Ex Parte Breton et al

Patent Trials and Appeals Board

Jun 24, 2019

13634040 - (D) (P.T.A.B. Jun. 24, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/634,040 11/21/2012
158251 7590 06/26/2019
University of Virginia (DexCom)
c/o Buchanan Ingersoll & Rooney PC
Post Office Box 1404
Alexandria, VA 22314
FIRST NAMED INVENTOR
Marc D. Breton
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.
0087407-000057 6455
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
06/26/2019 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):
ADIPDOCl@bipc.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARC D. BRETON, STEPHEN D. PATEK,
BORIS P. KOVATCHEV, and COLLEENS. HUGHES 1
Appeal2017-008254
Application 13/634,040
Technology Center 1600
Before CHRISTOPHER G. PAULRAJ, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims to a method for delivering insulin which have been
1 Appellants identify the Real Parties in Interest as the National Institutes of
Health, United States Department of Health and Human Services, and the
University of Virginia Patent Foundation. Appeal Br. 2.
2 We have considered and herein refer to the Specification of Sept. 11, 2012
("Spec."); Final Office Action of Apr. 4, 2016 ("Final Act."); Appeal Brief
of Oct. 4, 2016 ("Appeal Br."); Examiner's Answer of Mar. 13, 2017
("Ans."); and Reply Brief May 15, 2017 ("Reply Br.").
Appeal2017-008254
Application 13/634,040
rejected directed to non-statutory subject matter. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM, but designate our affirmance a new ground of rejection.
STATEMENT OF THE CASE
"Hypoglycemia is common in type 1 diabetes (TlDM) and becomes
more prevalent in type 2 diabetes (T2DM) with treatment intensification."
Spec. 1. "[Severe hypoglycemia] may cause cognitive dysfunction, coma, or
sudden death. Consequently, hypoglycemia has been identified as the
primary barrier to diabetes management." Id.
"Insulin Pump and Pen therapy is becoming increasingly prevalent in
TlDM and is recommended as means for improvement of glycemic control
in T2DM as well." Delivery of insulin by an insulin pump or pen is
determined primarily through glucose monitoring. Id. The Specification
describes a system that uses requests for insulin as the primary signal for
hypoglycemia monitoring. Id.
Claims 1-7 and 24--37 are on are on appeal. Claim 1 representative of
the rejected claims and reads as follows:
1. A processor-implemented method for delivering
insulin to a diabetic patient, the method comprising:
detecting, by a processor, a signal requesting delivery to
said patient of an amount of insulin from an insulin delivery
device, prior to said signal being sent to said insulin delivery
device;
in response to detection of an insulin delivery request
signal, determining, by a processor, whether delivery of said
amount of insulin will result in hypoglycemia in said patient,
based on an assessment of blood glucose level of said patient;
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Application 13/634,040
in response to a determination that delivery of said
amount of insulin will result in hypoglycemia, outputting, by a
processor, a signal requesting further action by said patient;
in response to a signal indicating further action by said
patient, sending to said insulin delivery device said signal
requesting delivery of an amount of insulin to said patient,
whereby said amount of insulin is delivered to said patient; and
in the absence of a signal indicating further action by said
patient, preventing said signal requesting delivery of an amount
of insulin to said patient from being sent to said insulin delivery
device, whereby said amount of insulin is not delivered to said
patient.
The claims have been rejected under 35 U.S.C. § 101 are directed to
patent-ineligible subject matter.
DISCUSSION
Issue
The issue with respect to this rejection is whether the Examiner
properly determined that the claims are directed to patent-ineligible subject
matter.
The Examiner finds that while the claims are directed to a process or
system, the claims are directed to determining the glucose level of a patient
and then determining the amount of insulin to be administered. Final Act.
4--5. The Examiner finds that determining blood glucose level and the
amount of insulin are mathematical relationships and determination of that
relationship is nothing more than an abstract idea. Id. at 5. The Examiner
goes on to find that the additional limitations relating to the delivery of
insulin are well known and do not amount to anything significantly more
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that the abstract idea. Id. The Examiner concludes that the claims are
directed to patent-ineligible subject matter.
Appellants have not argued the claims separately. We, therefore,
choose claim 1 as representative for our analysis.
Analysis
Claim Construction
Before we tum our analysis under section 101, we construe the claims
to aid our determination of whether the claims are directed to patent-
ineligible subject matter. See Bancorp Services, L.L. C. v. Sun Like Assur.
Co. of Canada (U.S.), 687 F.3d 1266, 1273-74 (Fed. Cir. 2012) (court
construed claim terms to aid in analysis under 35 U.S.C. § 101).
During examination, claims are given their broadest reasonable
interpretation consistent with the specification. See In re Am. Acad. of Sci.
Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). "Construing claims
broadly during prosecution is not unfair to the applicant . . . because the
applicant has the opportunity to amend the claims to obtain more precise
claim coverage." Id.
Here claim 1 is directed to a method for delivering insulin where the
delivery of insulin is performed only if a certain condition is met. Claim 1
reads in part:
in response to a determination that delivery of said
amount of insulin will result in hypoglycemia, outputting, by a
processor, a signal requesting further action by said patient;
in response to a signal indicating further action by said
patient, sending to said insulin delivery device said signal
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requesting delivery of an amount of insulin to said patient,
whereby said amount of insulin is delivered to said patient; and
in the absence of a signal indicating further action by said
patient, preventing said signal requesting delivery of an amount
of insulin to said patient from being sent to said insulin delivery
device, whereby said amount of insulin is not delivered to said
patient.
Appeal Br. Claims App 'x. Claim 1 makes it clear that insulin is not
administered unless a signal indicating further action by the patient is
received. In the absence of the signal, no insulin is administered. In
other words, the administration of insulin is conditioned on the receipt
of the signal.
The claims in the present case are similar to those in Ex parte
Schulhauser, Appeal No. 2013-007847 (PTAB Apr. 28, 2016)
(precedential). In Schulhauser, the claims at issue were directed to a
method for monitoring cardiac conditions using an implantable
medical device. Id. at 2. The claimed method included three steps
that were only performed if a certain conditions were met. Id. at 2-3.
The claims were rejected under 35 U.S.C. § 103(a) over a
combination of references that the Examiner asserted taught the
recited method. Id. at 4.
On appeal to the Board, the appellant in Schulhauser contended
that the combined teachings of the references did not disclose "the
particular order and conditions imposed on the various comparing,
determining and triggering steps by the limitations of independent
claim 1." Id. at 5. The Board found this is argument unpersuasive.
Id.
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In Schulhauser, the Board found that several steps of the
claimed process only needed to be performed if certain conditions
precedent were met. Id. at 6. If the conditions were not met, the
additional steps were not performed. Id. Applying the broadest
reasonable interpretation standard, the Board interpreted the claim as
covering two different methods, one where the additional steps are
performed and another where they are not performed. Id. at 8. The
Board concluded that the broadest reasonable interpretation covered
the method where the additional steps need not be performed. Id.
Like the claim at issue in Schulhauser, claim 1 on appeal covers
two methods with different outcomes, one where insulin is delivered
to a patient and one where insulin is not delivered. Thus, under the
guidance set forth in Schulhauser, we determine under the broadest
reasonable interpretation of the claims that the claim method does not
require administering insulin.
Patent-Eligible Subject Matter
An invention is patent eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101. Here,
there is no dispute that representative claiml falls within the statutory
category of a "process." However, the Supreme Court has long interpreted
35 U.S.C. § 101 to include implicit exceptions to those statutory categories:
i.e., "[l]aws of nature, natural phenomena, and abstract ideas" are not
patentable. E.g., Alice Corp. v. CLS Bank Int'!, 573 U.S. 208,216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
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and Alice. Alice, 573 U.S. at 217-18 ( citing Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with
that framework, we first determine what concept the claim is "directed to."
See Alice, 573 U.S. at 219 ("On their face, the claims before us are drawn to
the concept of intermediated settlement, i.e., the use of a third party to
mitigate settlement risk."); see also Bilski v. Kappas, 561 U.S. 593, 611
(2010) ("Claims 1 and 4 in petitioners' application explain the basic concept
of hedging, or protecting against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and
mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 191
(1981) ); "tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores" (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267---68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that "[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula." Diehr, 450 U.S. at 176; see also id. at 191 ("We
view respondents' claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula."). Having
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said that, the Supreme Court also indicated that a claim "seeking patent
protection for that formula in the abstract ... is not accorded the protection
of our patent laws, ... and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment." Id. (citing Benson and Flook); see, e.g., id. at 187 ("It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.").
If the claim is "directed to" an abstract idea, we tum to the second
step of the Alice and Mayo framework, where "we must examine the
elements of the claim to determine whether it contains an 'inventive
concept' sufficient to 'transform' the claimed abstract idea into a patent-
eligible application." Alice, 573 U.S. at 221 ( quotations marks omitted). "A
claim that recites an abstract idea must include 'additional features' to
ensure 'that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea]."' Id. ( quoting Mayo, 566 U.S. at 77).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
The PTO recently published revised guidance on the application of
§ 101. USPTO's January 7, 2019 Memorandum, 2019 Revised Patent
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Subject Matter Eligibility Guidance ("Memorandum"). 3 Under that
guidance, we first look to whether the claim recites:
( 1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing human
activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.0S(a}-(c), (e}-(h)).
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim:
(3) adds specific limitations beyond the judicial exception that are not
"well-understood, routine, conventional" in the field (see MPEP
§ 2106.0S(d)); or
( 4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception.
See Memorandum.
We begin our analysis by asking whether the claimed method is
directed to one or more of the judicial exceptions. The guidance identifies
three judicially-excepted groupings: (1) mathematical concepts, (2) certain
methods of organizing human behavior such as fundamental economic
practices, and (3) mental processes. Ex parte Smith, Appeal No. 2018-
3 While the rejection was issued before the Memorandum was released, the
methodology set forth in the Memorandum applies to this Appeal.
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000064 (PTAB Feb. 1, 2019) (informative). Claims directed to natural
phenomena are also ineligible for patent protection. Flook, 437 U.S. at 593.
Under Step 2A, Prong 1 of the Memorandum, we must first determine
whether the claim "recites" a judicial exception. Here, we find that the
claims recite several functions that can be performed by a human either
mentally or using pen and paper. In particular, claim 1 recites: (1)
"detecting ... a signal requesting delivery to said patient of an amount of
insulin from an insulin delivery device," (2) "determining ... whether
delivery of said amount of insulin will result in hypoglycemia in said patient,
based on an assessment of blood glucose level of said patient," (3)
"outputting . .. a signal requesting further action by said patient," and (4)
"in the absence of a signal indicating further action by said patient,
preventing said signal requesting delivery of an amount of insulin to said
patient from being sent to said insulin delivery device, whereby said amount
of insulin is not delivered to said patient."
Although claim 1 recites that "a processor" performs the foregoing
italicized functions, we find that the same functions can be otherwise
performed either in the human mind or using pen and paper, and, therefore,
are considered mental processes. See CyberSource Corp. v. Retail
Decisions, Inc., 654 F.3d 1366, 1372-73 (Fed. Cir. 2011) ("All of claim 3's
method steps can be performed in the human mind, or by a human using a
pen and paper .... Such a method that can be performed by human thought
alone is merely an abstract idea and is not patent-eligible under§ 101.");
Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir.
2016) ("[W]e continue to 'treat[] analyzing information by steps people go
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through in their minds, or by mathematical algorithms, without more, as
essentially mental processes within the abstract-idea category.'") ( citation
omitted).
For example, leaving aside the processor limitations, the claimed
method can be performed by a medical professional such as a nurse, who
receives a request from a patient to administer insulin. The nurse then
determines if the requested amount of insulin might result in hypoglycemia
based on an assessment of the patient's blood glucose levels. If the nurse
determines there is a risk of hypoglycemia, the nurse then asks the patient
for confirmation of the request. If no confirmation is received, the nurse
takes no further action, thereby preventing the administration of insulin.
Only if confirmation is received, does the nurse administer insulin to the
patient. But as discussed above, under the broadest reasonable interpretation
of claim 1, the administration step is not required by the claim, and thus not
considered in our analysis. Each of the remaining steps can be performed
mentally or with a pen and paper. The steps fall within the mental process
category of abstract ideas.
Additionally, we find that the claim's recitation of "determining ...
whether delivery of said amount of insulin will result in hypoglycemia in
said patient, based on an assessment of blood glucose level of said patient"
can also be categorized as a law of nature, another judicial exception. In
Mayo, the Supreme Court held that a claim reciting the step of "determining
the level of 6-thioguanine in said subject having said immune-mediated
gastrointestinal disorder" was patent-ineligible, noting that "the
'determining' step tells the doctor to determine the level of the relevant
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metabolites in the blood, through whatever process the doctor or the
laboratory wishes to use." 566 U.S. at 79. As with the "determining" step in
that case, the "determining" step in claim 1 allows for an assessment of the
levels of blood glucose, another metabolite within the body, using any
method known in the art. See Spec. 1 :23-25 (noting that "blood glucose
readings ... are traditionally obtained by self-monitoring (SMBG) or, more
recently, by continuous glucose monitoring (CGM)"); id. at 3:10-12 (stating
that the "Insulin Delivery Supervisor (IDS)" described as aspect of the
invention "can be implemented in any system based on insulin pump or pen
and will work with either SMBG or CGM modes of blood glucose
monitoring"). As such, we find that this step merely assesses the natural
correlation of blood glucose levels to a patient's risk of hypoglycemia.
Appellants contend that the present claims are directed to improved
insulin delivery technology which helps prevent hypoglycemia. Appeal Br.
6. Appellants contend that, like the claims in McRO, 4 the present claims
require that certain steps be performed in a specific order. Id. at 6-7.
Appellants contend that the claimed method when viewed as a whole, is not
directed to mathematical relationships. Id. at 7.
We have considered Appellants' arguments and are not persuaded.
As discussed above, other than the conditional step of administering insulin,
and the recitation of a generic processor, the recited steps can be performed
in the mind of a human or by pen and paper. Furthermore, the claimed
determining step requires an assessment of the naturally occurring
4 McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed.
Cir. 2016).
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correlation of blood glucose levels to hypoglycemia in the patient. As such,
we determine under Step 2A, Prong 1 of the Memorandum that claim 1
recites an abstract idea (mental process) and a law of nature.
Following the Office's guidelines, we next determine under Step 2A,
Prong 2 of the Memorandum if the claim integrates the judicial exception
into a practical application. As part of this analysis, and most relevant to the
issue presented here, we take into consideration whether the claim recites
"an additional element that applies or uses a judicial exception to effect a
particular treatment or prophylaxis for a disease or medical condition."
Memorandum, 55. To this point, Appellants contend that the claimed
method is an improved method for administering insulin. Appeal Br. 6. We
would agree with Appellants if the claims required a step of administering
insulin, since such a method would similar to the claims at issue in Vanda
Pharms. Inc. v. West-Ward Pharms. Int'! Ltd., 887 F.3d 1117 (Fed. Cir.
2018). In Vanda, the claimed method included alternative limitations calling
for administration of specific doses of a drug, with the dose depending on
the patient's genotype. Id. at 1134. Our reviewing court found that the
limitations requiring the administration of the drug distinguished that
claimed method from the method at issue in Mayo, and therefore found the
claims to be patent eligible. Id. at 1135-36.
Unlike the claims in Vanda, however, claim 1 at issue here does not
require the administration of insulin under the broadest reasonable
interpretation. As discussed above, the method may conclude without
administration of the drug to the patient in the absence of a signal indicating
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further action by said patient. Thus, we determine that the claim does not
require the treatment of any disorder.
In accordance with the Office's guidelines, other exemplary
considerations that may be indicative that an additional element ( or
combination of elements) may have integrated the exception into a practical
application include whether: "[a]n additional element reflects an
improvement in the functioning of a computer, or an improvement to other
technology or technical field," "an additional element implements a judicial
exception with, or uses a judicial exception in conjunction with, a particular
machine or manufacture that is integral to the claim an additional element
effects a transformation or reduction of a particular article to a different state
or thing," or "an additional element applies or uses the judicial exception in
some other meaningful way beyond generally linking the use of the judicial
exception to a particular technological environment, such that the claim as a
whole is more than a drafting effort designed to monopolize the exception."
Memorandum, 55. To the extent applicable, we do not find that any of these
additional considerations indicate that claim 1 integrates the judicial
exception into a practical application. For instance, the claim does not
reflect any improvement to the functioning of a computer such as in McRO,
in which the claimed invention focused on a specific improvement to
computer animation. 837 F.3d at 1314. Nor does claim 1 involve any
particular machine or thing, or the transformation of a particular article into
a different state or thing.
In accordance with the second part of the Alice/Mayo test, we consider
whether the claim contains an "inventive concept" sufficient to "transform
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the nature of the claim into a patent-eligible application." Alice, 134 S.Ct. at
2355 (quotation omitted). As part of this inquiry under Step 2B of the
Memorandum, we determine whether the claim recites limitations beyond
the judicial exception that are not well-understood, routine, and conventional
in the field. Memorandum, 56. As to this question, the Examiner finds that
the delivery of insulin to a subject is well-known, routine and conventional
in the field of diabetes management. Final Act. 5. Specifically, the
Examiner finds that the recited devices in the claim, such as processors,
input devices, connection devices and insulin delivery devices are well-
known and conventional. Ans. 7. The Examiner concludes that these
additional devices do not confer patentability on the claimed method.
Appellants contend that the recited method employs unconventional
steps to a particularly useful application of a principle, the unconventional
steps render the method patentable. Appeal Br. 7. In support of this
contention, Appellants point to the limitation calling for the transmission of
signal requesting further action and the requirement that a response be
received before insulin is administered. Id. at 8-10. Appellants also point to
the fact that the Examiner has not raised any rejection based on novelty or
obviousness, suggesting that the claimed method is not well-known, routine
or conventional. Id. at 8.
Appellants' arguments do not persuade us that the Examiner's
conclusion that the claims are directed to ineligible subject matter is in error.
Under the broadest reasonable interpretation, the claimed involve steps that
can be performed mentally. Even if these steps were novel and unobvious,
they would not render the method patentable, because the allegedly novel
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and unobvious aspects of the claim are nonetheless directed to an abstract
idea and law of nature. See Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d
1369, 1376 (Fed. Cir. 2016) ("[U]nder the Mayo/Alice framework, a claim
directed to a newly discovered law of nature ( or natural phenomenon or
abstract idea) cannot rely on the novelty of that discovery for the inventive
concept necessary for patent eligibility; instead, the application must provide
something inventive, beyond mere 'well-understood, routine, conventional
activity.'"). Appellants do not dispute the Examiner's finding that the
additional tangible elements recited in the claim, such as a processor and
insulin delivery device, are all well-known, routine, and conventional. Ans.
10.
Based on the foregoing analysis, we conclude that the claims are
directed to a judicial exception without significantly more, and therefore not
eligible for patent protection.
NEW GROUNDS OF REJECTION
As discussed above, in addition to affirming the Examiner's
determination that the claims are directed to an abstract idea, we also
determine that the claims are directed to a law of nature. As our reasoning
differs from the Examiner's analysis, we designate our affirmance as a new
ground of rejection to preserve Appellants' procedural safeguards. 37
C.F.R. § 4I.50(b).
Rule 37 C.F.R. § 4I.50(b) states that "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
Further, §4I.50(b) also provides that Appellants, WITHIN TWO MONTHS
FROM THE DATE OF THE DECISION, must exercise on of the following
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options with respect to the new grounds 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 [e]vidence relating to the
claims so rejected or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner ....
(2)Request rehearing. Request that the proceeding be reheard
under § 51.52 by the Board upon the same record ....
No time period for taking any subsequent action in connection with this
appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 101, and designate our
affirmance a new ground of rejection.
AFFIRMED
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