Ex Parte Tung

Patent Trial and Appeal Board

Dec 18, 2017

10996071 (P.T.A.B. Dec. 18, 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.
010118.00017 5717
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
10/996,071 11/24/2004
128386 7590
Key IP Law Group, PLLC
1934 Old Gallows Road
Suite 350
Vienna, VA 22182
Ming S. Tung
12/18/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MING S. TUNG1
Appeal 2016-006625
Application 10/996,071
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a tooth whitening and remineralization kit. The Examiner rejects the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant, the real party in interest is ADA Foundation.
Appeal Br. 3.
Appeal 2016-006625
Application 10/996,071
STATEMENT OF THE CASE
Claims 10-12 and 50-53 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief.2
Appellant requests review of the following rejections made by the
Examiner:
I. Claims 10-12 and 50-52 under 35 U.S.C. § 103(a) as
unpatentable over Winston3 in view of Lee4 as evidenced by
Montgomery.5 Appeal Br. 9.
II. Claims 10-12 and 50-53 under 35 U.S.C. § 103(a) as
unpatentable over Winston in view of Orlowski.6 Id.
2 The Appeal Brief contains a Declaration by Dr. Tung, signed January 15,
2015 (“Tung Declaration”) that was submitted with the Response after Final
Office Action on January 21, 2015. In the subsequent Advisory Action
issued on March 13, 2015, the Examiner noted that the Declaration was not
entered. The Examiner’s reason for not entering the Declaration is that the
rejection based on Winston is not new but instead is a reinstated rejection
that was originally presented in an Office Action mailed October 16, 2008.
See Ans. 7. We note that a petition under 37 C.F.R. § 1.181 was filed on
August 5, 2015, requesting entry of the Tung Declaration, but the petition
was dismissed as being untimely filed. See Pet. Decision, mailed Aug. 26,
2015. Another petition was filed under 37 C.F.R. § 1.183 on Sept. 21, 2015,
requesting waiver of the rules to allow entry of the Tung Declaration, but
this petition was also dismissed by the Office of Petitions citing that the
petition was not timely filed. See Pet. Decision mailed Oct. 7, 2015.
Because the Tung Declaration has not been entered and considered by the
Examiner we will also not address arguments directed to the Tung
Declaration in this opinion. See 37 C.F.R. § 41.37(c)(2) (2011) (“A brief
shall not include any new or non-admitted amendment, or any new or non-
admitted affidavit or other Evidence.”).
3 Winston et al., US 6,303,104 Bl, issued Oct. 16, 2001 (“Winston”).
4 Lee et al., US 6,120,754, issued Sept. 19, 2000 (“Lee”).
5 Montgomery, US 6,331,292 Bl, issued Dec. 18, 2001 (Montgomery”)
6 Orlowski et al., US 6,365,134 Bl, issued Apr. 2, 2002 (“Orlowski”).
2
Appeal 2016-006625
Application 10/996,071
I. Obviousness over Winston and Lee as evidenced by Montgomery
Claim 10, the only independent claim, is directed to a kit and is
reproduced below.
Claim 10: A tooth whitening and remineralizing kit comprising:
(a) a pH-control composition having an alkaline pH and
comprising a soluble calcium salt, and;
(b) a stabilized peroxide composition comprising a
soluble peroxide and a soluble orthophosphate salt, wherein
said stabilized peroxide composition has an acidic pH and
further comprises a fluoride ion source, and wherein said
soluble orthophosphate salt is present in an amount effective for
stabilization of the soluble peroxide against degradation over
long-term storage.
Appeal Br. 39 (Claims Appendix).
The claim is directed to a kit “comprising” two components:
Component A—encompasses a mixture containing calcium salt and a pH-
control composition; and Component B—encompasses a mixture containing
peroxide, orthophosphate, and fluoride. “‘Comprising’ is a term of art used
in claim language which means that the named elements are essential, but
other elements may be added and still form a construct within the scope of
the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir.
1997). Because of the “comprising” language as recited in the claim the
components listed in the body of the claim are required but can include
additional ingredients even in large amounts and still be encompassed by the
claim.
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find that the preponderance of evidence on this
record supports the Examiner’s conclusions that the subject matter of
Appellant’s claims 10-12 and 50—53 is unpatentable over the combination of
3
Appeal 2016-006625
Application 10/996,071
Winston and Lee as evidenced by Montgomery. Accordingly, we sustain the
Examiner’s rejections of each of these claims for the reasons set forth in the
Answer (Ans. 2-4 and 6—31) which we incorporate herein by reference in its
entirety. We address Appellant’s contentions below:
Appellant contends that “Winston teaches away from the use of
peroxide-based bleaching agents for whitening teeth,” because it was known
that peroxide compounds in the presence of abrasive undergo “premature
decomposition.” Appeal. Br. 15; see id. at 19 & 26; see also id. atl6 (“The
silica abrasives used by Winston are not compatible with peroxide; such
abrasives will destabilize the peroxide in storage”), see id. at 32 (citing
Prencipe7 in support); see Reply Br. 5.
We recognize, but are not persuaded by, Appellant’s contention that
Winton’s disclosure teaches away from including peroxide in the abrasive
composition. Appellant’s reliance on the teaching Prencipe to support this
position is misplaced. We understand that Prencipe teaches that “[djentifrice
whitening products formulated with peroxy compounds normally do not
contain abrasive polishing agents as such materials activate the rapid
decomposition of the proxy compound[]” decreasing the whitening ability
and producing gas that could result in swelling or bursting of tubes.
Prencipe2: 41—45. Prencipe, however, teaches formulations that overcome
the negative effects of peroxide when combined with abrasive by teaching
that the use of metal ion free peroxide compounds. Prencipe 3:39-44. Thus,
Prencipe teaches that abrasive formulations containing peroxide compounds
are possible as long as the peroxide compound is metal ion free. Therefore,
7 Prencipe et al., US 5,256,402, issued Oct. 26, 1993 (“Prencipe”), cited by
Appellant. See Appeal. Br. 32; see Reply Br. 4.
4
Appeal 2016-006625
Application 10/996,071
we do not agree with Appellant’s contention that Winston would lead away
from combining a peroxide compound with an abrasive because it was
already known in the art how to overcome issues of peroxide degradation
when mixed with abrasive agents.
We are also not persuaded by Appellant’s contention that the teaching
in Prencipe is limited to the specific embodiment taught, namely using
dicalcium phosphate-dihydrate and anhydrous dicalcium or calcium
pyrophosphate as the abrasive. See Reply Br. 4. Here, Prencipe explains
that “[a] drawback to the use of whitening products which are formulated
without abrasives is that, in addition to having a slow bleaching action, the
products are not effective in stain removal.” Prencipe 2:55—58. Although,
Prencipe exemplifies the use of dicalcium phosphate-dihydrate and
anhydrous dicalcium or calcium pyrophosphate as providing proxide
stability that also functions as an abrasive there is no reason to think this is
the only abrasive contemplated. Id. 4:27—37. Indeed, the teaching in
Prencipe is more generic in that the reference makes it clear that bleaching
action alone without more would be slow to work and thereby motivate the
inclusion of an abrasive with a product that is scrubbed onto teeth for the
purpose of cleaning. Id. 2:55—68. Further, the Examiner suggests that “the
abrasive may [just as well] be added to the other part [of Winston’s
composition] if there was an issue with decomposition” of the peroxide.
Ans. 31. In other words, the Examiner’s position is that the abrasive can be
placed into either component of the two component system.
We are not persuaded by Appellant’s contention that “Winston’s
disclosed whitening agent formulation avoids all of the well-known
disadvantages of hydrogen peroxide teeth bleaching.” Appeal. Br. 19.
5
Appeal 2016-006625
Application 10/996,071
Winston teaches that the oral product may contain “conventional
additives” such as “coloring or whitening agents.” Winston 8:6—13. We
find no error with the Examiner’s conclusion that based the combination of
Winston and Lee “[i]t would have been obvious to one of ordinary skill in
the art to have added hydrogen peroxide as the whitening agent [and pH
adjusting agent] to the part comprising phosphate ions in the compositions of
the Winston et al. motivated by the desire to acidity the phosphate salt
comprising part to insure its stability and because hydrogen peroxide is
stable under acidic conditions.” Ans. 4, see id. 31; see also Montgomery
2:25—26. (“[HJydrogen peroxide becomes markedly less stable as the pH
increases.”). The Examiner recognizes, and we agree, that Winston does not
specifically recite the pH of either component A or component B but teaches
that mixed together the aqueous solution has a pH range from 4—10 (see
Winston 4:1—11), an preferably between 4.5 and 7.0. Id. 18: 61—62 (claim
3); see Ans. 13. The Examiner explains that “the [orthojphosphate part [of
Winston’s composition in Table 1] comprises phosphoric acid, a strong acid.
Therefore one of ordinary skill in the art would conclude that the phosphate
containing component is more than likely acidic. Further when looking at
the Examples to which Appellant refers, there appear to be no acidic
components in the calcium containing part [of Winston’s formulation].”
Ans. 15.
The Examiner finds that “Lee discloses that peroxide provides acidity
to the composition.” Ans. 16; see also Lee 4:20-21 (“Hydrogen peroxide
and phosphoric acid are the preferred substances” for adjusting pH levels).
We find no error with the Examiner’s reliance on Lee’s teaching that the use
of hydrogen peroxide and phosphoric acid in conjunction are known
6
Appeal 2016-006625
Application 10/996,071
components for adjusting the pH of dental formulations. Thus, when
combining Winston and Lee, the Examiner notes that “the amount of
phosphate [used] in Winston[’s compositions] overlaps that of the phosphate
of the instant invention and therefore should have the ability to stabilize
peroxide.” Ans. 4.
Winston discloses that anhydrous dicalcium phosphate abrasive and a
silica abrasive are used in the composition to increase the stain removal
properties. See Winston 4:1—21. The Examiner’s rejection adds hydrogen
peroxide as a pH adjusting agent to Winston’s orthophosphate containing
composition. See Ans. 4. Lee teaches producing dental treatment
formulation that rely on using “hydrogen peroxide and phosphoric acid” for
adjusting pH levels of a dental composition. Lee 4:20-21. As explained by
the Examiner hydrogen peroxide and peroxide compounds are known art
recognized whitening agents — the addition of hydrogen peroxide even for
the purpose of adjusting pH in Winton’s formulation would provide some
whitening effect in addition to the abrasive found in the composition that
helps scrub the teeth. It is important to point out that the present claims as
written are broad enough to include additional whiting agents such as the
abrasives in Winston and are not limited to a particular whitening effect or a
particular peroxide concentration.
Appellant contends that “[o]ne skilled in the art knows that hydrogen
peroxide is not suitable for acidifying the phosphate component of Winston
to a pH range of 2.5 to 5.5, or even less than 7.” Reply Br. 7.
We are not persuaded. We agree with the Examiner that “Lee
discloses combinations of phosphoric acid and hydrogen peroxide.
Therefore when adding a hydrogen peroxide whitening agent to the
7
Appeal 2016-006625
Application 10/996,071
compositions of Winston, one [of ordinary skill in the art] would add it to
the phosphate part because the phosphate part [already] has phosphoric acid
and hydrogen peroxide is [known to be] stable in acidic conditions.” Ans.
16.
Appellant has not met their burden of showing that the Examiner
erred in rejecting claims, or otherwise rebutted the Examiner’s cogent
response in the Answer’s “Response to Arguments” (Ans. 6—24) concerning
the combination of Winston and Lee. Accordingly, we affirm the rejection
of claim 10 under 35 U.S.C. § 103(a) as being obvious. As claims 11,12
and 50-52 have not been argued separately they fall with claim 10.
37 C.F.R. §41.37(c)(l)(iv).
II. Obviousness over Winston and Orlowski
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find that the preponderance of evidence on this
record supports the Examiner’s conclusions that the subject matter of
Appellant’s claims 10-12 and 50—53 is unpatentable over the combination of
Winston and Orlowski. Accordingly, we sustain the Examiner’s rejections
of each of these claims for the reasons set forth in the Answer (Ans. 5—6 &
24—31) which we incorporate herein by reference in its entirety. For
emphasis only, we provide the following in response to some of Appellant’s
arguments:
Appellant contends that “modification of Winston with Orlowski's
whitening agent means Winston’s silica abrasives will destabilize Orlowski's
peroxide.” Appeal Br. 30.
8
Appeal 2016-006625
Application 10/996,071
We recognize, but are not persuaded by, Appellant’s contention that
the presence of an abrasive in Winton would teach away from including
Orlowski’s peroxide into the composition. Prencipe teaches that abrasive
formulations containing peroxide compounds are possible as long as the
peroxide compound is a metal ion free. See Prencipe 3:39-44. As discussed
above, we do not agree with Appellant’s position that Prencipe’s teachings
are limited to the preferred embodiments. Therefore, we are not persuaded
by Appellant’s contention that the art would lead away from combining a
peroxide compound with an abrasive.
Winston teaches that the oral product may contain “conventional
additives” such as “coloring or whitening agents.” Winston 8:6—12.
Orlowski teaches a teeth whitening composition and acknowledges that
“hydrogen peroxide is preferred for its faster action, while carbamide
peroxide based formulations offer advantages in terms of greater storage
stability.” Orlowski 1:38-40. Orlowski teaches that the stability of a
peroxide is improved if stored at low pH in the range of 3—4.5. Id. 44-45.
Orlowski teaches adding the peroxide component into the part of the system
that does not contain calcium. See Orlowski Examples 1—5. Therefore,
when adding the additional whiting agent to Winston’s composition, as
suggested by Winston (see Winston 8:6—12), it would be reasonable based
on the teachings of Orlowski to add the whitening agent to Winston’s non­
calcium containing component. After all, Orlowski recognizes that the
stability of peroxide is improved if the peroxide whitening agent is stored at
low pH in the range of 3—4.5. Orlowski 1:44-45. Based on the combined
teachings we agree with the Examiner that “Winston discloses whitening
agent additives . . . and Orlowski provide[s] motivation as to why one of
9
Appeal 2016-006625
Application 10/996,071
ordinary skill in the art would want to add peroxides to the compositions of
Winston with a reasonable expectation of success.” Ans. 27.
Appellant has not met their burden of showing that the Examiner
erred in rejecting the claims, or otherwise rebutted the Examiner’s cogent
response in the Answer’s “Response to Arguments” section (Ans. 24—31)
concerning the combination of Winston and Orlowski. Accordingly, we
affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as being obvious.
As claims 11,12 and 50-53 have not been argued separately they fall with
claim 10. 37 C.F.R. § 41.37(c)(l)(iv).
DECISION
We affirm the rejection of all claims.
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
10