Julie Nicole. Hamblin et al.

Patent Trials and Appeals Board

Apr 3, 2020

15138277 - (D) (P.T.A.B. Apr. 3, 2020)

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.
15/138,277 04/26/2016 Julie Nicole HAMBLIN PB64335C3 US 9367
23347 7590 04/03/2020
GLAXOSMITHKLINE
Global Patents UP4110
1250 South Collegeville Road
Collegeville, PA 19426
EXAMINER
ANDERSON, REBECCA L
ART UNIT PAPER NUMBER
1626
NOTIFICATION DATE DELIVERY MODE
04/03/2020 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JULIE NICOLE HAMBLIN, PAUL SPENCER JONES,
SUZANNE ELAINE KEELING, JOELLE LE,
CHARLOTTE JANE MITCHELL, NIGEL JAMES PARR, and
ROBERT DAVID WILLACY
Appeal 2019-000417
Application 15/138,277
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
ELIZABETH A. LAVIER, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 16 and 17. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Glaxo Group
Limited d/b/a GlaxoSmithKline. Appeal Br. 4.
Appeal 2019-000417
Application 15/138,277
2
STATEMENT OF THE CASE
Claims 16 and 17 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 16 is representative of the claims on
appeal, and reads as follows:
16. A salt of N-[5-[4-(5-{[(2R,6S)-2,6-dimethyl-4-
morpholinyl]methyl}-1,3-oxazol-2-yl)-1 H-indazol-6-yl]-2-
(methyloxy)-3-pyridinyl] methanesulfonamide which is
selected from the group consisting of sodium, tosylate, maleate,
hemi pamoate, hemi naphthalenedisulfonate,
mesitylenesulfonate, hemi biphenyldisulfonate,
2-naphthalenesulfonate (napsylate), hemi cinnamate, hemi
sebacate, hemi pyromellitate and hemi benzenediacrylate.
Appeal Br. 13 (Claims Appendix).
REFERENCE(S)
The prior art relied upon by Examiner is:
Name Reference Date
Hamblin et al. (“Hamblin
’029”)
US 2010/0280029 A1 Nov. 4, 2020
Berge et al., Pharmaceutical salts, 66 J. Pharmaceutical Sciences 1–19
(1977) (“Berge”)
REJECTION(S)
Appellant requests review of the following rejections made by
Examiner:
I. Claims 16 and 17 under 35 U.S.C. § 103(a) as unpatentable
over Hamblin ’029 in view of Berge.
II. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over US 8,575,162 B2 in view of Berge.
III. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over US 8,609,657 B2 in view of Berge.
IV. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over US 8,735,390 B2 in view of Berge.
V. Claims 16 and 17 on the ground of nonstatutory obviousness
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type double patenting over US 9,102,668 B2 in view of Berge.
VI. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over US 9,326,987 B2 in view of Berge.
VII. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over US 9,353,098 B2 in view of Berge.
VIII. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over U.S. Patent Application No.
15/028,954 in view of Berge.
IX. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over U.S. Patent Application No.
15/433,010 in view of Berge.
X. Claims 16 and 17 on the ground of nonstatutory obviousness
type double patenting over US 2010/0280029 Al in view of
Berge.
OPINION
I. Obviousness over Hamblin ’029 in view of Berge
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that the claimed salt is obvious.
Findings of Fact (FF)
FF1 Hamblin ’029 teaches compounds of formula (I):

Formula (I), reproduced above, represents compounds that function as
inhibitors of kinase activity, in particular PI3-kinase activity.
Hamblin ’029 ¶¶ 28–30, 312.
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FF2 Hamblin ’029 teaches salts of formula (I), including sodium, malate,
p-aminobenzenesulfonate, p-toluenesulfonate (tosylate), and
napthalene-2-sulfonate. Hamblin ’029 ¶¶ 166–168, 248.
FF3 Hamblin ’029 teaches a product having the following structure:

The compound structure (Hamblin ’029 ¶ 520), reproduced above,
represents the chemical structure of the chemical formula N-[5-[4-(5-
{[(2R,6S)-2,6-Dimethyl-4-morpholinyl methyl}-1,3-oxazol-2-yl)-1H-
indazol-6-yl]-2-(methyloxy )-3-pyridinyl]methanesulfonamide.
Hamblin ’029 Example 1.
FF4 Berge teaches that “[s]alt formation is a means of altering the
physical, chemical, and biological characteristics of a drug without
modifying its chemical structure.” Berg 16; see also id. at 1 (“The
chemical, biological, physical, and economic characteristics of
medicinal agents can be manipulated and, hence, often optimized by
conversion to a salt form.”). “Theoretically, every compound that
exhibits acid or base characteristics can participate in salt formation.”
Id. at 2. “[D]ifferent salts of the same drug rarely differ
pharmacologically; the differences are usually based on the physical
properties.” Id. at 5 (quotation omitted).
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FF5 Berge teaches a list of FDA- approved commercially available salts
Berge 2 (table 1 (listing 53 salts)) as well as non-FDA approved
commercially available salts (id. at 3 (table 2)).
Principle of Law
“The 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).
Analysis
Examiner finds that Hamblin ’029 teaches the claimed composition
and suggests formulating the composition into salts, such as tosylate. Final
Act. 20; Ans. 5; FF1–FF3. Examiner relies on Berge for teaching that
compounds having an acid or base can be formulated into a salt. See Final
Act. 20–21; see also Ans. 5 (“combining a known drug with one of the
anions or cations disclosed in order to make a salt does not affect the basic
therapeutic properties of the drug”); see FF4–FF5. Examiner concludes that
it would have been obvious to a person of ordinary skill in the
art to prepare pharmaceutically acceptable salts as instantly
claimed to provide an improved formulation of the compounds
disclosed in US2010/0280029 as a person with ordinary skill
has good reason to pursue the known options within his or her
technical grasp.
Final Act. 21; Ans. 6.
Appellant contends that Examiner has not articulated a reason why the
claimed invention is obvious (Appeal Br. 7–10), and that the art is
unpredictable (Appeal Br. 9 (“it is clear [from Berge’s teaching] that such
salt selection is not at all certain”).
We are not persuaded by Appellant’s contention that Examiner has
not articulated a reason for making the combination. Here, Examiner
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identifies that Hamblin ’029 teaches the claimed compound and suggests
formulating the compound into a salt. Ans. 5; FF1–FF3. Examiner
recognizes that Hamblin ’029 does not teach all the claimed salt forms and,
therefore, relies on Berge for providing a list of FDA approved salts. Ans. 8.
Examiner reasons that “a person with ordinary skill has good reason to
pursue the known options within his or her technical grasp,” and Berge
presents a list of known salts that are reasonable options as a starting point
for making formulations. Ans. 6. The flexible analysis set out by the
Supreme Court in KSR recognizes the obviousness of pursuing known
options within the technical grasp of the skilled artisan, e.g., known
equivalents. See KSR, 550 U.S. at 421. Here, it is fair to say that
Hamblin ’029 suggests making salts while Berge provides a finite number of
identified salts that are routinely used in formulating drugs. FF2, FF4. We
agree with Examiner that it would be logical for one of ordinary skill in the
art of pharmaceutical formulations “to use Berge’s[2] list of FDA-approved
anions to produce a drug formulation. . . . This is true especially given the
fact that the genus of FDA-approved anions at the time was small, i.e.,
only 53.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1363 (2007).
We are also not persuaded by Appellant’s unpredictability argument.
Appeal Br. 9; Reply Br.3 2. Specifically, that the salt selection is not at all
certain. Appeal Br. 9. “[O]bviousness cannot be avoided simply by a
showing of some degree of unpredictability in the art so long as there was a

2 The Berge reference cited in Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1363 (2007) is the same document as relied on by Examiner in the present
appeal.
3 Appellant’s Reply brief is not paginated. Therefore, page numbers refer to
the document as if it were consecutively numbered beginning from the first
page.
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reasonable probability of success.” Pfizer, 480 F.3d at 1364. Berg teaches
that every compound that exhibits acid or base characteristics can participate
in salt formation. FF4. Berge teaches that “different salts of the same drug
rarely differ pharmacologically; the differences are usually based on the
physical properties.” FF4. Thus, Berge teaches that the production of salts is
reasonably expected to succeed while the function of the compound remains
the same. Berge does acknowledge that there may be no reliable way to
predict what physical, chemical, and thermodynamic properties the salt
would impart on the parent compound. Berge 2. The law, however, does not
equate unpredictability to patentability, and “expectation of success need
only be reasonable, not absolute.” Pfizer, 480 F.3d at 1364. (citing Merck &
Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed.Cir.1989); In re
O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)). Here, the combined
references provide a reasonable expectation of successfully forming a salt
from the parent compound that work for its intended purpose.
Conclusion
We conclude that the evidence cited by Examiner supports a prima
facie case of obviousness with respect to claim 16, and Appellant has not
provided sufficient rebuttal evidence that outweighs the evidence supporting
Examiner’s conclusion of obviousness. As Appellant does not argue the
claims separately, claim 17 falls with claim 16. 37 C.F.R. § 41.37 (c)(1)(iv).

II.–X. Nonstatutory obviousness-type double patenting in view of Berge
Appellant argues that the nonstatutory obviousness-type double
patenting rejections should be reversed. Appeal Br. 10–12. According to
Appellant, Berge “does not at all teach or suggest that the claimed invention
is obvious in combination with any reference.” Id. at 11–12.
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We are not persuaded by Appellant’s contention. Each of the claims
recited in the patents, patent applications, or patent publication relied on by
Examiner for the nonstatutory obviousness-type double patenting rejections
are directed to a compound having the same formula as the compound
recited in present claim 1. Because the same issue is dispositive for all of
these rejections, we will consider the rejections together. See Appeal Br. 11
(“argue[ing] all of these rejections in consolidation.”).
Claim 1 in US 8,575,162 B2 recites a salt of a compound having the
same formula set out in present claim 1. See e.g. US 8,575,162 B2 (claim 1);
see Final Act. 4–5. Berge teaches that different salts of the same parent
compound rarely have different functions. FF3. In other words, a salt form
would have been expected to have the pharmacological activity of the parent
compound. Berge teaches that depending on the salt the compound may
have different physical properties. Berge 2. Berge directs the skilled artisan
to a list of suitable salts. FF4. Examiner finds that Berge “teaches methods
of selecting and preparing salts . . . of drugs that would reasonably have been
expected to be applicable to the compounds of the ’162 patent. . . . A person
of ordinary skill in the art, upon reading the ’162 patent [claims], would also
have recognized the desirability of improved methods of formulating the
drug.” Final Act. 4–5. Examiner concludes that “[t]he claims would have
been obvious because a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads to the
anticipated success, it is likely the product is not of innovation but of
ordinary skill and common sense.” Id. at 5–6.
We agree with Examiner that based on the disclosure in the claims of
the US 8,575,162 B2 patent generically reciting salts, it would have been
obvious to try to formulate any of the salts disclosed in Berge to arrive at the
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presently claimed salts. “[E]xpectation of success need only be reasonable,
not absolute.” Pfizer, 480 F.3d at 1364. Here, the combination as presented
by Examiner does not require varying numerous parameters to arrive at a
salt, because in this case Berge’s list is not extensive. FF4. “[T]he mere
possibility that some salts may not form does not demand a conclusion that
those that do are necessarily non-obvious.” Pfizer, 480 F.3d at 1366.
We conclude, considering the totality of the cited evidence and
arguments, that the preponderance of the evidence supports Examiner’s
conclusion of that the claims in the US 8,575,162 B2 are not patentably
distinct in light of the teachings of Berge. Because Appellant does not argue
the nonstatutory obviousness-type double patenting rejections separately
(see Appeal Br. 11 (“argue[ing] all of these rejections in consolidation.”)),
we focused our discussion US 8,575,162 B2, and the other rejections fall for
the same reason. 37 C.F.R. § 41.37 (c)(1)(iv).
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
16, 17 103 Hamblin ’029, Berge 16, 17
16, 17 ODP
US 8,575,162 B2,
Berge
16, 17
16, 17 ODP
US 8,609,657 B2,
Berge
16, 17
16, 17 ODP
US 8,735,390 B2,
Berge
16, 17
16, 17 ODP
US 9,102,668 B2,
Berge
16, 17
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Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
16, 17 ODP
US 9,326,987 B2
Berge
16, 17
16, 17 ODP
US 9,353,098 B2,
Berge
16, 17
16, 17 ODP
U.S. Pat. App.No.
15/028,954, Berge
16, 17
16, 17 ODP
U.S. Pat. App.No.
15/433,010, Berge
16, 17
16, 17 ODP
US 2010/0280029 Al,
Berge
16, 17
Overall
Outcome
16, 17

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED