Appeal2013-004462
Application 12/950,142
FF 4. The Examiner finds that the Specification is "enabling for a method
of determining the presence of traumatic brain injury (TBI) in a subject by
measuring [the] amount ofUCH-Ll in CSP or blood sample obtained from a
subject wherein the elevated levels of UCH-Ll measured within seven days
from the TBI are diagnostic for TBI." (Id. at 3.)
FF 5. The Examiner "does not dispute that it is fully within the grasp of a
skilled worker to perform the steps of obtaining any biological sample from
the subject under diagnosis and measuring the levels ofUCH-Ll without
any experimentation." (Id. at 7.)
FF 6. The Examiner "fully agrees that the steps of measuring protein levels
can be performed using any biological sample." (Id. at 10.)
DISCUSSION
Enablement
Issue
Whether the evidence of record supports the Examiner's conclusion
that the claimed invention fails to satisfy the enablement requirement.
Principles of Law
Enablement requires that the specification teach those in the art to
make and use the invention without "undue experimentation." In re Vaeck,
947 F.2d 488, 495 (Fed. Cir. 1991) (quoting Jn re f'Vands~ 858 F.2d 731, 737
(Fed. Cir. 1988)). Furthermore, "[ w]hen rejecting a c1aim under the
enab1ement requirement of section 112, the PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled." In re Wright,
999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
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Application 12/950,142
Analysis
The Examiner states that "the specification fails to enable one in the
art to practice the claimed invention with a sample obtained from other than
CSP or blood because it fails to demonstrate an established correlation
between the presence of a brain injury in a subject and an increase in the
amount of UCH-L 1 in a sample obtained from other than CSP or blood, such
as sputum, urine, skin or hair." (Ans. 3.) Furthermore, the Examiner states
that "the claimed method of diagnosis - detecting increased levels of UCH-
L 1 in any sample in a subject and at any time after the occurrence of the
injury- clearly lacks enablement, as disclosed." (Id. at 6.)
Appellants argue that "the Examiner has not articulated any specific
reason as to why the skilled artisan could not readily, and without undue
experimentation, conduct the claimed assay, with a reasonable expectation
of success, using any of a variety of biological samples." (Appeal Br. 6.) In
addition, Appellants submit several articles that "provide evidence that
detection of protein biomarkers in various biological fluids, such as blood,
CSP, and urine, is routine." (Id.) Appellants also submit a Declaration4
stating that "one may reasonably expect to detect an analyte, such as an
antigen or antibody, in the various biological fluids disclosed in the current
specification." (Deel. i-f 5.) Finally, Appellants provide an analysis of the
Wands factors in support of their argument of enablement. (Appeal Br. 7-
9.); see TVands, 858 F.2d at 737.
\Ve are persuaded by Appellants' arguments. The Examiner has
failed to meet the initial burden of setting forth a reasonable explanation as
4 Declaration of Ka-Wang (Kevin) Wang under 37 C.F.R. § 1.132, dated
September 7, 2011.
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Appeal2013-004462
Application 12/950,142
to why the claimed scope of protection is not adequately enabled. See
Wright, 999 F.2d at 1561-62. A specification need not "necessarily describe
how to make and use every possible variant of the claimed invention, for the
artisan's knowledge of the prior art and routine experimentation can often
fill gaps, interpolate between embodiments, and perhaps even extrapolate
beyond the disclosed embodiments, depending upon the predictability of the
art." AK Steel Corp. v. Sollac and Ugine, 344 F.3d 1234, 1244 (Fed. Cir.
2003). Moreover, the Examiner~s findings acknowledge enablement for at
least sorne modes of the claims, including the preferred use of CSF for the
biological smnp1e. (FF 4.) It is well settled that "[t]he enablement
requirement is met if the description enables any mode of making and using
the invention." Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1361
(Fed. Cir. 1998) (quoting Engel Indus., Inc. v. Lodiformer Co., 946 F.2d
1528, 1533 (Fed. Cir. 1991)).
Accordingly, the rejection based on lack of enablement is reversed.
Conclusion
The evidence of record fails to support the Examiner's conclusion that
claims 15, 16, and 25-33 fail to satisfy the enablement requirement. The
rejection under the enablement requirement of 35 U.S.C. § 112, first
paragraph, is reversed.
Indefiniteness
Issue
Whether a preponderance of evidence of record supports the
Examiner's conclusion that claim 18 is indefinite under 35 U.S.C. § 112,
second paragraph.
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Application 12/950,142
Analysis
The Examiner's indefiniteness rejection states
Claim 18 recites the limitation "at a time point after said
first biological sample is drawn and indicative of trauma induced
brain injury". It is not obvious what is indicative of trauma
induced brain injury- the patient, the time point, the biological
sample? Clarification is required.
Further, it appears that claim 18 is written to encompass
monitoring the progress/recovery after trauma induced brain
injury; however, claim 18 depends from claim 15, which states
the goal of the process as a diagnostic method only - detecting
trauma induced brain injury, thus making claim 18 indefinite for
lack of antecedent basis of the recited step and stated preamble.
(Ans. 2.)
Appellants' Appeal Brief makes no substantive argument in response
to the rejection, arguing only that claim 18 "is clear and definite to those
skilled in the art [and] ... has proper antecedent basis." (Appeal Br. 11.) In
the Reply Brief, Appellants state that "an amendment to claim 18 was
submitted[] consistent with the Examiner's suggestions [] However, the
Examiner failed to enter the Amendment."5 (Reply Br. 4.)
We find the Examiner has established a prima facie case of
indefiniteness under 35 U.S.C. § 112, second paragraph. Moreover, in the
absence of any substantive argument pointing out any alleged error in the
Examiner's rejection, the rejection is affirmed. See Ex Parte Frye, 94
USPQ2d 1072, 1075 (BPAI 2010) (precedential) (citing cases). Also, the
Examiner's refusal to enter an amendment after final is a matter addressed
by a petition, not an appeal to the Board. Id. at 1078 (citing In re Mindick,
371F.2d892, 894 (CCPA 1967)).
5 See Amendment Under 37 C.F.R. § 1.116, filed February 21, 2012.
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Application 12/950,142
Conclusion
A preponderance of evidence of record supports the Examiner's
conclusion that claim 18 is indefinite under 35 U.S.C. § 112, second
paragraph.
SUMMARY
We reverse the Examiner's rejection of claims 15, 16, and 25-33
under 35 U.S.C. § 112, first paragraph, as failing to comply with the
enablement requirement.
We affirm the Examiner's rejection of claim 18 under 35 U.S.C.
§ 112, second paragraph.
TIME PERIOD FOR RESPONSE
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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