Ex Parte Aykroyd et al

Patent Trial and Appeal Board

Aug 23, 2018

14039762 (P.T.A.B. Aug. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/039,762 09/27/2013
98067 7590 08/27/2018
Harness Dickey & Pierce (Roche)
5445 Corporate Drive, Suite 200
Troy, MI 48098-2683
FIRST NAMED INVENTOR
Timothy N. Aykroyd
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.
31739 US (15878A-139) 3805
EXAMINER
HOLCOMB, MARK
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
08/27/2018 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):
rmills@hdp.com
pair_roche@firsttofile.com
troymailroom@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY N. A YKROYD, AMY C. DAY, PAUL J. GALLEY,
SEBASTIAAN LA BASITIDE, CHRISTEN A. REES, and
NIGEL A. SURRIDGE
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Application 14/039,762
Technology Center 3600
Before ST. JOHN COURTENAY III, JASON J. CHUNG, and
SCOTT B. HOWARD, Administrative Patent Judges.
COURTENAY, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from a final rejection of
claims 1-20, which are all the claims pending in this application. We have
jurisdiction over the pending claims under 35 U.S.C. § 6(b ).
We affirm.
1 According to Appellants, the real party in interest is Roche Diabetes Care,
Inc. App. Br. 3.
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STATEMENT OF THE CASE
Introduction
Appellants' invention "relates to handheld medical devices and more
particularly to systems and methods for analyzing a user's risk of
hypoglycemia and hyperglycemia." (Spec. ,r 1 ).
Exemplary Claim
1. A handheld diabetes management device for assessing a
patient's risk of future hypoglycemia, the handheld
diabetes management device comprising:
a blood glucose (bG) measurement engine that
selectively measures bG levels in blood samples input to the
handheld diabetes management device;
a display;
a clock tracking a current date and time;
a processor; and
a computer readable medium including code executed by
the processor to:
identify a period ofN days, the period including the
current date and N-1 days immediately prior to the
current date, wherein N is an integer greater than 6;
determine a total number of the N days during which the
patient input at least two blood samples to the handheld
diabetes management device; and
in response to a determination that the total number of
the N days is greater than M, M being an integer greater
than zero and less than or equal to N:
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calculate a value based on the bG levels of blood
samples input to the handheld diabetes management
device during the period;
based on the value, classify the patient as having a first,
second, or third risk of being hypoglycemic in the future,
the second risk being greater than the first risk, and the
third risk being greater than the second risk; and
display the classification of the patient's risk of being
hypoglycemic on the display.
App. Br. 25 (Emphasis added to contested limitations).
Rejections
A. Claims 18 and 19 are rejected under 35 U.S.C. § 112(b), as being
indefinite for failing to particularly point out and distinctly claim the
subject matter that the inventors regard as the invention. Final
Act. 3.
B. Claims 1-20 are rejected under 35 U.S.C. § 101 as being directed to
patent-ineligible subject matter. Final Act. 4---6.
C. Claims 1-20 are rejected under§ 103 as being obvious over
Kovatchev et al. (US 8,538,703 B2; Sept. 17, 2013), hereinafter
"Kovatchev." Final Act. 7-13.
Grouping of Claims
Claims 1, 12, and 20 are independent claims. Based upon Appellants'
arguments, we decide the appeal of rejection C under § 103 of claims 1-20
on the basis of representative independent claim 1. We address rejections A
and B, infra. See 37 C.F.R. § 4I.37(c)(l)(iv) (2012).
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Issues on Appeal
A. Did the Examiner err in rejecting claims 18 and 19 under
35 U.S.C. § 112(b ), as being indefinite?
B. Did the Examiner err in rejecting claims 1-20 under 35 U.S.C. § 101,
as being directed to patent-ineligible subject matter?
C. Did the Examiner err in rejecting claims 1-20 under
35 U.S.C. § 103, as being obvious over Kovatchev?
ANALYSIS
We have considered all of Appellants' arguments and any evidence
presented. To the extent Appellants have not advanced separate, substantive
arguments for particular claims, or other issues, such arguments are waived.
See 37 C.F.R. § 4I.37(c)(l)(iv). We highlight and address specific findings
and arguments for emphasis in our analysis below.
Rejection A under 35 USC§ l 12(b)
If there is not explicit antecedent basis for a limitation in the claim the
scope of the claim may still be definite, "[i]f the scope of a claim would be
reasonably ascertainable by those skilled in the art, then the claim is not
indefinite." Energizer Holdings Inc. vs. Int'! Trade Comm 'n., 435 F.3d
1366, 1370-71 (Fed. Cir. 2006) (quoting Bose Corp. v. JBL, Inc., 274 F.3d
1354, 1359 (Fed. Cir. 2001)). Antecedent basis can be present by
implication. Slinifold Mfg. Co.,. v. Kinkead Indus., Inc., 810 F.2d 1113,
1116 (Fed. Cir. 1987).
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Applying the guidance of our reviewing court here, we note claim 18
(which depends directly from independent claim 12) recites in pertinent part:
"18. The method of claim 12 wherein calculating the value includes."
(Emphasis added).
Because claim 18 recites "calculating the value," we conclude, by
implication, the antecedent basis recited in independent claim 12 is:
"calculating a low blood glucose index (LBGI) value." We note claim 19
depends upon claim 18.
Therefore, we reverse the Examiner's Rejection A of claims 18 and
19, under 35 U.S.C. § 112(b ), for essentially the same reasons argued by
Appellants in the Appeal Brief (13), as further discussed above.
Mayo/Alice Analysis under 35 USC§ 101
Under 35 U.S.C. § 101, a patent may be obtained for "any new and
useful process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof." 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 Bankint'l, 134 S. Ct. 2347, 2354 (2014) (quotingAss'nfor
Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)).
The Supreme Court in Alice reiterated the two-step framework previously
set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc.,
566 U.S. 66, 82-84 (2012), "for distinguishing patents that claim laws of
nature, natural phenomena, and abstract ideas from those that claim patent-
eligible applications of those concepts." Alice, 134 S. Ct. at 2355.
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The first step in that analysis is to determine whether the claims at
issue are directed to one of those patent-ineligible concepts, such as an
abstract idea. Abstract ideas may include, but are not limited to,
fundamental economic practices, methods of organizing human activities, an
idea of itself, and mathematical formulas or relationships. Id. at 2355-57.
If the claims are not directed to a patent-ineligible concept, the inquiry
ends. See Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253, 1262 (Fed.
Cir. 2017).
Otherwise, the inquiry proceeds to the second step in which the
elements of the claims are considered "individually and 'as an ordered
combination' to determine whether the additional elements 'transform the
nature of the claim' into a patent-eligible application." Alice, at 2355
(quoting Mayo, 566 U.S. at 79, 78). We consider the question of whether
the claims are directed to a specific improvement in the capabilities of the
computing devices, or, instead, "a process that qualifies as an 'abstract idea'
for which computers are invoked merely as a tool." Enfzsh, LLC v.
Microsoft Corp., 822 F.3d 1327, 1336 (Fed. Cir. 2016).
We, therefore, decide under step two whether the claims: (a) set forth
an inventive concept that provides a specific means or method that improves
the relevant technology, or (b) are directed to a result or effect that itself is
the abstract idea, in which the claims merely invoke generic processes and
machinery. See Enfzsh, 822 F.3d at 1336.
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The Examiner's Rejection under 35 US.C. § 101
Regarding the first step of the Alice/Mayo analysis, the Examiner
concludes claims 1-20 are directed to an abstract idea: 2
The claims are directed to a series of steps or an apparatus
related to determining blood glucose (bG) values based on
blood samples input, tracking a current date and time,
identifying a period of N days, the period including the current
date and N-1 days immediately prior to the current date,
wherein N is an integer greater than 6, determining a total
number of the N days during which the patient input at least
two blood samples and in response to a determination that the
total number of the N days is greater than M, M being an
integer greater than zero and less than or equal to N: calculating
a low blood glucose index (LBGI) value based on the bG
values, based on the LBGI value, classifying the patient as
having a risk of being hypoglycemic in the future, and
displaying the classification of the patient's risk of being
hypoglycemic, which merely comprises the abstract ideas of
comparing new and stored information (new and stored sample
data) and using rules to identify options ( algorithms
determining the patient's risk based on sample [data]); and/or
organizing information through mathematical correlations
(calculating a patient's risk based on equations utilizing
sampled blood glucose levels).
Final Act. 4.
Regarding the second step of the Mayo/Alice analysis, the Examiner
finds the claims do not include additional elements that are sufficient to
amount to significantly more than the judicial exception,
because the additional elements or combination of elements in
the claims, other than the abstract idea per se, amount to no
more than a recitation of[:]
2 "Patent eligibility under§ 101 presents an issue of law." Accenture Glob.
Servs., GmbH v. Guidewire Software, Inc., 728 F.3d 1336, 1340 (Fed. Cir.
2013).
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A) generic computer structure that serves to perform generic
computer functions that serve to merely link the abstract idea to
a particular technological environment (i.e.[,] the Pre-Grant
Publication of Applicant's specification discloses the following
material ( at the corresponding paragraphs) to be composed of
conventional hardware: handheld diabetes management device
(29-37), measurement engine (37-39), display (36), clock (39),
processor ( 40), computer readable medium ( 41 ),
communication module ( 40), mobile device (32-33).); and
B) functions that are well-understood, routine, and
conventional activities previously known to the pertinent
industry (i.e.[,] measuring, tracking, executing, identifying,
determining, calculating, classifying, displaying and
transmitting data); and
C) insignificant extra solution activity that merely represents a
data input (i.e., the blood samples input to a measurement
device).
Final Act. 5 ( emphasis added). 3
For the aforementioned reasons, the Examiner concludes that all
claims 1-20 on appeal are not patent-eligible under 35 U.S.C. § 101.
Mayo/Alice Analysis - Step 1
Regarding Alice Step 1, Appellants recite the language of claim 1
(App. Br. 13-14), and contend: "the Examiner's abstraction ignores the
actual claim limitations. For example, claim 1 is directed to a physical
device and recites a plurality of tangible structural items including a
3 The patent eligibility inquiry may contain underlying issues of fact.
Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1325
(Fed. Cir. 2016). In particular, "[t]he question of whether a claim element or
combination of elements is well-understood, routine and conventional to a
skilled artisan in the relevant field is a question of fact." Berkheimer v. HP
Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018).
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processor, a display, a bG measurement engine, a computer readable
medium." App. Br. 14.
However, we find Appellants' argument pertaining to statutory
subject classes (machine, manufacture) is misplaced, because the
Examiner's rejection under§ 101 is based upon a patent-ineligible judicial
exception - an abstract idea.
Appellants quote Enfzsh, 822 F.3d at 1335, in support of the argument
that the claims on appeal are not directed to an abstract idea ("Software can
make non-abstract improvements to computer technology just as hardware
improvements can, and sometimes the improvements can be accomplished
through either route."). App. Br. 15.
Our reviewing court found Enfish 's invention was an "improvement
of an existing technology" that, unlike conventional relational and object-
oriented databases, did not require a programmer to predefine a structure to
which subsequent data entry must conform. Enfzsh, at 1337.
However, we find Appellants' claims are clearly distinguished from
the claims the court found were not abstract in Enfzsh, 822 F.3d at 1336,
because Appellants' claims are silent regarding any mention of a database,
much less a "self-referential table" that "is a specific type of data structure
designed to improve the way a computer stores and retrieves data in
memory." Enfish, at 1339. Further, McRO, Inc. v. Bandai Namco Games
America Inc., 837 F.3d 1299, 1312 (2016) guides: "The abstract idea
exception prevents patenting a result where 'it matters not by what process
or machinery the result is accomplished."' ( quoting O'Reilly v. Morse, 56
U.S. 62, 113 (1854)) (Emphasis added.).
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Here, we find each of Appellants' independent claims 1, 12, and 20 is
directed to the result of "display[ing] the classification of the patient's risk
of being hypoglycemic on the display." Claim 1, see also commensurate
language of similar scope as recited in claims 12 and 20.
Moreover, we conclude the claims in the present case are analogous to
the claims in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (holding that an
algorithm for calculating parameters indicating an abnormal condition in an
individual is an abstract idea). Similar to Grams, the claims in the present
case are directed to detecting abnormal conditions in the blood glucose
levels.
Appellants provide no further substantive arguments regarding Alice
Step 1. App. Br. 5-7. Arguments not made are waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv). Therefore, we proceed to Alice Step 2.
Mayo/Alice Analysis-Step 2
Because we conclude the claims are directed to an abstract idea for
essentially the same reasons articulated by the Examiner (Final Act. 4 ), we
tum to the second part of the Alice/Mayo analysis. We analyze the claims to
determine if there are additional limitations that individually, or as an
ordered combination, ensure the claims amount to "significantly more" than
the abstract idea. Alice, at 2357.
Regarding Alice Step 2, Appellants address the purported inventive
concept of the claims:
claim 1 of the present application when viewed as a whole
amounts to significantly more than any alleged abstract idea(s).
In claim 1, a bG measurement engine measures bG levels in
blood samples input to the handheld diabetes management
device. When specified criteria are satisfied, the processor of
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claim 1 calculates a value based on bG levels (provided by the
bG measurement engine), uses the value calculated based on the
bG levels to classify the patient as having one of three risks of
future hypoglycemia, and displays the classification on the
display.
App. Br. 17.
In support, Appellants cite to DDR Holdings, LLC v Hotels.com, LP,
773 F3d 1245 (Fed Cir 2014) (holding that claims directed to e-commerce
on the computer using the Internet recite patent eligible subject matter).
App. Br. 18.
In light of DDR Holdings, Appellants urge:
Claim 1 similarly does not merely recite the performance of
business practice known from the pre-Internet world along with
the requirement to perform it on the Internet. In fact, there is
no pre-Internet analogy to claim 1, and the features of claim 1
were not previously performed by computing devices or humans
pre-Internet. This is exemplified further below with respect to
the rejection under 35 USC§ 103.
App. Br. 19 (Emphasis added).
However, the Supreme Court guides: "[t]he 'novelty' of any element
or steps in a process, or even of the process itself, is of no relevance in
determining whether the subject matter of a claim falls within the § 101
categories of possibly patentable subject matter." Diehr, 450 U.S. at 188-89
( emphasis added). Our reviewing court further emphasizes that "[ e ]ligibility
and novelty are separate inquiries." Two-Way Media Ltd. v. Comcast Cable
Commc 'ns, LLC, 874 F.3d 1329, 1340 (Fed. Cir. 2017); see also Affinity
Labs of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253, 1263 (Fed. Cir. 2016)
(holding that "even assuming" that a particular claimed feature was novel
does not "avoid the problem of abstractness").
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We do not find that Appellants' claims are similar to the claimed
solution the court held to be patent-eligible in DDR. In DDR, the Federal
Circuit applied the Supreme Court's Alice two-step framework, and upheld
the validity of DDR's patent on its web-page display technology. DDR, 773
F.3d at 1255.
The problem addressed by Appellants' claims is not similar or
otherwise analogous to the specific technical problem addressed by the
subject claims in DDR, which were directed to retaining a website visitor
when the visitor clicked on a third-party merchant's advertisement on the
host website. Instead of taking the visitor to the third-party merchant's
website (and thus losing the visitor to the third-party merchant), DDR's
claimed system generated a hybrid web page that: (1) displayed product
information from the third-party merchant, but also, (2) retained the host
website's "look and feel."
Here, Appellants' claims 1-20 are not directed to a website that
retains the host website's "look and feel" while displaying product
information from the third-party merchant, as was the case in DDR, at 1257.
Although Appellants' invention is directed to the result of "display[ ing] the
classification of the patient's risk of being hypoglycemic on the display"
( claim 1 ), we find the classification of the patient's risk of being
hypoglycemic is at best merely an improvement in the informational content
(i.e., data) that is intended to be viewed and evaluated by a person as a
mental step.
We find the claims on appeal are silent regarding specific limitations
directed to an improved computer system, processor, memory, network,
database, or Internet. Therefore, we find Appellants' claimed invention does
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not provide a solution "necessarily rooted in computer technology in order to
overcome a problem specifically arising in the realm of computer networks,"
as considered by the court in DDR, 773 F.3d at 1257. (Emphasis added.).
Further regarding the use of the recited generic "processor" ( claim 1 ),
the Supreme Court held "the mere recitation of a generic computer cannot
transform a patent-ineligible abstract idea into a patent-eligible invention."
Alice, at 2358; see also Bascom Glob. Internet Servs., Inc. v. AT&T Mobility
LLC, 827 F.3d 1341, 1348 (Fed. Cir. 2016) ("An abstract idea on 'an
Internet computer network' or on a generic computer is still an abstract
idea.").
Our reviewing court has "repeatedly held that such invocations of
computers and networks that are not even arguably inventive are
'insufficient to pass the test of an inventive concept in the application' of an
abstract idea." Elec. Power Grp., LLC, v. Alstom S. A.1.. 830 F.3d 1350, 1355
(Fed. Cir. 2016) (internal citations omitted); see also Intellectual Ventures I
LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1341 (Fed. Cir. 2017)
("Rather, the claims recite both a generic computer element-a processor-
and a series of generic computer 'components' that merely restate their
individual functions . . . . That is to say, they merely describe the functions
of the abstract idea itself, without particularity. This is simply not enough
under step two.").
Because none of Appellants' claims on appeal is directed to an
improvement in a processor, database, or other computer/network
component, we conclude that none of the claim limitations, viewed both
individually and as an ordered combination, amounts to significantly more
than the judicial exception in order to sufficiently transform the nature of the
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claims into patent-eligible subject matter.
Applying the aforementioned guidance from our reviewing courts to
the claims before us on appeal, we conclude, in our Mayol Alice analysis, that
each of Appellants' claims 1-20, considered as a whole, is directed to (under
step one), a patent-ineligible abstract idea, and under step two, does not
recite something "significantly more" (Alice, at 2357 (internal citation and
quotations omitted)) to transform the nature of the claim into a patent-
eligible application.
Accordingly, for at least these reasons, we sustain the Examiner's
rejection B under 35 U.S.C. § 101 of claims 1-20, as being directed to
patent-ineligible subject matter in light of Alice and its progeny. 4
Rejection C of Independent Claim 1 under§ 103
Issues: Under 35 U.S.C. § 103, did the Examiner err by finding that
Kovatchev would have taught or suggested the contested limitations of:
in response to a determination that the total number of
the N days is greater than M, M being an integer greater
than zero and less than or equal to N:
calculate a value based on the bG levels of blood
samples input to the handheld diabetes management
device during the period;
based on the value, classify the patient as having a first,
second, or third risk of being hypoglycemic in the future,
the second risk being greater than the first risk, and the
third risk being greater than the second risk; and
4 To the extent Appellants have not advanced separate, substantive
arguments for particular claims, or other issues, such arguments are waived.
See 37 C.F.R. § 4I.37(c)(l)(iv).
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display the classification of the patient's risk of being
hypoglycemic on the display [,].
within the meaning of representative independent claim 1 ?5 (Emphasis
added).
Appellants assert the aforementioned emphasized claim limitations
are not taught nor rendered obvious by Kovatchev:
With respect to claim 1, Kovatchev does not teach or
render obvious a handheld diabetes management device that in
response to a determination that the total number ( of days
during which the patient input at least two blood samples to the
handheld diabetes management device during the last N day
period) is greater than M: (a) calculates a value based on the
bG levels of blood samples input to the handheld diabetes
management device during the period; (b) based on the value,
classifies the patient as having a first, second, or third risk of
being hypoglycemic in the future, the second risk being greater
than the first risk, and the third risk being greater than the
second risk; and ( c) displays the classification of the patient's
risk of being hypoglycemic on the display.
App. Br. 19 ( emphasis omitted).
In support Appellants argue:
More importantly, Kovatchev is silent as to determining
a total number of the N days during which the patient input at
least two blood samples to the handheld diabetes management
device; and/or in response to a determination that the total
number of the N days is greater than M: performing (a), (b),
and (c) of claim 1.
Second, this alternative testing frequency criteria is not
related to hypoglycemic risk classification.
5 We give the contested claim limitations the broadest reasonable
interpretation (BRI) consistent with the Specification. See In re Morris,
127 F.3d 1048, 1054 (Fed. Cir. 1997).
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Column 61, lines 39-40 of Kovatchev states that "a
superior Testing Frequency criteria may contribute more
significantly to the accuracy of Algorithm 1." Emphasis
added. Algorithm 1 of Kovatchev involves evaluation of
HbAlc - not hypoglycemic risk classification. See Kovatchev,
column 17, line 56.
App. Br. 22.
In the Final Action, we note the Examiner relies on a secondary
embodiment in Kovatchev ( algorithm 1) to support the "in response to"
contested claim language.
However, a secondary embodiment of Kovatchev discloses
these limitations inherently[ 6J. In the discussion concerning the
use of algorithm 1, Kovatchev discloses an alternative testing
frequency criterion, wherein the history of samples must
contain an average frequency of 1.8 readings per day for 35
days, out ofa total of60 days of readings (Col. 61, lines 35-52).
Final Act. 9.
6 "The inherent teaching of a prior art reference, a question of fact, arises
both in the context of anticipation and obviousness." In re Napier, 55 F.3d
610, 613 (Fed. Cir. 1995) (citation omitted) (affirmed 35 U.S.C. § 103
rejection based in part on inherent disclosure in one of the references). The
question of obviousness is "based on underlying factual determinations
including ... what [the] prior art teaches explicitly and inherently." In re
Zurko, 258 F.3d 1379, 1383 (Fed. Cir. 2001) (citations omitted) see also
PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186,
1195 (Fed. Cir. 2014) ("[t]he mere fact that a certain thing may result from a
given set of circumstances is not sufficient. If, however, the disclosure is
sufficient to show that the natural result flowing from the operation as
taught would result in the performance of the questioned function, it seems
to be well settled that the disclosure should be regarded as sufficient."
( citations omitted) ( emphasis added)).
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We emphasize that column 61, lines 35-52, reference algorithm 1 in
Kovatchev. See, e.g., "TABLE 17C Accuracy of Algorithm 1 in T2DM,;"
see also Kovatchev, col. 61, 11. 39--40 ("A superior Testing frequency
criterion may contribute more significantly to the accuracy of Algorithm
1.").
In response to Appellants' arguments in the Appeal Brief, the
Examiner further explains the basis for the rejection:
The primary citation of Kovatchev is directed to the
determination of hypoglycemic risk classification. The
secondary embodiment of Kovatchev is directed to the
evaluation of HbAlc, however this is a secondary embodiment
utilized in a 103 obviousness rejection. Evaluation of HbAlc is
directly related to a determination of a patient's risk of
hypoglycemia, as "HbA.sub. lc is the accepted 'gold standard'
for evaluation of glycemic control" (Kovatchev, Col. 19, lines
38-39) ....
Finally, Kovatchev also discloses a prerequisite
requirement that falls within the range required by the claims,
and is in reference to algorithm 2 for calculating a patient's risk
of hypoglycemia. Kovatchev at Col. 28, lines 41-48,
recommends that the "optimal SMBG data collection period
needed for estimation of the probability for future BSH or
BMH is 40 to 45 days. The optimal frequency of SMBG is 3 to
4 readings per day. Larger number of readings does not lead to
a substantial increase of the predictive power of Algorithm 2.
With less than 3 reading per day the predictive power declines."
The Office notes that this summary recommendation is with
respect to algorithm 2, that is, the algorithm disclosed in
Kovatchev that teaches the calculation and classification of the
patient's risk of developing hypoglycemia in the future.
Ans. 26, 27.
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Thus, we find the Examiner relies on algorithm 2 as a primary
embodiment in Kovatchev.
Turning to the dispositive portion of the evidence, Kovatchev
describes, in pertinent part: "This Example No. 1 consists of three
algorithms for simultaneous evaluation, from routine SMBG data, of the two
most important components of glycemic control in diabetes, HbA1c and risk
for hypoglycemia." Kovatchev, col. 17, 11. 46-50; see also, Kovatchev, col.
1 7, 11. 61---62 ("Algorithm 1 and 2 provide uninterrupted monitoring and
information about the overall glycemic control of an individual with Type 1
or Type 2 diabetes mellitus (TlDM, T2DM), covering both the high and the
low end of the BG scale.") ( emphases added.).
Based upon our review of the record, we find a preponderance of the
evidence supports a finding that the "in response to" contested limitation
recited in each of independent claims 1, 12, and 20, is not taught or
suggested by Kovatchev, because Kovatchev's algorithms 2 and 1 (relied on
by the Examiner as primary and secondary embodiments, respectively) do
not occur in response to each other, but instead are described as being used
concurrently for simultaneous evaluation. Kovatchev, col. 17, 11. 46-50.
See also, Kovatchev, col. 17, 11. 61---62 ("Algorithm 1 and 2 provide
uninterrupted monitoring and information about the overall glycemic control
of an individual with Type 1 or Type 2 diabetes mellitus (TlDM, T2DM),
covering both the high and the low end of the BG scale." (emphasis
added.)).
Because Kovatchev is silent regarding the contested chain of
causation ("in response to" -claims 1, 12, and 20), we find the Examiner's
proffered combination of Kovatchev' s embodiments ( algorithms 2 and 1) is
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unconvincing. We note the inventor's own path itself never leads to a
conclusion of obviousness - that is hindsight; what matters is the path that
the person of ordinary skill in the art would have followed, as evidenced by
the pertinent prior art. See 35 U.S.C. § 103 ("Patentability shall not be
negated by the manner in which the invention was made.").
Therefore, for essentially the same reasons argued by Appellants in
the Briefs, as further discussed above, we are constrained on this record to
reverse the Examiner's§ 103 rejection C of each independent claim 1, 12,
and 20 on appeal. Because we have reversed rejection C under § 103 for all
independent claims, for the same reasons, we reverse the Examiner's § 103
rejection C of all dependent claims on appeal.
Conclusions
The Examiner erred in rejecting claims 18 and 19 as being indefinite
under 35 U.S.C. § 112(b ).
The Examiner did not err in rejecting claims 1-20 under 35 U.S.C.
§ 101, as being directed to patent-ineligible subject matter.
The Examiner erred in rejecting claims 1-20 under 35 U.S.C. § 103,
as being obvious over Kovatchev.
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Application 14/039,762
DECISION
Because we have affirmed at least one ground of rejection with
respect to each claim on appeal, the Examiner's decision is affirmed. See
37 C.F.R. § 4I.50(a)(l).
We affirm the Examiner's decision rejecting claims 1-20.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). See
37 C.F.R. § 4I.50(f).
AFFIRMED
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