Fredrik Hodin et al.

Patent Trials and Appeals Board

Sep 20, 2019

12808315 - (D) (P.T.A.B. Sep. 20, 2019)

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.
12/808,315 06/15/2010 Fredrik Hodin SWEDM.003APC 2365
20995 7590 09/20/2019
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
FELTON, MICHAEL J
ART UNIT PAPER NUMBER
1747
NOTIFICATION DATE DELIVERY MODE
09/20/2019 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):
efiling@knobbe.com
jayna.cartee@knobbe.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte FREDRIK HODIN
and JORGEN LUNDIN
____________

Appeal 2018-004998
Application 12/808,315
Technology Center 1700
____________
Before KAREN M. HASTINGS, MICHAEL P. COLAIANNI, and
GEORGE C. BEST, Administrative Patent Judges.
BEST, Administrative Patent Judge.
DECISION ON APPEAL
The Examiner finally rejected claims 13–17, 19, 22, 27–32, 34, 36–
50, 52, and 53 of Application 12/808,315 under 35 U.S.C. § 103(a) as
obvious. Final Act. (July 12, 2017). Appellant1 seeks reversal of these
rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction under
35 U.S.C. § 6.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Swedish
Match North Europe AB. Appeal Br. 3.
Appeal 2018-004998
Application 12/808,315
2
An oral hearing in this appeal was held on September 12, 2019. A
transcript of that hearing will be placed into the ’315 Application’s
prosecution history when it becomes available.
For the reasons set forth below, we reverse.
BACKGROUND
The ’315 Application describes snuff or snus comprising tobacco or
non-tobacco material and magnesium carbonate. Spec. 1. According to the
Specification, both tobacco and non-tobacco snuff or snus products need to
be stored under conditions that maintain “a sufficiently high and fairly
constant pH during the entire storage period.” Id. The pH must be
maintained at a fairly high level “to increase the amount of unprotonized
nicotine which is absorbable by the mucous membrane. At increased pH[,]
bacterial growth is also prevented.” Id. Sodium carbonate is the most
common pH regulating material used in the formulation of moist snuff
products. Id. Although sodium carbonate is cheap and easy to handle, it does
not convey upon the moist tobacco products a sufficiently long shelf life. Id.
The ’315 Application’s Specification describes the use of magnesium
carbonate as a pH maintenance agent. Id. at 2. According to the
Specification, magnesium carbonate—which is less soluble in water than
sodium carbonate—service as a carbonate depot, slowly releasing carbonate
ions to maintain a stable pH. Id.
Claims 13 and 28 are representative of the ’315 Application’s claims
and are reproduced below from the Claims Appendix of the Appeal Brief.
13. A moist oral tobacco snuff or snus product, comprising:
a pouch containing loose tobacco;
water;
Appeal 2018-004998
Application 12/808,315
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admixed magnesium carbonate; and
a pH-regulator selected from the group consisting of
sodium carbonate, sodium bicarbonate, sodium hydroxide,
potassium carbonate, potassium bicarbonate, potassium
hydroxide, and phosphates, or any combination thereof,
wherein the water is present in an amount of from about 30 to
60% by weight of the oral tobacco snuff or snus product; and
wherein the admixed magnesium carbonate and the pH
regulator are present in an amount sufficient to maintain the pH
of the moist oral tobacco snuff or snus product between a pH of
8 to 9 after storage at room temperature for at least 90 days.
Appeal Br. 22.
28. An oral non-tobacco snuff or snus product, comprising:
a pouch containing loose non-tobacco bulk plant fiber
material;
a pH-regulator selected from the group consisting of
sodium carbonate, sodium bicarbonate, sodium hydroxide,
potassium carbonate, potassium bicarbonate, potassium
hydroxide, and phosphates, or any combination thereof; and
admixed magnesium carbonate, wherein the oral non-
tobacco snuff or snus product does not contain any tobacco, and
where the admixed magnesium carbonate and the pH regulator
are provided in an amount sufficient to maintain the pH of the
oral non-tobacco snuff or snus product between a pH of 8 to
and 9 after storage at room temperature for at least 90 days.
Appeal Br. 23.
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Application 12/808,315
4
REJECTIONS
On appeal, the Examiner maintains the following rejections:
1. Claims 13–17, 19, 22, 27–32, 34–36, 52, and 53 are rejected under
35 U.S.C. § 103(a) as unpatentable over the combination of
Hansson,2 Adusumilli,3 Ciolino,4 and NDSN.5 Answer 3.
2. Claims 41–44 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Hansson, Adusumilli, and
Holton.6 Answer 7.
3. Claims 13, 15–17, 22, and 38–40 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Holton and
Adusumilli. Answer 8.
DISCUSSION
Rejection 1. The Examiner rejected claims 13–17, 19, 22, 27–32, 34–
36, 52, and 53 as unpatentable over the combination of Hansson,
Adusumilli, Ciolino, and NDSN. Answer 3.
Appellant presents four arguments for reversal of this rejection:
(1) and Adusumilli is non-analogous art, Appeal Br. 19, (2) at this merely
does not teach or suggest “admixed magnesium carbonate” in combination

2 US 2005/0061339 A1, published March 24, 2005.
3 US 2004/0037879 A1, published February 26, 2004.
4 Laura A. Ciolino et al., The Relative Buffering Capacities of Saliva and
Moist Snuff: Implications for Nicotine Absorption, 25 J. Anal. Toxicol. 15
(2001).
5 National Drug Strategy Network, New Questions About Snuff Tobacco
Industry (1994).
6 US 2007/0186941 A1, published August 16, 2007.
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Application 12/808,315
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with other elements of the pending claims, id. at 9–12, (3) the cited
references do not teach or reasonably suggest adding the admixed
magnesium carbonate and pH regulator in an amount sufficient to maintain
the pH of the snuff or snus product between 8 and 9 after storage room
temperature 90 days, id. at 12–14, and (4) the claimed invention achieves
unexpected results sufficient to overcome the prima facie case of
obviousness set forth in the Final Action and Answer, id. at 15–18. We
address each of these arguments below.
First, we take up Appellant’s argument that Adusumilli is non-
analogous art. A reference is available for use in a § 103(a) rejection only if
it is analogous art. In re Kahn, 441 F.3d 977, 986–87 (Fed. Cir. 2006); In re
Oetiker, 977 F.3d 1443, 1447 (Fed. Cir. 1992). A reference is analogous art
only if it either (1) is in the field of the inventor’s endeavor or (2) is
reasonably pertinent to the particular problem with which the inventor was
concerned. Oetiker, 977 F.3d at 1447.
In this case, we only consider the first prong of the test. Appellant
argues that the inventors’ field of endeavor is defined by the following
statement in the Specification: “The current invention pertains to a tobacco
product or a non-tobacco snuff product comprising a magnesium carbonate.”
Appeal Br. 19 (quoting Spec. 1).
The Examiner does not provide a substantive response to this
argument. See Answer 8–10.
Notwithstanding the Examiner’s failure to respond to Appellant’s
argument, we are not persuaded that the Examiner reversibly erred by
finding that Adusumilli is analogous art.
“The Supreme Court’s decision in KSR International Co. v. Teleflex,
Inc., . . . directs us to construe the scope of analogous art broadly.” Wyers v.
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Application 12/808,315
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Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010). The test for
determining an applicant’s field of endeavor “requires the PTO to determine
the appropriate field of endeavor by reference to explanations of the
invention’s subject matter in the patent application, including the
embodiments, function, and structure of the claimed invention.” In re Bigio,
381 F.3d 1320, 1325 (Fed. Cir. 2004).
The Specification’s describes the dual purpose for maintaining a
fairly-high, constant pH during storage: increasing the amount of nicotine
which is readily observable by the mucous membrane and preventing
bacterial growth. Spec. 1. The Specification further states:
At a basic pH, nicotine of a tobacco product is more readily
absorbed by the mucous membrane. . . . Stability of the pH in
the basic region is directly correlated to and a prerequisite for
storage ability. Below 7, and insubstantial amount of nicotine is
released from the tobacco-containing product, whereas a too
basic pH may cause damage to the mucous membrane.
Id. at 4.
Based upon the Specification’s emphasis on the availability of
nicotine for absorption, we find that the inventors’ field of endeavor is oral
nicotine delivery devices.
Adusumilli, which describes an oral dosage formulation comprising
nicotine for use as a nicotine replacement therapy, falls within this field of
endeavor. Adusumilli’s describes an oral dosage formulation that releases
nicotine in the oral and/or buccal cavity. Adusumilli ¶ 7.
We, therefore, are not persuaded to reverse the rejection based upon
Appellant’s non-analogous art argument.
Second, Appellant argues that the rejection should be reversed
because “Adusumilli does not teach or reasonably suggest ‘admixed
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Application 12/808,315
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magnesium carbonate’ in combination with the other elements of the
pending claims.” Appeal Br. 9–12 (bolding omitted).
This argument is not persuasive of the existence of reversible error.
As the Examiner found, Hansson describes mixing the tobacco mass with a
suitable buffer “such as e.g.[,] carbonate.” Hansson ¶ 23. We discern no
reversible error in the Examiner’s finding, Answer 3–4, that Adusumilli
describes magnesium carbonate as a useful buffer in an oral nicotine
delivery product.
Third, Appellant argues that the rejection should be reversed because
the cited references do not describe or suggest using magnesium carbonate at
a pH regulator in an amount sufficient to maintain the pH of the product
between a pH of 8–9 after room temperature stored for at least 90 days.
Appeal Br. 12–15. The Examiner relied upon test data reported in Ciolino
and NDSN as the basis for this finding. The Examiner, however,
acknowledged that neither of these references report the length of storage
before the pH of the products were determined. Answer 5. The Examiner,
however, argues that “it would have been obvious that the pH of at least
some of the products exceeded a pH of 8 after significant storage and
distribution time.” Id.
Because neither Ciolino nor NDSN expressly describe the claim
limitation, the Examiner is relying upon the principal of inherency as the
basis for the finding that the prior art describes or suggests the 90 day pH
maintenance limitation. However, “[i]nherency . . . may not be established
by probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.” Hansgirg v. Kemmer,
102 F.2d 212, 214 (CCPA 1939).
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Application 12/808,315
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Thus, the Examiner erred by finding that the prior art describes or
suggests the 90 day pH maintenance limitation. This is reversible error.
Fourth, Appellant argues that the claimed combination achieves
unexpected results. Appeal Br. 15–18. The Examiner determined that
Appellant’s evidence of unexpected results need not be considered because
Appellant relies upon data that is not commensurate in scope with the claims
“because the claims are directed to products stored at room temperature for
90 days while the declaration only provides data for products stored 28
days.” Answer 10.
The Examiner’s failure to consider the data in the Inventors’ May 2,
2016 Declaration is reversible error. The Declaration specifically states that
the products were stored for periods of up to 28 days at elevated
temperatures before the pH was measured and that storage at these elevated
temperatures was equivalent to storage for a longer time periods at room
temperature. Declaration ¶¶ 8–10, Table 3, Table 4. The Examiner neither
addresses these contentions nor presents evidence that the statements in the
Declaration are incorrect. Thus, the Examiner should have considered
whether or not the data presented by the Declaration is sufficient to
overcome any prima facie case of obviousness that might have existed.
For the reasons set forth above, we determine that the Examiner
reversibly erred in rejecting claims 13–17, 19, 22, 27–32, 34–36, 52, and 53
as obvious over the combination of Hansson, Adusumilli, Ciolino, and
NDSN.
Rejection 2. The Examiner rejected claims 41–44 as unpatentable
over the accommodation of Hansson, Adusumilli, and Holton. Answer 7. In
doing so, the Examiner relies upon Hansson and Adusumilli as describing or
suggesting each limitation in independent claims 13 and 28. Id. Claims 41–
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Application 12/808,315
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44 depend, directly or indirectly, from either claim 13 or claim 28. Appeal
Br. 25. As discussed above, we have determined that the Examiner
reversibly erred in rejecting claims 13 or 28. We, therefore, also reverse the
rejection of claims 41–44.
Rejection 3. The Examiner rejected claims 13, 15–17, 22, and 38–40
as unpatentable over the combination of Holton and Adusumilli. Answer 8.
As discussed above, we have determined that the Examiner reversibly erred
by failing to consider Appellant’s evidence of unexpected results. We,
therefore, reverse this rejection.
CONCLUSION
In summary:
Claims
Rejected Basis Affirmed Reversed
13–17, 19, 22, 27–
32, 34–36, 52, and
53
§ 103(a)
Hansson,
Adusumilli, Ciolino,
and National Drug
Strategy Network

13–17, 19, 22,
27–32, 34–36,
52, and 53
41–44
§ 103(a)
Hansson,
Adusumilli, and
Holton
41–44
13, 15–17, 22, and
38–40
§ 103(a)
Holton and
Adusumilli
13, 15–17, 22, and 38–40
Overall Outcome
13–17, 19, 22,
27–32, 34,
36–50, 52, and
53
REVERSED