Knoze Jr. Corporation

Patent Trials and Appeals Board

Nov 24, 2021

2021000887 (P.T.A.B. Nov. 24, 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.
15/706,177 09/15/2017 Shunsheng Han 1093-004DIV1 2013
145340 7590 11/24/2021
Caldwell Intellectual Property Law
200 Clarendon Street
59th Floor
Boston, MA 02116
EXAMINER
GITOMER, RALPH J
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
11/24/2021 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):
alexander@caldwellip.com
eofficeaction@appcoll.com
rachel@caldwellip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SHUNSHENG HAN

Appeal 2021-000887
Application 15/706,177
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected claims 1, 3–5, and 7–22 under 35 U.S.C. § 103
as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject the claims. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE and set forth new grounds of rejection pursuant to 37
C.F.R. § 41.50(b).

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 Knoze Jr.
Corporation. Appeal Br. 3.
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STATEMENT OF THE CASE
Claims 1, 3–5, and 7–22 are rejected by the Examiner as follows:
Claims 1, 3, 4, 7–18, and 20–22 under 35 U.S.C. § 103 as obvious in
view of Sarama et al. (US 2003/0113361 Al, published June 19, 2003)
(“Sarama”). Non-Final Act. 2.
Claim 5 under 35 U.S.C. § 103 as obvious in view of Sarama and
Greenberg (US 2014/0030241 Al, published Jan. 30, 2014). Non-Final Act.
3.
Claim 19 under 35 U.S.C. § 103 as obvious in view of Sarama and
Bauer et al. (US 2010/0055082 Al, published Mar. 4, 2010) (“Bauer”). Non-
Final Act. 5.
Independent claim 1 is reproduced below (with indentations added to
clarify the different components in the claim):
1. A formulated oral prebiotic edible composition useful for
promoting a desired oral microbiota to treat an allergy related
respiratory condition in a subject in need of such treatment
comprising:
a free amino acid containing ingredient comprising L-
arginine, the L-arginine comprised of free individual molecules
of L-arginine, the free individual molecules of L-arginine
present at a concentration of greater than about 0.1 wt%;
a carrier, and
a sugar comprising least one of a monosaccharide and
disaccharide;
the composition in a configuration suitable to be
maintained including being substantially dissolved within the
oral cavity to provide the free individual molecules of L-
arginine over a period of at least about 1 minute to about an
hour in an effective amount to thereby selectively promote an
increased concentration of selected oral microbiota to thereby
treat the allergy related respiratory condition, the selected oral
microbiota comprising Veillonella and Streptococcus.

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OBVIOUSNESS REJECTIONS BASED ON SARAMA
The Examiner found that Sarama describes a composition comprising
“L-arginine comprised of free individual molecules of L-arginine,” a carrier,
and a “a sugar comprising at least one of a monosaccharide and
disaccharide” as required by claim 1. Non-Final Act. 2–3. The Examiner
found that claims differ from Sarama in that Sarama does not specify the
weight percent of arginine as 0.1 wt. %. Id. at 3. However, the Examiner
found the recited weight percent to be obvious because “the amounts of the
components described in Sarama are total amounts and not taught as wt%
which could readily be varied to provide the desired total amounts.” Id. The
Examiner also states that no “criticality is seen in any of the claims wt%
which are broadly claimed, such as greater than about 0.1 wt%.” Id.
Appellant argues that Sarama “does not disclose, teach, or suggest ‘a
free amino acid ingredient comprising L-arginine,’ as disclosed in claim 1 of
the present applicant, but rather discloses a form of esterified L-arginine that
is hydrolyzed in vivo to produce free L-arginine.” Appeal Br. 13.
The Examiner responded to this argument by citing paragraph 44 of
Sarama which discloses that “[t]he L-arginine utilized herein may be used in
its free form or may be utilized as a polypeptide, a salt, and/or a pro-form.”
Ans. 6 (citing Sarama ¶ 44).
We review appealed rejections for reversible error based upon the
issues identified by Appellant and in light of Appellant’s arguments and
evidence. 37 C.F.R. § 41.37(c)(1)(iv); Ex parte Frye, 94 USPQ2d 1072,
1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had
failed to make a prima facie case, “it has long been the Board’s practice to
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require an applicant to identify the alleged error in the examiner’s
rejections”)). As explained in more detail, we find that the Examiner erred in
determining that the claims are obvious in view of Sarama.
As indicated by the Examiner, and not challenged by Appellant,
Sarama discloses that “L-arginine is a natural amino acid which has been
identified to provide certain general health benefits including, for example,
cardiovascular benefits, such as lowering cholesterol in the consumer, and
treating, preventing, and/or inhibiting heart disease and poor circulation.”
Sarama ¶ 4. However, Sarama further discloses
Unfortunately, L-arginine and its close derivatives (including
salts, polypeptides, and pro-forms) have a strong, bitter, and
fishy flavor, making L-arginine generally unacceptable for use.
This results in decreased compliance of a regimen involving L-
arginine, and the requisite cardiovascular benefits are therefore
not realized. Accordingly, to enhance compliance, it would be
desirable to provide L-arginine in a form which diminishes
and/or removes the unacceptable flavor associated with L-
arginine.
Sarama ¶ 5.
Sarama further discloses that it “becomes increasingly more difficult
to mask the strong, bitter, and fishy flavor” of arginine when large amounts
of arginine, “about 3 grams to about 10 grams of L-arginine per dose,” are
delivered. Sarama ¶ 6. Sarama discloses that these “difficulties manifest
themselves in the marketplace, where it is understood that current products
containing L-arginine are not acceptable to the consumer due to
unacceptable flavor.” Id. To address this problem, Sarama discloses that
“inventors have surprisingly discovered that the unacceptable flavor of L-
arginine is significantly improved through esterification of the L-arginine.”
Id. ¶ 7.
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The thrust of Sarama, therefore, is on administering an L-arginine
ester, which as Appellant argues, is not “free individual molecules of L-
arginine” as required by the claim. The disclosure in paragraph 44 of Sarama
about using L-arginine in its free form is not a disclosure of using free form
arginine in the compositions described by Sarama because, in the same
paragraph, Sarama discloses “[b]ecause the L-arginine herein is esterified at
the carboxylic acid site, the L-arginine salts herein will be anionic salts.” Id.
In other words, the “free form” can be used in Sarama to make the esterified
arginine ester; it is not administered in the free form because of the problems
described by Sarama in paragraphs 5–7.
The disclosure discussed above in paragraphs 5–7 of Sarama suggests
that there are compositions in the prior art comprising free individual
molecules of arginine, but this is not the rejection before us.
Because we find Sarama deficient in describing free individual
molecules of L-arginine, we reverse the obviousness rejection of claim 1,
and dependent claims 3, 4, 7–18, and 20–22.
We also reverse the obviousness rejections of dependent claims 5 and
19 because these rejections are based on the improper application of Sarama
as discussed above.
With respect to claim 19 which is directed to the composition of claim
1 and further comprising live bacteria, the Examiner cited Bauer. Bauer
describes extracts from Lactobacillus bacteria. Bauer ¶ 1. The Examiner did
not explain how the disclosure of a bacteria extract suggests the live bacteria
in claim 19.

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OBVIOUSNESS BASED ON MELLO
Pursuant to 37 C.F.R. § 41.50(b), we set forth a new ground of
rejection. The new ground of rejection is as follows:
Claims 1 and 22 are rejected under 35 U.S.C. § 103 as obvious in
view of Mello et al. (WO 2011/162756 Al, published Dec. 29, 2011)
(“Mello”).
The following findings of fact (“FF’) are pertinent to the rejection:
FF1.
The oral care composition of the preferred embodiments includes
arginine in free or salt form, a mucoadhesive polymer, optionally
at least one antibacterial agent, and at least one component
selected from the group consisting of pyrophosphate compounds,
zinc salts, potassium salts, strontium salts, and mixtures thereof.
The composition preferably is in the form of a mouthwash or
mouthrinse.
Mello ¶ 22.

FF2. “The compositions described herein contain arginine in free or
salt form.” Mello ¶ 24.
FF3.
The arginine in free or salt form may be present in the
compositions described herein in an amount of 0.1 wt.% to 20
wt.% of the total composition weight, preferably from 0.25 wt.%
to 5 wt.% of the total composition weight, for example from
0.4% to 2.5%, or from 0.5% to 2%, or from 0.6% to 1 %, or from
0.75% to 0.9% by weight, based on the total weight of the
composition.
Mello ¶ 28.
FF4. “The compositions of the present invention also contain a
mucoadhesive polymer.” Mello ¶ 29. “Preferred mucoadhesive polymers are
those that enhance the delivery and retention of the agents to, and retention
thereof on oral surfaces.” Id. ¶ 30.
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FF5.
Preferred oral care compositions include those selected from
dentifrices, oral rinses, oral strips, lozenges, beads, liposomes,
micelles, reverse micelles, micro- or nanoencapsulated
containers, enzymes, proteins, gels, sol-gels, hydrogels, silicas,
organic zeolites, inorganic silicas such as those present in
dentifrice, paint-ons, oral patches, polymers, sprays, smoke
inhalatation devices, foams, chewing gums, from the back or
through a toothbrush head, oils or other products used for oral
hygiene or benefit.
Mello ¶ 44.
FF6.
In other embodiments, the oral compositions comprise an edible
oral strip comprising one or more polymeric film forming agents
and an effective amount of the combination of extracts discussed
above.
Mello ¶ 66.

FF7.
Among useful carriers for optional inclusion in a composition of
the invention are diluents, abrasives, bicarbonate salts, pH
modifying agents, surfactants, foam modulators, thickening
agents, viscosity modifiers, humectants, sweeteners, flavorants
and colorants. One carrier material, or more than one carrier
material of the same or different classes, can optionally be
present. Carriers should be selected for compatibility with each
other and with other ingredients of the composition.
Mello ¶ 53.

FF8.
In a still further embodiment the composition may include at
least one sweetener, useful for example to enhance taste of the
composition. Any orally acceptable natural or artificial
sweetener can be used, including without limitation dextrose,
sucrose, maltose, dextrin, dried invert sugar, mannose, xylose,
ribose, fructose, levulose, galactose, corn syrup (including high
fructose corn syrup and corn syrup solids), partially hydrolyzed
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starch, hydrogenated starch hydrolysate, sorbitol, mannitol,
xylitol, maltitol, isomalt, aspartame, neotame, saccharin and salts
thereof, dipeptide-based intense sweeteners, cyclamates and the
like. One or more sweeteners are optionally present in a total
amount depending strongly on the particular sweetener(s)
selected, but typically 0.005% to 5% by weight of the
composition.
Mello ¶ 61.
Rejection
Claim 1 requires an “edible” composition comprising 1) “a free amino
acid containing ingredient comprising L-arginine, the L-arginine comprised
of free individual molecules of L-arginine”; 2) “the free individual
molecules of L-arginine present at a concentration of greater than about
0.1 w%”; 3) “a carrier”; and 4) “a sugar comprising at least one of a
monosaccharide and disaccharide.”
Mello discloses that its composition can be a lozenge, chewing gum,
or an edible oral strip, meeting the “edible” limitation recited in the
preamble of claim 1. FF5, FF6.
Mello describes an oral composition comprising free L-arginine in an
amount of 0.1 wt.% to 20 wt.% of the total composition weight. FF1–FF3.
The amounts of arginine in Mello overlap with the claimed amount of
“greater than about 0.1 w%” (numbered above as 2). It is well established
that, when there is a range disclosed in the prior art, and the claimed
invention overlaps or falls within that range, as occurs here, there is a
presumption of obviousness. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.
Cir. 2004).
Mello also discloses that the composition can comprise a carrier as
recited in claim 1 (numbered above as 3). FF7.
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Mello further discloses that its composition can comprise sweeteners,
including dextrose (a monosaccharide), fructose (a monosaccharide), and
sucrose (a disaccharide), which are required by claim 1 (numbered above as
4). FF8.
It would have been obvious to one of ordinary skill in the art before
the effective filing date of the application to provide an edible oral
composition with the free arginine in an amount of at least 0.1 wt%, a
carrier, and at least one of a monosaccharide and disaccharide because each
of these components are described as useful by Mello.
Claim 1 further requires:
the composition in a configuration suitable to be
maintained including being substantially dissolved within the
oral cavity to provide the free individual molecules of L-arginine
over a period of at least about 1 minute to about an hour in an
effective amount to thereby selectively promote an increased
concentration of selected oral microbiota to thereby treat the
allergy related respiratory condition, the selected oral microbiota
comprising Veillonella and Streptococcus.
Mello’s composition can be formulated as lozenge, chewing gum, or
edible oral strip (FF5, FF6), each of which would be expected to be resident
in the mouth for more than a minute, releasing the L-arginine into the oral
cavity. Mello also discloses the addition of mucoadhesive polymers that
“enhance the delivery and retention of the agents to, and retention thereof on
oral surfaces” (FF4), providing further reason to believe that introducing the
oral composition of Mello to the mouth would lead to its retention for more
than a minute to release the L-arginine.
Mello does not describe that its formula “selectively promote[s] an
increased concentration of selected oral microbiota to thereby treat the
allergy related respiratory condition, the selected oral microbiota comprising
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Veillonella and Streptococcus.” But because Mello has the same ingredients
in the same amounts as required by claim 1, the composition made obvious
by Mello would reasonably be expected to possess the same activity as the
claimed composition. As held in In re Best, 562 F.2d 1252 (CCPA 1977):
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
Whether the rejection is based on “inherency” under 35 U.S.C. §
102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly
or alternatively, the burden of proof is the same, and its fairness
is evidenced by the PTO’s inability to manufacture products or
to obtain and compare prior art products.
Id. at 1255 (footnote omitted) (citation omitted).
Independent claim 22 is similar to claim 1, but the free individual
molecules of L-arginine are present at a concentration of greater than about
2.4 wt%. Mello describes free arginine in amounts of 0.1 wt.% to 20 wt.%,
encompassing the claimed amount. Because the claimed amount falls with
the range disclosed by Mello, it is presumed to be obvious. Peterson, 315
F.3d at 1329; Iron Grip Barbell, 392 F.3d at 1322.
For the foregoing reasons, a new ground of rejection of claims 1 and
22 as obvious in view of Mello is made pursuant to 37 C.F.R.
§ 41.50(b). We have not reviewed the remaining claims to determine
whether these claims are obvious based on Mello, Sarama, Greenberg,2
Bauer, or other prior art. We leave it to the Examiner to determine the
appropriateness of any further rejections based on these or other references.

2 Greenberg, as already found by the Examiner, discloses components of
claim 1 and its dependents. Non-Final Act. 4.
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Our decision not to enter a new ground of rejection for all claims should not
be considered as an indication of the appropriateness of further rejections or
allowance of the non-rejected claims.

ANTICIPATION
The claimed oral prebiotic edible composition is broad enough to
include prepared food products that comprise arginine in the claimed
amounts. The following food products described FoodData Central meet all
the limitations of claim 1:
1. Crackers, standard snack-type, sandwich, with peanut butter filling
(USDA, FoodData Central, published 2019) (https://fdc.nal.usda.gov/fdc-
app.html#/food-details/174984/nutrients; accessed Nov. 9, 2021)
(“Crackers”). Crackers discloses a food composition comprising 0.933
grams or 0.993 wt% arginine (reasonably believed to the naturally-occurring
free form of L-arginine), sucrose, glucose, fructose (monosaccharides and
disaccharides), and cracker, water, and carbohydrates as the carrier.
2. Formulated bar, MARS SNACKFOOD US, SNICKERS Marathon
Energy Bar (USDA, FoodData Central, published 2019)
(https://fdc.nal.usda.gov/fdc-app.html#/food-details/173136/nutrients,
accessed Nov. 9, 2021) (“Snickers”). Snickers discloses a food composition
comprising 1.67 grams or 1.67 wt% arginine (reasonably believed to the
naturally-occurring free form of L-arginine), sucrose, glucose, fructose
(monosaccharides and disaccharides), and water and carbohydrates as the
carrier.
3. Formulated bar, SLIM-FAST OPTIMA meal bar, milk chocolate
peanut (USDA, FoodData Central, published 2019)
(https://fdc.nal.usda.gov/fdc-app.html#/food-details/173139/nutrients,
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accessed Nov. 9, 2021) (“Slim-Fast”). Slim-Fast discloses a food
composition comprising 1.37 grams or 1.37 wt% arginine (reasonably
believed to the naturally-occurring free form of L-arginine), sucrose,
glucose, fructose (monosaccharides and disaccharides), and waterand
carbohydrates as the carrier.
With respect to the last clause of claim 1, because Crackers, Snickers,
and Slim-Fast are food products that require chewing, it is reasonable to
believe that they would be resident in the mouth for more than a minute,
releasing the L-arginine into the oral cavity.
Crackers, Snickers, and Slim-Fast are not described to “selectively
promote an increased concentration of selected oral microbiota to thereby
treat the allergy related respiratory condition, the selected oral microbiota
comprising Veillonella and Streptococcus.” But because Crackers, Snickers,
and Slim-Fast have the same ingredients in the same amounts as required by
claim 1, it would be reasonably expected that each of Crackers, Snickers,
and Slim-Fast possess the same activity as the claimed composition. See
Best, 562 F.2d 1255.
Pursuant to 37 C.F.R. § 41.50(b), we set forth a new ground of
rejection. The new ground of rejection is as follows:
Claim 1 is rejected under 35 U.S.C. § 102 as anticipated by Crackers,
Snickers, or Slim-Fast.
We have not reviewed the remaining claims to determine whether
these claims are obvious based on Crackers, Snickers, Slim-Fast, Mello,
Sarama, Greenberg, Bauer, or other prior art. We leave it to the Examiner to
determine the appropriateness of any further rejections based on these or
other references. Our decision not to enter a new ground of rejection for all
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claims should not be considered as an indication of the appropriateness of a
further rejection or allowance of the non-rejected claims.

CONCLUSION
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed New
Ground
1, 3, 4, 7–
18, 20–22
103 Sarama 1, 3, 4, 7–
18, 20–22

5 103 Sarama, Greenberg 5
19 103 Sarama, Bauer 19
1, 22 103 Mello 1, 22
1 102 Crackers 1
1 102 Snickers 1
1 102 Slim-Fast 1
Overall
Outcome
1, 3–5, 7–
22
1, 22

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED; 37 C.F.R. § 41.50(b)