Ex Parte Leadbeater et al

Patent Trial and Appeal Board

Jun 12, 2017

13544082 (P.T.A.B. Jun. 12, 2017)

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.
13/544,082 07/09/2012 JOHN MICHAEL LEADBEATER Q126459 1150
23373 7590 06/14/2017
SUGHRUE MION, PLLC
2100 PENNSYLVANIA AVENUE, N.W.
SUITE 800
WASHINGTON, DC 20037
EXAMINER
DEES, NIKKI H
ART UNIT PAPER NUMBER
1791
NOTIFICATION DATE DELIVERY MODE
06/14/2017 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):
PPROCESSING@SUGHRUE.COM
sughrue@sughrue.com
USPTO@sughrue.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN MICHAEL LEADBEATER, VICTOR HEALD,
and NICHOLAS ALAN COOPER1
Appeal 2016-003057
Application 13/544,082
Technology Center 1700
Before PETER F. KRATZ, JEFFREY T. SMITH, and
JAMES C. HOUSEL, Administrative Patent Judges.
KRATZ, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the
Examiner’s Final Rejection of claims 1—5.2 We have jurisdiction pursuant to
35 U.S.C. §6.
1 The real parties of interest in this appeal is BAGGER-SORENSEN & CO.
A/S, assignee of record. App. Br. 2
2 In an appeal involving parent Application No. 10/520,786 (Appeal No.
2014-006572), a PTAB Decision affirming the Examiner’s rejection was
mailed on February 25, 2016.
Appeal 2016-003057
Application 13/544,082
Appellants’ claimed invention is directed to a compressed multi-layer,
medicated chewing gum tablet comprising at least two integral parts/layers
wherein one layer (first layer) includes compressed particulate gum base and
tablet base material and another layer (second layer) includes compressed
particulate tablet base material and a calcium (mineral) salt (Spec. 2,1. 15—
6,1. 24). Appellants disclose that the gum base may be any well-known gum
base and the tablet base material is preferably based on a sugar or polyol
(Spec. 3,1. 21—4,1. 6).
Claims 1 and 5 are illustrative and reproduced below:
1. A medicated chewing gum tablet comprising at
least two layers, a first layer comprising a compressed mixture
of particulated gum base material and separate particulated tablet
base material, and a second layer comprising a compressed
particulated tablet base material, wherein the second layer further
comprises an active ingredient being a mineral salt, wherein the
mineral is calcium.
5. A medicated chewing gum tablet comprising at
least two layers, a first layer comprising a compressed mixture
of particulated gum base material and separate particulated tablet
base material, and a second layer comprising a compressed
particulated tablet base material, wherein the second layer further
comprises an active ingredient being a calcium salt having
functional activity as bicarbonate.
The Examiner maintains the following grounds of rejection:
1. Claim 5 stands rejected under 35 U.S.C. § 112, second
paragraph as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
2. Claim 5 stands rejected under 35 U.S.C. § 112, first paragraph
as failing to comply with the written description requirement.
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3. Claims 1, 4, and 5 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Beringer (US 4,139,589; iss. Feb. 13, 1979) in view
of Della Posta (US 4,847,090; iss. Jul. 11, 1989).
4. Claims 1—5 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Beringer in view of Della Posta and Silva (US 4,867,989;
iss. Sep. 19, 1989).
5. Claims 1—5 stand provisionally rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 2, ^U10, 12-15, 17-19, 25-30, 32-37, 39-42, 44, 46-49, 51-53
and 55—72 of copending Application No. 10/520,786 in view of Silva.
We summarily affirm the uncontested provisional obviousness-type
double patenting rejection.
As for the contested rejections, we reverse the rejections under 35
U.S.C. § 112 substantially for reasons argued by Appellants and we affirm
the Examiner’s obviousness rejections for substantially the fact findings and
reasons advanced by the Examiner.
We offer the following for emphasis and completeness.
Rejection under 35 U.S.C. § 112, second paragraph
The Examiner maintains that claim 5 is indefinite because Appellants
have not clearly set forth what calcium salts would be included in the
medicated chewing gum of claim 5 by the proviso that the calcium salt be
such as to possess functional activity as a bicarbonate (Ans. 5; Final Act. 4).
Appellants contend that the claim language concerning the calcium
salt is clear and would encompass mineral salts comprising calcium
carbonate/bicarbonate because an ordinarily skilled artisan “would
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Application 13/544,082
understand that bicarbonate functionality arises from the addition of a
mineral carbonate/bicarbonate in water” (App. Br. 23).
The Examiner contends that while it may be well-known that an
ordinarily skilled artisan would recognize that it is a mineral
carbonate/bicarbonate salt which when ingested forms the functional
ingredient bicarbonate, the Specification and claims, as originally filed, do
not indicate that a calcium salt having such functionality was contemplated
(Ans. 25).
However, the Examiner fails to explain why one of ordinary skill in
the art would not have been reasonably apprised of the scope of claim 5
based on the Examiner’s assertions as to a lack of descriptive support.
Consequently, we concur with Appellants’ argument in that the
Examiner has not discharged the burden to establish that claim 5 runs afoul
of the definiteness requirements of the second paragraph of 35 U.S.C.
§112.
Hence, we reverse the Examiner’s rejection of claim 5 under the
second paragraph of 35 U.S.C. § 112.
Rejection under 35 U.S.C. § 112, first paragraph
The Examiner maintains that “[t]he specification and claims as
originally filed provide no support for a calcium salt having functional
activity as bicarbonate” (Ans. 2; Final Act. 3).
In this regard, Appellants’ Specification discloses that bicarbonate, a
mineral, or a mineral salt, among other listed potential ingredients, may be
employed as an active ingredient of the chewing gum tablet (Spec. 5,11. 20—
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31). Furthermore, Appellants’ Specification discloses that calcium may be
employed as a mineral (Spec. 6,11. 20—23).
In addition, original claim 5 of the present Application (Application
No. 13/544082 filed 07/09/2012) describes “an active ingredient being a
calcium salt having functional activity as bicarbonate” (claim 5).
In light of the above, we concur with Appellants that the Examiner
has not established that claim 5 lacks written descriptive support in the
present Application, as filed.
It follows that we reverse the Examiner’s rejection of claim 5 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.
Obviousness Rejections
Concerning the rejections under 35 U.S.C. § 103(a) and after review
of the opposing positions articulated by Appellants in the Briefs and the
Examiner in the Final Office Action and in the Answer taking into account
the evidence of obviousness adduced by the Examiner in light of the
countervailing Declaration evidence proffered by Appellants, we determine
that Appellants’ arguments and evidence are insufficient to outweigh the
evidence of obviousness marshalled by the Examiner. Thus, Appellants
have not identified reversible error in the Examiner’s obviousness rejections.
In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
Accordingly, we affirm the stated obviousness rejections for
substantially the fact findings and the reasons set forth by the Examiner in
the Final Office Action and in the Examiner’s Answer. We offer the
following for emphasis only.
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Application 13/544,082
Appellants argue the rejected claims together as a group for both
obviousness rejections.3 Accordingly, we select claim 1 as the
representative claim on which we focus in deciding this appeal as to both
obviousness grounds of rejection.
As more fully set forth in the Examiner’s Answer and in the Final
Action, the Examiner has determined that Beringer teaches or suggests, inter
alia, a compressed, multi-layered chewing gum tablet including layered
granulated tablet mass and granulated gum mass wherein the multi-layer
tablet can be manufactured using gum base-containing granulate according
to the Figure 10 embodiment, which may include a middle layer containing
chewing gum base granules and outer tablet layers comprising a sweetener
and wherein active ingredients may be incorporated in the tablet mass or
chewing gum mass (Final Act. 5, 8; Ans. 3—4, 6—7; Beringer, abstract; col. 1,
11. 7-45; col. 2,11. 3-30, col. 3,11. 40-44, col. 6,1. 30-col. 7,1. 26; col. 7,1.
46—col. 9,1. 26; Examples 1—12; Figs. 1, 4, 10).
Given the Figure 10 tablet manufacturing embodiment and the
disclosures of Beringer concerning the plastic mass (gum base —containing
composition) which can include sugar (tablet mass), the Examiner has
determined, in essence, that Beringer teaches or suggests forming a tablet
stmcture that corresponds to Appellants’ tablet structure having at least two
3 In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[W]e hold that the
Board reasonably interpreted Rule 41.37 to require more substantive
arguments in an appeal brief than a mere recitation of the claim elements and
a naked assertion that the corresponding elements were not found in the
prior art.”). Here, Appellants’ representations as to what claims 2 (2nd
obviousness rejection only), 4, and 5 further recite are unavailing as separate
arguments for separately considering the patentability of the above-
identified and affected claims (App. Br. 21).
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compressed layers with at least one layer comprising compressed gum base
containing chewing gum (gum base) granules and granulated tablet mass as
required by representative claim 1 but for teaching that one layer includes
calcium salt in addition to compressed particulate tablet base material (Final
Act. 5—6, 8, 15; Ans. 3—4, 6—7, 13—14; Beringer, Fig. 10; Examples 2—5, 6—
11).
The Examiner relies on Della Posta for suggesting medicated chewing
gum including at least two layers wherein a layer of the gum product, such
as a layer including tablet base material (sugar, sorbitol), may include a
mineral salt comprising calcium carbonate as the medication/active
ingredient and wherein the layers may have different textures (Final Act. 6,
9; Ans. 5, 7; Della Posta, Abstract, col. 3,1. 64—col. 4,1. 6, col. 6,1. 29- col.
7,1. 54, col. 8,11. 18—34, claims 14, 15).
Based on the combined teachings of Beringer and Della Posta
(Rejection 3) and Beringer, Della Posta, and Silva (Rejection 4), the
Examiner determines that it would have been obvious to an ordinary skilled
artisan to employ a mineral salt, such as calcium carbonate, as the active
ingredient in a granulated tablet mass containing gum layer of Beringer’s
multi-layer chewing gum to obtain the expected predictable benefits of such
a known medicinal/nutrient additive (Final Act. 5—11; Ans. 5—10; Della
Posta, col. 3,1. 60-col. 4,1. 6).
In light of the above and for reasons more fully set forth by the
Examiner in the Answer and in the Final Rejection, the principal argument
raised by Appellants, that is, that Beringer does not teach or suggest but
rather teaches away from a multi-layer chewing gum tablet having a layer
comprising a compressed mixture of gum base material (gum) and a tablet
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base material (sugar) (layer 2, Figure 10; Examples 2—5, 7—12) and a layer
comprising a compressed particulate tablet base material (Figure 10, layer 1
or layer 3), wherein any of the layers, such as layer 1 or layer 3, can further
include an active ingredient (col. 1,11. 10—37), which meets the requirements
of the tablet of representative claim 1 but for the calcium mineral salt, as the
active ingredient, lacks persuasive merit (App. Br. 2—19; Reply Br. 4—8;
Declarations 1 and 2 of Dr. Jesper Neergaard). Nor have Appellants’
unsubstantiated contentions exposed harmful error in the Examiners’
additional determination that the combined teachings of Beringer and Della
Posta (Rejection 3) and/or Beringer, Della Posta, and Silva (Rejection 4)
would have suggested the use of calcium carbonate as an active ingredient
for use in the chewing gum tablet of Beringer.
In particular and concerning the Examiner’s application of a tablet
made in accordance with Beringer’s Figure 10 embodiment as a tablet that
includes at least two layers, much of Appellants’ argument and Declaration
evidence centers on Appellants’ position that the Examiner misinterprets
Beringer as to the chewing gum formulation that the Examiner has
determined one of ordinary skill in the art would have been led to employ in
forming a multi-layer chewing gum tablet in accordance with the Figure 10
embodiment; such as, a chewing gum formula as is exemplified in certain
examples of Beringer, which include at least some amount of tablet base
material (sugar) together with the gum base content for the chewing gum
tablet layer 2 of Figure 10 (App. Br. 12—19; Reply Br. 4—8).
In the Declaration executed on April 29, 2011 (Deck I), Dr. Neergaard
opines that the granule plastic mass of Examples 6 through 12 of Beringer
are suitable for a single layer multi-zone tablet of Beringer and would yield
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non-sticky granules, Examples 1 through 5 of Beringer address a pre-formed
disc embodiment of Beringer, and none of the compositions of Examples 1—
12 of Beringer would be suitable for the Figure 10 multi-layer tablet forming
embodiment of Beringer (Deck I 6—11). Dr. Neergaard further opines
that chewing gum tablets require new chewing gum formulations and that
traditional chewing gum compositions are not generally applicable for use in
manufacturing chewing gum tablets (Decl. I 12—15).
In the Declaration executed on June 19, 2012 (Decl. II), Dr.
Neergaard reports that attempts at manufacturing three-layered tablets via
the Figure 10 technique of Beringer while using a plastic mass granulate
composition in accordance with Example 6 of Beringer did not successfully
yield useful three-layer chewing gum tablets because of poor mechanical
properties and that similar failures would be expected for the granulate
plastic mass compositions of Examples 7—11 of Beringer (Decl. II 4, 5,
Exhibit A).
Appellants contend that the submitted Declaration evidence
substantiate or buttress their argument that Beringer would not have led one
of ordinary skill in the art to a multi-layer product gum tablet formed by
employing granulates in making gum base-containing layer(s) by employing
a gum base composition as required by representative claim 1 when using
the Figure 10 embodiment taught by Beringer for making the multiple layer
tablet and using a gum composition in accordance with the Examples of
Beringer, as modified by Della Posta or Della Posta and Silva, for the gum
base-containing plastic layer and the second layer containing a calcium
mineral salt active ingredient in accordance with the additional teachings of
Della Posta and/or Della Post and Silva. In this regard and as contended to
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be consistent with the Declaration evidence, Appellants argue that Examples
6 through 12 of Beringer, as well, as Example 1, are directed to other
embodiments of Beringer, not the Figure 10 embodiment, and an ordinarily
skilled artisan would not have modified the Figure 10 embodiment to
employ compositions as set forth in the Examples of Beringer for a middle
plastic granular layer as they would have been unsuitable for forming a gum
tablet via the Figure 10 embodiment as substantiated by the Declarations of
Dr. Neergaard.
Contrary to the argument and evidence furnished by Appellants,
however, we concur with the Examiner’s obviousness conclusion because
the applied prior art taken as a whole outweighs the evidence furnished by
Appellants for the reasons substantially as articulated by the Examiner in the
Answer and as discussed above (see generally Ans.). In particular, we
concur with the Examiner that Beringer teaches using a granulated plastic
mass in the Figure 10 embodiment and would have reasonably suggested to
one of ordinary skill in the art to use a plastic mass for granulation like the
plastic masses described in the examples, such as Example 6—12 (Ans. 13—
24 ; see Final Act. 15). In this regard, we further observe that Dr.
Neergaard’s attempt at manufacturing tablets by duplicating the Figure 10
method of Beringer fall short by cooling the plastic mass to -75°C for the
grinding/granulation given that Beringer, in describing the Figure 10
embodiment for making a multi-layer tablet using granules for the layers,
teaches that granulation of the chewing gum mass should be conducted at a
temperature between —20 to + 10°C (Decl. II, Exhibit A; Beringer, col. 6,11.
56—59; Example 6). The Declaration evidence and the argument presented
in the Appeal Brief fail to articulate how the use of a significantly lower
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granulation cooling temperature of -75°C that is significantly outside the
disclosed range of temperatures taught by Beringer as being appropriate for
cooling during granulation is consistent with the disclosure of Beringer.
Moreover, the ingredients employed in Example 6 of Beringer were not
duplicated, as noted in the plastic mass preparation description provided in
the Declaration, and merely stating that the relatively small amounts of the
ingredients used by Beringer that were omitted from the duplication effort
for lack of availability were unimportant fails to adequately address the
effect of this formulation duplication deviation (Deck II, Exhibit A). Nor
have Appellants established that one of ordinary skill in the art would not
have been able, through routine experimentation, to perform adjustments to
the gum composition (such as by adding additional known tablet binders,
etc.) and adjust relevant process conditions so as to yield tablets having
acceptable physical characteristics using the Figure 10 embodiment of
Beringer. Consequently, Appellants have not carried the burden of
production in presenting evidence sufficient to establish Beringer as being
unworkable for the Figure 10 embodiment.
In this regard, Beringer expressly teaches that “[t]he various layers of
tablet mass and various elements or layers of plastic mass of one and the
same tablet may have different substances mixed in with them and/or be
differently coloured” (Beringer, col. 4,11. 8—12). Moreover, Beringer
expresses a recommendation for proceeding with using granulate for the
plastic mass just as with the tablet mass (Beringer, col. 2,11. 5—19). Beringer
describes the Figure 10 embodiment as being suitable for making a multi­
layer tablet in accordance with Figure 1 and Beringer describes
compositions in Examples 1 through 11 for the three-layer tablet according
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to Figure 1 (col. 6,11. 30-35; col. 7,1. 48 — col. 9,1. 17). In addition,
Beringer describes placing the granulate made in Example 6 from plastic
mass in a mold not in a mixer as occurs in Example 12 and the Figure 11
single layer tablet embodiment. Thus, we disagree with Appellants’
contention that Beringer would have discouraged one of ordinary skill in the
art from employing compositions, such as identified and disclosed in
Examples 1 through 11 of Beringer as a plastic mass composition for use in
the Figure 10 embodiment of Beringer.
In addition, Appellants argue that the representative claim 1 gum is
characterized by the unexpected property of being crunchy before being
chewy (App. Br. 19). This argument lacks persuasive merit for reasons
expressed by the Examiner (Ans. 23). The Declarations of Dr. Neergaard do
not address the Experimental Report Annex HE 4 (Evidence Appendix, Item
3) and Appellants do not articulate how the Examples tested in the
Experimental Report have a nexus and/or are commensurate in scope with
representative claim 1. Consequently, we attach no credible weight to the
Report Annex HE 4.
For reasons set forth above and for reasons articulated by the
Examiner, the cited Declarations by Dr. Jesper Neergaard fail to shift the
weight of the evidence in Appellants’ favor upon reconsideration anew in
light of all of the relevant evidence.
Consequently, Appellants have not identified reversible error in the
Examiner’s stated obviousness rejections and the preponderance of the
evidence supports the Examiner’s fact findings and reasoning in maintaining
the rejection.
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For the reasons set forth above and as stated by the Examiner in the
Answer, it follows that we shall sustain the Examiner’s obviousness
Rejections 3 and 4.
CONCLUSION/ORDER
The Examiner’s decision to reject the appealed claims is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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