Ex Parte Doshi

Patent Trial and Appeal Board

Jan 30, 2013

12075695 (P.T.A.B. Jan. 30, 2013)

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.
12/075,695 03/12/2008 Tulsee Satish Doshi P 1141.28009 3707
7590 01/31/2013
Richard A. Wilhelm
PO Box 171
Marylhurst, OR 97036
EXAMINER
MARTIN, PAUL C
ART UNIT PAPER NUMBER
1653
MAIL DATE DELIVERY MODE
01/31/2013 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 TULSEE SATISH DOSHI
__________

Appeal 2011-013499
Application 12/075,695
Technology Center 1600
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for detecting exposure to a first ionizing radiation and a method for
inferring a likelihood of exposure to ionizing radiation. The Patent
Examiner rejected the claims as failing to comply with the enablement
requirement. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
Claims 1-11 are on appeal. Claims 1 and 9 are representative and read
as follows:

1. A method for detecting exposure to first ionizing radiation,
comprising:

performing a first HbA1c test on blood extracted from an animal at a
first time, to establish a baseline glycosylated hemoglobin score;

performing a second HbA1c test on blood extracted from said animal at a
second time subsequent to said first time, to establish a test glycosylated
hemoglobin score;

comparing said test score to said baseline score and to determine a
difference therebetween; and

inferring whether the animal has or has not been exposed to the first ionizing
radiation between said first and second times based at least in part on the
amount of said difference.

9. A method for inferring a likelihood of exposure to ionizing radiation,
comprising:

determining a baseline glycosylated hemoglobin score by performing a first
HbAlc test on blood extracted from an animal at a first time;

determining a test glycosylated hemoglobin score by performing a second
HbA1c test on blood extracted from said animal at a second time subsequent
to said first time;

determining a difference between said test score and said baseline score by
comparing said test score to said baseline score;

quantifying the amount of ionizing radiation received by said animal by
comparing said difference between said test score and said baseline score to
a radiation exposure function relating radiation dosage to HbA1c score,
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wherein said radiation exposure function relates radiation dosage to changes
in HbA1c score and increases in HbA1c score positively correlate with
increases in radiation dosage; and

inferring a likelihood of exposure to ionizing radiation between said first and
second times based at least in part on said quantified amount of ionizing
radiation.

The Examiner rejected claims 1-11 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.

ENABLEMENT
The Examiner’s position is the Specification would not have enabled a
person of ordinary skill in the art to practice the claimed invention without
undue experimentation. (Ans. 6.) Specifically, the Examiner found that the
quantity of experimentation to perform the claimed methods would be undue
because the person of ordinary skill in the art would first have to correlate in
vivo levels of HbA1c in all possible test subjects with a change caused by
exposure to every type of ionizing radiation to the exclusion of all other
factors of HbA1c fluctuation. (Id.) According to the Examiner, this
experimentation would require determining normal HbA1c levels for every
type of animal, including humans, determining the response of every said
animal to every form of ionizing radiation; determining all sources of
variability of glycosylated hemoglobin levels in these animals; and
determining how to predict the effects thereof and/or control for these
outside factors. (Id. at 7.)
The Examiner also found that the Specification did not provide
sufficient direction or guidance to a skilled artisan as to how to differentiate
a change in HbA1c scores caused by exposure to ionizing radiation to the
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exclusion of changes caused by other factors. (Id.) For example, the
Examiner found that HbA1c levels can vary seasonally, with age, between
human smokers and non-smokers, and in response to a menopausal
condition. (Id.)(citing Simon at 864, 866). Additionally, the Examiner
found that it was well known in the art that HbA1c levels are used to
diagnose diabetes, which can manifest as an increase in glycosylated
hemoglobin over normal values. (Id.)(citing Spec. [0013]). Further, the
Examiner found that exposure to gamma rays, x-rays, and radium causes
hemolysis of human blood erythrocytes and blood, which leads to a decrease
in glycosylated hemoglobin. (Id.)(citing Kollmann 551, ll. 24-25).
According to the Examiner, a skilled artisan would expect that the levels of
glycosylated hemoglobin in a subject could be affected by these factors apart
from, or in addition to, exposure to ionizing radiation. (Id.)
The Examiner also found that the Specification does not provide any
evidence of a correlation between actual exposure to ionizing radiation in an
animal with a concurrent change in its HbA1c levels. (Id.) In particular, the
Examiner found that the examples in the Specification are not drawn to in
vivo assays of subjects exposed to ionizing radiation. (Id. at 8.) Rather, the
Specification examples are drawn to in vitro isolated blood samples place in
proximity to an x-ray machine. (Id.) According to the Examiner, these
exampled do not support an inference of whether an animal has been
exposed to ionizing radiation because a skilled artisan would have
recognized that the in vitro assay could not necessarily be correlated to an in
vivo assay involving a more complex whole organism- especially in view of
known variables potentially affecting glycosylated hemoglobin. (Id.)
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The Examiner found that the nature of the invention involves
performing HbA1c tests on blood extracted from an animal twice,
comparing the results of two tests, and inferring whether or not the animal
has or has not been exposed to ionizing radiation between the first and
second tests. The Examiner found that significant unpredictability exists
with respect to the use of HbA1c levels to infer whether an animal has or has
not been exposed to ionizing radiation due to the many art-recognized
sources known to cause variability in glycosylated hemoglobin levels. (Id.
at 10.)
The Examiner found that in addition to encompassing all animals, the
breadth of the claims is also unlimited with respect to the time period
between the performance of the first and second HbA1c tests, which is
significant because the Specification discloses that all red blood cells die by
about 120 days. (Id. at 11.) Additionally, the Examiner found that claims
were broader than the sole example in the Specification which involved a
time period of only one hour between the performance of the first and
second HbA1c tests. (Id. at 12.)
Regarding claims 1-8, Appellant contends that “the specification and
figure as originally filed fully complies with the enablement requirement
because one of ordinary skill in the art would be able to practice the
recitations of claim 1 based on the disclosure of the specification without
undue or unreasonable experimentation.” (App. Br. 12-13.) Appellant
asserts that Specification “Figure 1 plainly shows a change in HbA1c score
as a function of radiation exposure.” (Id. at 13.) Therefore, according to
Appellant, “a person of ordinary skill in the art would know how to perform
the first and second HbA1c tests,” and further “be able to infer from a small
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difference or no difference that the person was not exposed to ionizing
radiation or would be able to infer, at least in part, from a large difference
that the person was exposed to ionizing radiation.” (Id.) Appellant asserts
that “[a]ny experimentation required to determine which differences may
appropriately be considered ‘small’ or ‘large’ for a particular embodiment
would be routine.” (Id.)
Regarding claims 9-11, Appellant contends that “the specification and
figure as originally filed fully complies with the enablement requirement
because one of ordinary skill in the art would be able to practice the
recitations of claim 1 [sic] based on the disclosure of the specification
without undue or unreasonable experimentation.” (Id. at 16.) Appellant
asserts that with regard to the recitation in claim 9 of “quantifying an amount
of ionizing radiation received by said animal,” the Specification states
“where the photon energy of the ionizing radiation is known and a radiation
function is constructed utilizing data corresponding to the same photon
energy, direct comparison can be made to infer dosage.” (Id. at 17.) With
regard to the step of “inferring a likelihood of exposure to ionizing radiation
between said first and second times based at least in part on said quantified
amount of ionizing radiation,” Appellant asserts that Figure 1 plainly shows
a change in HbA1c score as a function of radiation exposure. (Id.)
Analysis
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.”’ In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993); In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991). Factors to
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consider include “(1) the quantity of experimentation necessary, (2) the
amount of direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state of the prior
art, (6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the claims.” In re Wands,
858 F.2d 731, 737 (Fed. Cir. 1988).
When rejecting a claim under the enablement 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 by
the description of the invention provided in the specification of
the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the
scope of enablement. If the PTO meets this burden, the burden
then shifts to the applicant to provide suitable proofs indicating
that the specification is indeed enabling.

Wright, 999 F.2d at 1561-62.
We agree with the Examiner that the Specification would not have
enabled a person of ordinary skill in the art to practice the claimed invention
without undue experimentation. (Ans. 5-13.) The Examiner set forth in the
Answer a reasonable factual basis for why the claims are not enabled, and
Appellant has not presented persuasive arguments, supported by sufficient
facts, indicating otherwise. (See App. Br. 12-20; Reply Br. 5-26.)
In particular, the Examiner found that the quantity of experimentation
that a skilled artisan would need to undertake to perform the “inferring” step
of the claims would be undue, as the artisan would need to first correlate in
vivo levels of HbA1c in all possible test subjects with a change caused by
exposure to every type of ionizing radiation, to the exclusion of all other
factors potentially causing HbA1c fluctuations. (Ans. 6.) The artisan
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would also need to determine all sources potential variations in glycosylated
hemoglobin levels in animals and further determine how to predict the
effects of these sources and/or control for these outside factors. (Id.)
Additionally, the Examiner found that the Specification did not provide
direction or guidance to one of ordinary skill in the art as to how to
differentiate a change in HbA1c scores caused by exposure to ionizing
radiation to the exclusion of other factors. (Id.) The Examiner provided
evidence that HbA1c levels can vary seasonally, with age, according to
smoking status, based upon menopausal status, and the existence of a
diabetic condition. (Id.) Such variability also indicates the unpredictability
of relying on a change in the HbA1c level as a basis for detecting exposure
to ionizing radiation.
In response, Appellant does not challenge the Examiner’s finding that
factors such as smoking, menopausal status, diabetes, age, and seasonality
may affect HbA1c levels. Rather, Appellant asserts that “[c]laims 1 and 9
recite that an inference is made regarding exposure to radiation at least in
part on the amount of difference between the first and second blood tests.”
(Reply Br. 5.) In other words, Appellant acknowledges that variables exist
that may cause a change between the firs and second blood tests. However,
according to Appellant, if any of these factors is present in an animal, “the
factor would presumably have the same influence on both the first and
second blood tests.” (Id. at 5-6.) However, Appellant has not provided any
evidence to support this presumption.
Further, Appellant asserts, “if the animal stops smoking, develops
diabetes, reaches menopause, or ages by many years, then one of ordinary
skill would understand that the part of difference between the first and
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second blood tests may be increased or decreased from the case where none
of the factors changes for the individual,” in which case “the test is less
helpful.” (Id. at 6.) Appellant refers to paragraph [0023] of the
Specification, which states in part, “it may be desired to supplement the
HbA1c test with other standard blood tests, other tests on the animal, to
confirm the cause of the change in score.” (Id.) However, this guidance is
vague, as it does not disclose when such “standard blood tests” should be
used in combination with the claimed method, or how their results should be
factored into the claimed “inferring” step.
In response to the Examiner’s finding that the Specification does not
provide sufficient guidance, Appellant asserts that “[t]he claims do not
require … differentiating changes in HbA1c levels caused by other factors
from changes in HbA1c levels caused by exposure to ionizing radiation” nor
do the claims “require prediction and correction for other factors that may
cause a change in HbA1c level.” (Reply Br. 8.) However, we agree with the
Examiner that the step of inferring whether the animal has or has not been
exposed to ionizing radiation, and the step of inferring a likelihood of
exposure to ionizing radiation, based at least in part on the amount of the
difference in first and second HbA1c tests necessarily requires consideration
and correction of other factors that could influence or cause such difference.
After considering all of the evidence and arguments, we conclude that
the Examiner set forth a reasonable explanation as to why the scope of
protection provided by the claimed methods is not adequately enabled by the
description of the invention provided in the Specification. On rebuttal,
Appellant has not provided sufficient evidence (see, e.g., Reply Br. 18-26) to
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overcome the conclusion of non-enablement. See Wright, 999 F.2d at 1561-
62.

SUMMARY
We affirm the rejection of claims 1-11 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.

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

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