Ex Parte Hansen et al

Patent Trial and Appeal Board

Apr 12, 2016

11664561 (P.T.A.B. Apr. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/664,561 05/01/2008
23650 7590 04/14/2016
NOVO NORDISK INC.
INTELLECTUAL PROPERTY DEPARTMENT
800 Scudders Mill Road
Plainsboro, NJ 08536
FIRST NAMED INVENTOR
Jon Ulrich Hansen
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.
6870.204-US 1697
EXAMINER
CANELLA, KAREN A
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
04/14/2016 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):
nnipatent@novonordisk.com
KISW@novonordisk.com
CELN@novonordisk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JON ULRICH HANSEN, LEIF ENGMANN KRISTENSEN,
JETTE RANDLOV, KNUD POULSEN, RADISCH ULRIK DETLEF
POULSEN, JENS ULRIK POULSEN, JORGEN SMEDEGAARD
KIRSTENSEN, and HANS HENRIK THODBERG 1
Appeal2014-001524
Application 11/664,561
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
Opinion for the Board filed by
SCHNEIDER, Administrative Patent Judge.
Opinion Dissenting filed by
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving a claim to self-
monitoring of insulin administration, which has been rejected as anticipated
and as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
1 Appellants identify the Real Party in Interest as Novo Nordisk A/S.
Appeal Br. 4.
Appeal2014-001524
Application 11/664,561
We reverse.
STATEMENT OF THE CASE
The invention related to self-care of diabetes using electronic data
analysis. Spec. 1. Data is collected about a user's actions and the data is
then used to detect a user habit. Based on the user's habit, reminders are
generated to alert the user to take action such as administer insulin. Spec. 2.
Claim 1 is on appeal and reads as follows:
1. A method of assisting a user in the self-
management of diabetes, the method comprising
- obtaining data about occurrences of at least a first
type of user actions;
- detecting a user habit from the obtained data; and
- generating a reminder data item from the detected
user habit, and
- storing the generated reminder data item in a
device to be carried by the user said device is one
of a blood glucose measuring device and an insulin
administration device,
\~1herein detecting a user habit comprises
determining a distribution of occurrences of said
first type of user actions over a predetermined
period of time and detecting a time interval during
which said first type of user actions typically
occurs.
Claim 1 stands rejected as follows:
Claim 1 is rejected under 35 U.S.C. § 102(b) as being anticipated by
Jones et al. (US 6,650,951 Bl, issued Nov. 18, 2003) (Jones).
Claim 1 is rejected under 35 U.S.C. § 103(a) as being obvious over
Jones et al. in view of Werner et al. (US 6,425,863 Bl, issued Jul. 30, 2002)
(Werner).
2
Appeal2014-001524
Application 11/664,561
Issue
I
The Examiner has rejected claim 1 as being anticipated by Jones. The
Examiner finds that Jones discloses obtaining data about occurrences of a
user action and detecting a user habit in that Jones teaches obtaining data
concerning mealtimes directly from the user. Ans. 3. The Examiner finds
that Jones further teaches storing the data into a device and then issuing a
warning which meets the limitation of generating a reminder from the stored
habit information. Id.
Appellants contend that, as used in the claims, the term "occurrences"
relates to an action that occurred in the past and that Jones relates to future
events; thus, Jones does not obtain data about occurrences. Appellants
further argue that Jones does not teach detecting a user habit from the data
obtained about occurrences. Appeal Br. 8-9.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that Claim 1 is anticipated
by the teachings of Jones as defined by 35 U.S.C. § 102(b).
Findings of Fact
FF 1. Jones relates to a method and system for providing a forgotten
bolus warning to an insulin pump user. Jones, col. 1, 11. 8-10.
FF2. Jones teaches that the user inputs prospective mealtimes for a
given week and a wait period into a memory device. Jones, col. 3, 11. 34--53.
FF3. Jones teaches that the wait time is then added to the mealtime.
Jones, col. 3, 11. 62-63.
3
Appeal2014-001524
Application 11/664,561
FF4. Jones teaches that an alert is given if no insulin has been given
before the expiration of the meal time plus the wait time. Jones, col. 3, 1.
66-col. 4, 1. 7.
Principles of Law
"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).
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"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." Id.
"If an applicant had to prove novelty before he could obtain a patent
he would have an almost insurmountable burden. Therefore, the statute
provides for what may be said to be a presumption of novelty in the
language of section 102 'a person shall be entitled to a patent unless---'
(Emphasis added). What this means, in an ex parte proceeding to obtain a
patent, is that the Patent Office has the initial burden of coming forward with
some sort of evidence tending to disprove novelty." In re Wilder, 429 F.2d
447, 450 (CCPA 1970).
Analysis
Appellants have argued that Jones does not teach the limitations of
obtaining data regarding occurrences and detecting a user habit from the
4
Appeal2014-001524
Application 11/664,561
obtained data. Appeal Br. 8-9. While we disagree with respect to the
limitation of obtaining data about occurrences, we agree that Jones fails to
teach the limitation of detecting a user habit from the obtained data. Jones
teaches gathering data about prospective mealtimes. FF2. This is data
regarding occurrences as called for in claim 1. That the occurrence is in the
future is irrelevant as the term "occurrences" in claim 1 is not limited to past
events.
The Examiner, however, has not pointed to a description in Jones of
detecting a user habit from the obtained data. The Examiner cites Jones'
disclosure of user-inputted mealtime data, along with user defined wait time,
to create an alert if insulin is not administered before the expiration of
mealtime plus wait time. FF3--4. The Examiner has not pointed to anything
in Jones which teaches detecting a user habit from the obtained data. Thus,
the Examiner has failed to come forward with evidence tending to disprove
novelty. In re Wilder, 429 F.2d at 450.
The Examiner's arguments have been considered but are deemed
unpersuasive. Again, the Examiner has not pointed to any disclosure in
Jones to suggest that the mealtimes are derived from occurrences and in fact
Jones provides default mealtimes and wait times if not data is entered by the
user. Jones col. 3, 11. 54--57.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that claim 1 is anticipated by the teachings of
Jones as defined by 35 U.S.C. § 102(b).
5
Appeal2014-001524
Application 11/664,561
II
Issue
The Examiner has rejected claim 1 under 35 U.S.C. § 103(a) as
obvious over Jones in view of Werner. The Examiner finds that
Ans. 4--5.
[i]t would have been prima facie obvious at the
time that the claimed invention was made to apply
the method of WERNER et al within the method
of JONES et al such that more or less insulin units
are administered as a result of the detected user
habit of using a prior insulin dose per bread unit
after a meal. One of skill in the art would have
been motivated to do so []by the teachings of
JONES et al. regarding the need to minimize high
blood sugar excursions after a meal (column 1,
lines 35-39), and the teachings of WERNER et al
regarding the aim of insulin treatment to
compensate for the influence of a meal on blood
sugar level such that normal blood sugar is
maintained (column 4, lines 10-13). One of skill
in the art would understand that an output unit
such as the display or monitor used by WERNER
et al could be used by the method of JONES et al
to display both the visual reminder to administer
the insulin bolus and the amount of insulin to be
administered in light of the analysis of data
according to the method of WERNER.
Appellants contend that the combination of Jones and W em er fails to
teach all of the elements of claim 1, specifically the limitation of detecting a
user habit from the obtained data. Appeal Br. 10. Appellants also argue that
there is insufficient motivation to combine the references and that one
skilled in the art would not have a reasonable expectation of success.
Appeal Br. 11-12.
6
Appeal2014-001524
Application 11/664,561
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that Jones in combination
with Werner renders the claimed method obvious within the meaning of 35
U.S.C. § 103(a).
Findings of Fact
FF5. Werner is directed to a method for enabling a diabetic patient to
observe the influence meals and insulin doses have on blood sugar levels.
Werner, col. 2, 11. 16-18.
FF6. Werner teaches the plotting of blood sugar differences before
and after meals versus the ratio of bread units to insulin taken to show the
effect meals and insulin have on blood sugar. Werner, col. 3, 11. 55---65.
FF7. Werner teaches using the plot to train the user to more
effectively calculate the amount of insulin needed after a given meal.
Werner, col. 6, 11. 56---60.
Principles of Law
A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teaching of the
prior art." In re Ochiai, 71F.3d1565, 1572 (Fed. Cir. 1995).
"The Patent and Trademark Office (PTO) must consider all claim
limitations when determining patentability of an invention over the prior
art." In re Lowry, 32 F.3d 1579, 1582 (Fed. Cir. 1994).
An invention
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently,
known in the prior art. Although common sense directs one to
look with care at a patent application that claims as innovation
7
Appeal2014-001524
Application 11/664,561
the combination of two known devices according to their
established functions, it can be important to identify a reason
that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed
new invention does.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
When a prima facie case of obviousness has not been established, the
rejection must be reversed. In re Fine, 837 F.2d 1071, 1075 (Fed. Cir.
1988).
Analysis
Appellants argue that the combination of Jones and Werner fail to
teach all of the limitations of claim 1, specifically the limitation calling for
detecting a user habit from the obtained data. App. Br. 10. We agree with
Appellants. As discussed above, Jones is silent about detecting a user habit,
and Werner is similarly deficient. Werner discloses plotting blood sugar
changes versus bread unit/insulin ratios to show the effect meals and insulin
have on blood sugar levels. FF5. This is accomplished by taking the
difference in blood sugar levels after a meal and comparing that difference
with the ratio of bread units consumed during a meal versus units of insulin
administered after a meal. FF6. The data is then used to educate the user
about the need to more accurately calculate the amount in insulin needed
after a given meal. This is not the same a detecting a user habit from data
obtained about occurrences or events that have occurred or will occur. Thus
the combined references fail to teach all the limitations of claim 1 and a
prima facie case of obviousness has not been made. In re Lowery, 32 F.3d at
1582.
8
Appeal2014-001524
Application 11/664,561
From the foregoing it is clear that Examiner has failed to establish a
prima facie case of obviousness. Therefore we reverse the rejection. In re
Fine, 837 F.2d at 1075.
Conclusion of Law
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that Jones in view of Werner render claim 1
obvious within the meaning of 35 U.S.C. § 103(a).
SUMMARY
We reverse the rejection of claim 1.
REVERSED
9
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JON ULRICH HANSEN, LEIF ENGMANN KRISTENSEN,
JETTE RANDLOV, KNUD POULSEN, RADISCH ULRIK DETLEF
POULSEN, JENS ULRIK POULSEN, JORGEN SMEDEGAARD
KIRSTENSEN, and HANS HENRIK THODBERG2
Appeal2014-001524
Application 11/664,561
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge, dissenting.
I respectfully dissent from the Majority's opinion reversing the
rejection of claim 1 as anticipated by Jones. In my view, the Majority has
arrived at an incorrect result in this case by failing to properly interpret the
scope of claim 1.
Findings of Fact
FF8. The Specification teaches that "a diabetic maintains a log of
various parameters that are relevant and give an insight into his/her living
habits and present state of health. For example, apart from recording blood
2 Appellants identify the Real Party in Interest as Novo Nordisk A/S.
Appeal Br. 4.
Appeal2014-001524
Application 11/664,561
glucose readings, insulin intakes etc., the amount of meals/carbohydrates
consumed, exercise done/calories burnt ... may also be recorded" (Spec. 10,
11. 8-11 ).
FF9. The Specification teaches that "[i]n some embodiments, the
patient enters the collected data onto a self-management device" (Spec. 10,
11. 22-24).
FF 10. The Specification teaches that in "some embodiments, the
habit detection is performed fully automatic, while in other embodiments,
the habit detection may involve different degrees of user interaction, e.g. by
providing functionality that allows a user to point out habits in the presented
reports" (Spec. 11, 11. 14--17).
FFl 1. The Specification teaches that "[i]t is understood that the habit
detection may also be performed interactively, i.e. allowing a user to control
the detection .... The habits may then be manually detected by the diabetic
or HCP" (Spec. 18, 11. 5-9).
FF12. The Specification teaches "a habit detector function, which is
able to detect meal time" (Spec. 17, 11. 29-30).
FF 13. Jones teaches "method and apparatus for providing a forgotten
bolus warning for an insulin pump user" (Jones, col. 1, 11. 50-52).
FF14. Jones teaches that the "user has the capability of programming
expected mealtimes by day of the week and a time duration or wait period
starting at the expected eating time" (Jones, col. 2, 11. 56-59).
FF15. Jones teaches that the "user programs expected mealtimes that
can be different on a daily basis or on a weekday and a weekend basis"
(Jones, col. 2, 11. 61---63).
2
Appeal2014-001524
Application 11/664,561
FF16. Jones teaches that the "user is prompted for a time period to
wait before a warning is issued if no bolus were administered after the
expected mealtime has passed" (Jones, col. 2, 11. 63---65).
FFl 7. Jones teaches that "each of the wait periods for issuing a
warning can be set independently. Such independent wait periods can be
advantageous because perhaps evening mealtimes might not be quite as
predictable as breakfast or lunch mealtimes" (Jones, col. 3, 11. 1-5; emphasis
added).
FF18. Jones teaches that "a warning wait period can be stored with
each mealtime stored" (Jones, col. 3, 11. 41--42).
Principles of Law
It is black letter law that "the PTO gives a disputed claim term its
broadest reasonable interpretation during patent prosecution" In re Bigio,
381F.3d1320, 1324 (Fed. Cir. 2004). The Federal Circuit recognized the
fairness of reading claims broadly "before a patent is granted [since] the
claims are readily amended as part of the examination process." Burlington
Indus., Inc. v. Quigg, 822 F.2d 1581, 1583 (Fed. Cir. 1987). "Thus, a patent
applicant has the opportunity and responsibility to remove any ambiguity in
claim term meaning by amending the application." Bigio, 381 F.3d at 1324.
Applying the broadest reasonable interpretation to claims also "serves the
public interest by reducing the possibility that claims, finally allowed, will
be given broader scope than is justified." In re Am. Acad. of Sci. Tech. Ctr.,
367 F.3d 1359, 1364 (Fed.Cir.2004).
Analysis
I begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitations at
3
Appeal2014-001524
Application 11/664,561
issue are "obtaining data about occurrences" and "detecting a user habit
from the obtained data" (see App. Br. 8-9).
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first tum to the
Specification to determine whether the meaning of the phrases "obtaining
data about occurrences", "detecting a user habit from the obtained data", and
"distribution of occurrences ... over a predetermined period of time" can be
discerned.
The Specification teaches that "obtaining data" encompasses
information manually provided by a user that "give an insight into his/her
living habits" (FF8). There is no specific time requirement in claim 1 for the
"obtaining data" step, nor does claim 1 read in light of the Specification
impose an automation requirement (FF9). Instead, any information about
"living habits" including preferred mealtimes obtained by thoughtful
reflection by a user regarding the "predictability" of their mealtimes (FF 17)
represents data that may be obtained to satisfy the limitation of "obtaining
data about occurrences of at least a first type of user actions" consistent with
claim 1.
The Specification teaches that "detecting a user habit" "may involve
different degrees of user interaction" (FFlO) including "allowing a user to
control the detection" (FF 11 ). Thus, the limitation "detecting a user habit
from the obtained data" also does not require automation, and reasonably
encompasses the determination by a user of whether a mealtime is at a
"predictable" time or not (FF 1 7).
4
Appeal2014-001524
Application 11/664,561
Lastly, the Specification teaches that one habit that may be detected is
"mealtime" (FF 12).
I would therefore interpret claim 1 to encompass the situation where a
user, aware of data regarding their ordinary mealtimes, "detects" those
"predictable" (FF 17) mealtimes and inputs those "predictable" mealtimes
into a device in order to generate reminders or other information as further
required by claim 1.
Applying this interpretation to the prior art, Jones teaches
management of diabetes (FF13) by obtaining data about mealtime
occurrences (FF14) and "allowing a user to control the detection" by
entering expected mealtime information (FF15). Jones teaches to generate
reminder data for the mealtimes (FF 16), to store that data in the insulin
administration device (FF18). Lastly, Jones teaches to address a
"distribution of occurrences" of the mealtimes by setting different reminders
depending upon the meal "because perhaps evening mealtimes might not be
quite as predictable as breakfast or lunch mealtimes" (FFl 7). This is an
express suggestion that the user has detected a habit, specifically regarding
the predictability of breakfast or lunch mealtimes.
I recognize, but find unpersuasive, Appellants' argument that
"'Occurrences' is bolded because Appellant's wish to point out it refers to
something that has happened in the past" (App. Br. 8). There is nothing
in the Specification or claim that requires the occurrences to represent
actions in the past rather than actions planned for the future.
I recognize, but find unpersuasive, Appellants' argument that "JONES
does not disclose or suggest 'detecting a user habit' because the user habit in
5
Appeal2014-001524
Application 11/664,561
JONES is not detected from the obtained data. On the contrary (proposed or
expected) mealtimes must be manually entered" (App. Br. 9).
Claim 1, when properly interpreted, does not require automatic
detection of user habits. Rather, claim 1 encompasses the situation where a
user, in entering the user's ordinary mealtimes, necessarily also "detects a
user habit" for particular mealtimes. Indeed, Jones recognizes that perhaps
evening mealtimes might not be quite as predictable as breakfast or lunch
mealtimes, and the use of the term "predictable" is an express teaching of a
habit that is "predictable" and that was detected manually by a user based on
the data obtained by the user regarding their mealtime preferences.
The Majority succumbs to this fallacious argument, finding that
"There is nothing in Jones that teaches analyzing the data inputted by the
user to detect a habit" (Maj. Opinion 4). However, Jones expressly teaches
that "perhaps evening mealtimes might not be quite as predictable as
breakfast or lunch mealtimes" (FF 17). The word "predictable" expressly
recognizes that the user has analyzed the data regarding their mealtimes and
recognized habitual breakfast and lunch mealtimes (FF 17).
For these reasons, I respectfully dissent.
6