John Studdiford et al.

Patent Trials and Appeals Board

Mar 3, 2021

2020004498 (P.T.A.B. Mar. 3, 2021)

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.
15/350,506 11/14/2016 John P. Studdiford 117280-5001-US 1642
13356 7590 03/03/2021
Morgan, Lewis & Bockius LLP (CH)
1111 Pennsylvania Avenue, NW
Washington, DC 20004
EXAMINER
CORDAS, EMILY ANN
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
03/03/2021 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):
kcatalano@morganlewis.com
patents@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN P. STUDDIFORD and MAIREAD H. STUDDIFORD
____________

Appeal 2020-004498
Application 15/350,506
Technology Center 1600
____________

Before ERIC B. GRIMES, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to a method of detecting glucose in urine of a diabetic subject taking an
amount of a sodium glucose cotransporter 2 (SGLT2) inhibitor.1 Claims 1,
7–9, 11, 12, 14, 15, and 21–23 are on appeal as rejected under 35 U.S.C.
§ 103. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42.
Appellant identifies the Real Parties-in-Interest as the above-identified
named inventors. Appeal Br. 1.
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STATEMENT OF THE CASE
Independent claim 1 is representative and is reproduced below:
1. A method of detecting glucose in urine of a diabetic
subject taking an amount of a sodium glucose cotransporter 2
(SGLT2) inhibitor, the method comprising:
placing in a toilet bowl containing water a device that
comprises an absorbent substrate having one or more reagents in
an amount sufficient to react with glucose present in the toilet
bowl containing water and urine and produce a visually
detectable color change in a detection region of the device or a
visually detectable color change in the water of the toilet bowl;
collecting urine from the diabetic subject in the toilet
bowl;
waiting a predetermined period of time;
visually determining presence or absence of a color
change in the detection region of the device or a visually
detectable color change in the water of the toilet bowl to obtain
a test result,
recording the test result;
communicating the test result to a health care provider;
and
monitoring the effectiveness of the SGLT2 inhibitor based
on the test result,
wherein glucose is determined to be present in the urine
where the detection region changes color or the water of the toilet
bowl changes color, wherein the presence of glucose above a
threshold level indicates that the SGLT2 inhibitor is effective in
the diabetic subject,
wherein the device is paper, and wherein the device further
comprises a positive control region spatially separated from the
detection region and comprising glucose and one or more
reagents for detection of glucose.
Appeal Br. 17 (Claims Appendix).
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The Specification states that a variety of “[m]edications have been
developed to address various aspects of diabetes to lower blood glucose,”
but that “[a]ll of these medications, except for the SGLT2 inhibitors, reduce
blood glucose through mechanisms independent of the kidney, with the goal
of reducing blood glucose to target laboratory levels of HbA1c below 7%.”
Spec. ¶ 89. The Specification further states,
The effectiveness and safety of these medications has been well
proven, and although not all subjects reduce HbA1c to goal, they
generally eliminate glucose spillover from the kidney. As a
result there is typically little or no glucose in the urine for
subjects taking these classes of medications, except for the
SGLT2 inhibitors.
Id. The Specification states that “historically[,] glucose in the urine was seen
as a negative and proved a subject had uncontrolled diabetes,” but that “[w]ith
the use of SGLT2 inhibitors, the presence of glucose in the urine is both
necessary and positive because it proves the medication is working by
excreting unwanted sugar in the urine – resulting in lower blood glucose and
weight decrease in subjects taking these medications.” Id. ¶ 90.
The Specification states,
Due to the direct mechanism of action on the kidney and
corresponding glucose excretion in the urine, the ability to
monitor glucose excretion in the urine, as well as to easily show
health care providers and subjects that their prescribed SGLT2
inhibitor is working is both motivating and a positive
reinforcement tool to enhance adherence and compliance.
Id. ¶ 91. The Specification describes that a “threshold amount” of glucose to
be detected in urine by the invention is an amount above that exhibited “in
the urine of a normal subject (i.e., a subject that has not or is not taking a
SGLT2 inhibitor, or a normal subject without the disease or disorder such as
diabetes)” of, e.g., 5% to 500% or more. Id. ¶¶ 80, 93, 118, 120, 122, 123,
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125. The Specification also states that the invention is capable of detecting
urine-excreted glucose at concentrations from about 0.1 mg/dl to about 10
mg/dl or more. Id. ¶ 113. The Specification does not, however, identify any
specific amount or concentration of glucose in urine that, if detected,
indicates that an SGLT2 inhibitor is working effectively. See generally id.
The following rejection is appealed:
Claims 1, 7–9, 11, 12, 14, 15, and 21–23 stand rejected under
35 U.S.C. § 103 over Morgan,2 Tigges,3 Ismail,4 Poole,5 Noguchi,6 and
Nara.7 See Answer 4.
DISCUSSION
“[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).
Arguments made by Appellant in the Appeal Brief (no Reply Brief is in the
record) have been considered. See 37 C.F.R. § 41.37(c)(1)(iv) (2015); see
also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative)
(“Any bases for asserting error, whether factual or legal, that are not raised
in the principal brief are waived.”).

2 WO 2007/125272 A1 (published Nov. 8, 2007) (“Morgan”).
3 Dr. Michael Tigges, New Drugs Make Diabetics Pee out Excess Sugar
“DOT Physical & A1C,” Pulse, LinkedIn, https://www .linkedin.com/
pulse/new-drugs-make-diabetics-pee-out-excess-sugar-dot-physical-tigges,
Feb. 10, 2015. (“Tigges”).
4 US 5,116,729 (issued May 26, 1992) (“Ismail”).
5 Raewyn M. Poole & Rosselle T. Dungo, Ipragliflozin: First Global
Approval, 74 DRUGS 611–17 (2014) (“Poole”).
6 JP 8262010 A (published Oct. 11, 1996) (“Noguchi” – English translation).
7 US 2015/0152468 A1 (published June 4, 2015) (“Nara”).
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Regarding obviousness, “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). “[W]hen a patent claims a structure already known in the prior
art that is altered by the mere substitution of one element for another known
in the field, the combination must do more than yield a predictable result.”
Id. at 416 (citing U.S. v. Adams, 383 U.S. 39, 50–51 (1966)). “In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
What matters is the objective reach of the claim. If the claim extends to
what is obvious, it is invalid under § 103.” Id. at 419.
We review the Examiner’s determinations and Appellant’s arguments
in view of these standards of law.
As an initial note, Appellant argues the patentability of all claims as a
group. See generally Appeal Br. “Since the claims are not separately
argued, they all stand or fall together.” In re Kaslow, 707 F.2d 1366, 1376
(Fed. Cir. 1983). We address all claims together and all claims stand or fall
with independent claim 1.
The Examiner determines that the claims would have been obvious
over the combination of Morgan, Tigges, Ismail, Poole, Noguchi, and Nara.
Answer 4–19 (citing Morgan, 1:5–7, 2:5–8, 3, 5:14–19, 6:13–16, 8:1–9,
9:20–21, 10:6–12, 12:5–9, 14:20–24, 15:10–12, 16:8–10; Tigges, 2–3;
Ismail, 1:39–63, 2:24–28, 4:19–39; Poole, 611–13; Noguchi, Abstract, ¶¶ 1–
5; Nara, Abstract, ¶¶ 71–75, Table 1). The Examiner determines that the
skilled artisan would have been motivated to combine these references, as
they each are directed to treating, testing, or monitoring the health and
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treatment of diabetic patients and disclose complementary devices and
techniques for measuring glucose for this purpose, and the Examiner also
determines that the skilled artisan would have had a reasonable expectation
of success. Id. at 5–11, 17–19.
Appellant argues that Tigges’s disclosure that SGLT2 inhibiting drugs
lower diabetics’ blood glucose levels by removing glucose though the urine
and that patients taking these drugs will show high levels of glucose in their
urine does not teach testing for the presence of glucose in the urine. Appeal
Br. 12–13 (citing the Declaration of John Studdiford Under 37 C.F.R.
§ 1.132, dated Sept. 10, 2018, ¶¶ 8–9 (“Studdiford Declaration”). Appellant
argues that this disclosure by Tigges does not teach that high levels of urine
glucose are indicative of the effectiveness of such SGLT2 inhibitors. Id.
Appellant also argues that Ismail’s disclosure relating to frequently testing
and monitoring the effectiveness of diabetic patients’ treatments, e.g., insulin
injections, does not teach monitoring the effectiveness of an SGLT2
inhibitor in diabetic patients by monitoring urine glucose. Id. at 13–14.
Appellant argues that Poole only teaches that the administered dosage of the
SGLT2 inhibitor Ipragliflozin can be increased if it is determined to be
insufficient for efficacy, but does not teach a correlation between SGLT2
inhibitor efficacy and urine glucose. Id. at 14. Finally, Appellant argues
that Noguchi and Nara cannot remedy the deficiencies in the other prior art
references, that the Examiner used impermissible hindsight in determining
obviousness, that there would not have been motivation to combine the cited
prior art, and that detecting glucose in urine was traditionally considered
unreliable. Id. at 14–15 (citing the Studdiford Declaration ¶ 11).
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We find the Examiner has presented a prima facie case that the claims
would have been obvious and are not persuaded by Appellant’s arguments.
Morgan (e.g., at 3:6), Tigges (at 2), Ismail (e.g., at 1:39–55), and
Poole (e.g., at 611) each confirm that excess blood glucose is a universal
concern for diabetic patients. Tigges (at 3) and Poole (at 611, 613, and 615–
16) each teach that SGLT2 inhibitor drugs treat diabetes by allowing the
kidneys to filter and excrete glucose from the body, which is expelled in
urine. Poole teaches that the amount of excreted glucose is dose-dependent
on the SGLT2 inhibitor and that the dosage can be tailored for effectiveness.
Poole, 613 (“two studies in healthy volunteers, ipragliflozin (5–600 mg and
1–300 mg/day, respectively) demonstrated dose-dependent effects on
urinary glucose excretion,” “[m]aximum urinary glucose excretion (390
mmol/24 h) occurred at the 300 mg dose level,” and “dosage can be
increased . . . if the . . . dose has insufficient efficacy.”); see also id. at 615
(reporting observations in a phase III monotherapy trial and noting that all
doses of drug in patients resulted in “significant increases in urinary glucose
excretion compared with placebo, with a dose-effect observed after
adjustment for baseline values” with a maximum excretion level observed).
Ismail confirms that diabetic patients require frequent glucose testing,
e.g., every day or several times per day, to confirm their health and/or that
treatments are working. Ismail, 1:39–3:21 (discussing tests to detect glucose
in urine). Morgan teaches an effective, non-invasive way to test a diabetic
patient’s urine for glucose. See generally Morgan.
We agree with the Examiner that it would have been obvious to use
Morgan’s glucose indicator to confirm that Tigges’s or Poole’s SGLT2
inhibitors were effectively resulting in the diabetic patient excreting glucose
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in their urine, as intended. A simple, non-invasive test, such as Morgan’s,
would be advantageous because a diabetic patient may be required to
perform such a test daily or several times a day, as taught by Ismail.
We are not persuaded by Appellant’s argument regarding Tigges or
Poole. Tigges expressly teaches measuring glucose levels in a diabetic
patient’s urine, warning that, historically, glucose in urine would indicate
diabetes, but for diabetes patients taking SGLT2 inhibitors, glucose in urine
means the drugs are working. Tigges, 2–3. To recognize that a patient’s
urine has glucose, one would have to test the urine for glucose. Moreover,
Poole teaches that measuring glucose in urine is an indicator that an SGLT2
inhibitor is functioning effectively; where glucose is not observed in the
urine, Poole teaches that the dosage of the SGLT2 inhibitor can be
increased. Poole, 611–615. Poole teaches that urine glucose levels are
SGLT2-dose dependent. Id.
We are not persuaded by Appellant’s argument regarding Ismail.
Ismail may not be focused on testing urine glucose levels relating to
confirming SGLT2 effectiveness, but Ismail does teach or suggest that
diabetic patients require frequent testing to make sure their treatments are
effective. Ismail, 1:39–55. Moreover, Ismail does discuss measuring urine
glucose levels in diabetic patients using test strips. Id. at 1:64–3:4, 4:19–28.
Appellant’s other arguments, e.g., no motivation to combine,
Examiner’s alleged hindsight reasoning, unreliability of glucose tests, are
also not persuasive. The Examiner has identified sufficient reason to
combine the cited prior art and relies on only the disclosures of the prior art
in rejecting the claims. See Answer 4–19. Moreover, Ismail, Morgan, and
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Poole, as well as Tigges, each teach or suggest that one can reliably detect
levels of glucose in urine. See generally Ismail, Morgan, Poole, and Tigges.
For the reasons set forth above, we find that the Examiner presents a
prima facie case for obviousness and we are not persuaded by Appellant’s
arguments to the contrary. Therefore, we affirm the Examiner’s obviousness
rejection.
DECISION SUMMARY
In summary:
Claim(s)
Rejected 35 U.S.C. § References/Basis Affirmed Reversed
1, 7–9, 11,
12, 14, 15,
21–23
103
Morgan, Tigges,
Ismail, Poole,
Noguchi, Nara
1, 7–9, 11,
12, 14, 15,
21–23

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED