ELORAC, INC

Patent Trials and Appeals Board

Sep 15, 2021

2020004363 (P.T.A.B. Sep. 15, 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.
14/988,482 01/05/2016 Joel E. Bernstein 41958-245559 4920
7590 09/15/2021
Joel R. Bernstein, Ph.D.
Winston Laboratories, Inc.
100 Fairway Drive, Suite 134
Vernon Hills, IL 60061
EXAMINER
MENSH, ANDREW J
ART UNIT PAPER NUMBER
3781
MAIL DATE DELIVERY MODE
09/15/2021 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 JOEL E. BERNSTEIN
____________

Appeal 2020-004363
Application 14/988,482
Technology Center 3700
____________

Before CHARLES N. GREENHUT, MICHELLE R. OSINSKI, and
JEREMY M. PLENZLER, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1–8 and 12–16.2 We have jurisdiction over the
appeal under 35 U.S.C. § 6(b). A video oral hearing was held August 23,
2021.3
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Elorac, Ltd. as the real party in
interest. Appeal Br. 2.
2 Claims 9–11 are cancelled. Appeal Br. 13 (Claims App.).
3 A transcript of the oral hearing (“Tr.”) has been entered into the record.
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THE CLAIMED SUBJECT MATTER
Claims 1 and 12 are independent. Claim 1 is reproduced below.
1. A method of packaging one or more anti-neoplastic
pharmaceutical agents for application to the surface of a
premalignant or malignant cutaneous skin lesion, the method
comprising:
(a) providing a bottle having a control-flow applicator top
and a cap;
(b) filling the bottle with a liquid formulation of the anti-
neoplastic agent; and
(c) securing the control-flow applicator top and cap to the
bottle to permit a patient to apply the liquid formulation to the
skin lesion.

EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Name Reference Date
Schwartzman US 3,565,294 Feb. 23, 1971
Luck US 4,978,332 Dec. 18, 1990

THE REJECTION
Claims 1–8 and 12–16 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Luck and Schwartzman. Final Act. 4–7.

OPINION
Claims 1–5, 7, 8, and 12–15
Appellant argues claims 1–5, 7, 8, and 12–15 as a group. Appeal
Br. 5–11. We select claim 1 as the representative claim, and claims 2–5, 7,
8, and 12–15 stand or fall therewith. 37 C.F.R. § 41.37(c)(1)(iv).
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The Examiner finds that:
Luck discloses the use of anti-neoplastic pharmaceutical agents
(col. 2, lines 7–18) for application to the surface of a
premalignant or malignant cutaneous skin lesion (abstract; col 1,
line 67–col 2, line 6), wherein a convenient means for application
of the anti-neoplastic pharmaceutical agents is provided (col 5,
lines 50–55) and filled with a liquid formulation of the
antineoplastic pharmaceutical agents to permit a patient to apply
the liquid formulation to the skin lesions (col. 4, lines 33–37;
col. 5, lines 53–57).
Final Act. 4. Although Luck teaches “[t]he drug combination[, including a
cytotoxic drug,] is applied at the region of the lesion either intralesionally by
injection or adjacent to or at the surface of the lesion, conveniently by means
of a catheter” (Luck 2:3–6) and that “[a]dministration may be by syringe,
catheter or other convenient means allowing for application of a flowable
composition at the tumor site” (id. at 5:53–55), the Examiner acknowledges
that Luck fails to disclose “providing a bottle having a control-flow
applicator top and a cap; filling the bottle with the liquid formulation; and
securing the top and cap to the bottle to permit the patient to apply the
formulation to the skin.” Final Act. 5.
The Examiner turns to Schwartzman, finding that Schwartzman
teaches:
a fluid applicator (10; abstract; Fig. 1), including packaging
medicaments within a bottle (container, 12; col. 1, lines 8–16;
col. 1, line 75–col. 2, line 21) having a control-flow applicator
top (valve assembly, 14; col. 2, lines 22–44) and a cap (16; col.
2, lines 45–48); filling the bottle (12) with the liquid formulation;
and securing the top (14) and cap (16) to the bottle (12) to permit
the patient to apply the formulation to the skin (Fig. 3; col. 1,
lines 17–47).
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Final Act. 5. Considering that Schwartzman discloses that it “is directed to a
fluid applicator especially adapted for use in applying . . . medications” and
that it “is inexpensive to manufacture, simple to use, capable of metering
fluids of various viscosities in an effective manner so that the applicator is
capable of effective use in applying medications” (Schwartzman 1:7–8,
36–39), the Examiner concludes that it would have been obvious “to modify
the undisclosed convenient means of application disclosed by Luck to be a
control flow applicator bottle, similar to that disclosed by Schwartzman.”
Final Act. 5 (citing Schwartzman 1:36–41).
Appellant questions “[w]hy would one of skill combine a ‘treatment’
invention with novelty being a combination of drugs administered in a
restricted area, with an invention relating ‘cam locking means’, without the
guidance of hindsight.” Appeal Br. 5–6. Appellant further queries “[h]ow
could one of skill seek the many missing elements in Luck . . . in the other
publications when there is no guidance in Luck to know what elements are
missing” and alleges it is “[o]nly hindsight” that would guide the person of
ordinary skill in the art to locate the “missing elements.” Id. at 6.
We look to whether the Examiner has provided “some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (cited with
approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). Here,
the Examiner reasons that one of ordinary skill in the art, recognizing that
Luck’s drug combination is to be applied at the surface of a lesion (Luck
2:3–5) and that this can be accomplished by “syringe, catheter or other
convenient means allowing for application of a flowable composition” (id. at
5:53–55), would have been led to look for other fluid applicators. Ans. 3.
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The Examiner finds that Schwartzman’s applicator “is used for the
application of a flowable composition to a desired surface.” Ans. 3. The
Examiner further points to Schwartzman’s teachings that its “applicator
provides an inexpensive to manufacture, simple to use applicator, capable of
metering fluids of various viscosities in an effective manner so that the
applicator is capable of effective use in applying medications.” Id. at 4
(citing Schwartzman 1:35–41). In our view, the Examiner articulates
persuasive reasoning based on rational underpinnings as to why it would
have been obvious to modify Luck to put its drug combination into
Schwartzman’s applicator for facilitating application of a flowable
composition at the surface of a lesion. Appellant’s queries do not
specifically address the Examiner’s reasoning set forth in the rejection or
explain adequately why the reasoning is deficient.
We are also unpersuaded by Appellant’s argument that the
Examiner’s proposed combination of Luck and Schwartzman must be based
upon impermissible hindsight. See Appeal Br. 5–6. A hindsight argument is
of no moment where the Examiner provides a sufficient reason to combine
the references. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016).
Moreover, Appellant does not identify any knowledge relied upon by the
Examiner that was gleaned only from Appellant’s disclosure and that was
not otherwise within the level of ordinary skill in the art at the time of the
invention. See In re McLaughlin, 443 F.2d 1392 (CCPA 1971) (“Any
judgment on obviousness is in a sense necessarily a reconstruction based
upon hindsight reasoning, but so long as it takes into account only
knowledge which was within the level of ordinary skill at the time the
claimed invention was made and does not include knowledge gleaned only
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from applicant’s disclosure, such a reconstruction is proper.”). Here, Luck
explicitly suggests that other applicators enabling application of flowable
compositions may be appropriate (Luck 5:53–55), and Schwartzman
explicitly suggests that its applicator is inexpensive, simple to use, capable
of metering fluids of various viscosities in an effective manner, and is
effective in applying medications (Schwartzman 1:35–41). Accordingly, we
are not persuaded that the Examiner’s rationale for combining Luck and
Schwartzman improperly used Appellant’s own teachings as a guide.
Appellant also argues that “Luck neither discloses the application of a
cytotoxic agent to the surface of a premalignant or malignant cutaneous
lesion.” Appeal Br. 7 (referring to a “discussion of the definition and
function of catheters in the record”). The Examiner responds that “Luck
discloses that the cytotoxic agent is applied at the region of the lesion either
intralesionally by injection or adjacent to or at the surface of the lesion.”
Ans. 5; Luck 2:3–5 (emphasis added). The Examiner further responds that
“Luck considers application to premalignant and malignant cutaneous
lesions, such as psoriasis, keloids, warts, melanomas, cutaneous malignant
lymphomas, solar keratosis, flat cutaneous lesions, among others.” Ans. 5
(citing Luck 1:67–2:6; 2:18–24; 5:26–37, 61–67) (emphasis added). We
determine that the Examiner’s findings regarding the application of a
cytotoxic agent to a surface of a cutaneous malignant lesion is supported by
a preponderance of the evidence.
As to the referenced “discussion of the definition and function of
catheters in the record” (Appeal Br. 7), our independent review of the record
does not identify any such discussion. Appellant advanced detailed
arguments at the oral hearing in support of the proposition that Luck cannot
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mean that its cytotoxic drug combination is to be applied at the surface of a
cutaneous lesion using a catheter or other similar type instrument.
Tr. 3:3–7:2, 9:13–14. Such detailed argument, and any extrinsic evidence
referenced in support of such argument, has not been presented to the
Examiner in the Appeal, according to the record before us. As the argument
was not properly before the Examiner, such that we might have had the
benefit of the Examiner’s views on the argument and evidence in reaching
our decision on this appeal, we consider only those arguments presented by
Appellant in the briefs, and we do not find the briefing persuasive of error.
See 37 C.F.R. § 41.47(e)(1): “At the oral hearing, appellant may only rely on
Evidence that has been previously entered and considered by the primary
examiner and present argument that has been relied upon in the brief or reply
brief except as permitted by paragraph (e)(2) of this section.” Paragraph
(e)(2) of the relevant section provides: “Upon a showing of good cause,
appellant and/or the primary examiner may rely on a new argument based
upon a recent relevant decision of either the Board or a Federal Court.”
Paragraph (e)(2) is not applicable in the present case, nor has Appellant
alleged that a circumstance of good cause is present here. Moreover, we
note that Appellant has acknowledged that application of cytotoxic agents to
the surface of skin is known. Tr. 8:18–24, 10:1–5; see also Spec. ¶¶ 3–4.
At the oral hearing, Appellant advanced another new argument that
does not appear in the briefing. More particularly, Appellant argued that
although cytotoxic products have been marketed “for over 70 years,” “no
one has thought about putting it in . . . this kind of applicator system where a
patient won’t have to touch the cytotoxic product.” Tr. 10:13–17. Again,
we note that because the argument was not properly before the Examiner in
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the briefing, we do not consider it. Moreover, to the extent Appellant may
be suggesting that the use of its applicator is a solution of a long-felt need,
Appellant must provide objective evidence that is factually supported by an
appropriate affidavit or declaration for such a suggestion of “secondary
considerations” to have probative value. Graham v. John Deere Co., 383
U.S. 1 (1966); In re Schulze, 346 F.2d 600, 602 (CCPA 1965).
Appellant additionally argues that Luck does not disclose “any means
of application of any agent without the patient’s hands having physical
contact with the liquid formulation.” Appeal Br. 7. The Examiner responds
that although the Examiner “maintains that both Luck and Schwartzman
would not require the patient’s hands having physical contact with the liquid
formulation, this limitation was removed from the claims.” Ans. 5. We
agree with the Examiner that Appellant’s argument regarding the prior art’s
purported lack of a means of application without the patient’s hands having
physical contact with the liquid formation, is not commensurate with the
scope of independent claims 1 and 12, which do not require such a feature.
See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (noting that it is well
established that limitations not appearing in the claims cannot be relied upon
for patentability).
Appellant further argues that “Schwartzman calls for ‘an applicator
for use in combination with a squeezable tube’ (Abstract lines 1 and 2), not a
rigid plastic or glass bottle as called for in the pending patent application.”
Appeal Br. 8 (emphasis omitted). More particularly, Appellant asserts that
Examiner-identified element 12 in Schwartzman is not a bottle, but a
“container.” Id. Appellant points to Schwartzman’s teachings of the
applicator’s use in combination with “a squeezable container such as a
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plastic tube or the like” (id. (quoting Schwartzman 1:12–16)) and the
container 12 being “in the form of an elongated cylindrical tube 18 molded
out of any suitable plastic material as is generally used for such packages
and is resilient, deformable, flexible, and squeezable” (id. (quoting
Schwartzman 2:4–9)). Appellant maintains that the claims call for “a
‘bottle,’” and “[a] bottle is not equivalent to a plastic squeezable tube as
related in Schwartzman.” Id. at 9 (emphasis omitted).
The Examiner responds that “[t]he claims do not require the bottle to
be rigid, as argued; claim 2 merely calls for a bottle which is either plastic or
glass.” Ans. 5. The Examiner further responds that “Cambridge Dictionary
defines a bottle as ‘a container for liquids, usually made of glass or plastic,
with a narrow neck’” and “Dictionary.com defines a bottle as ‘a container,
typically made of glass or plastic and with a narrow neck, used for storing
drinks or other liquids.’” Id. at 6. The Examiner then points to
“Schwartzman’s plastic tube referenced as numeral 312 in Figure 9 [as]
clearly show[ing] a narrow necked container which one having ordinary skill
in the art would recognize as being a bottle.” Id. Appellant has not
explained adequately why Schwartzman’s tube, depicted as having a narrow
neck (Schwartzman Fig. 9) and described as being made of plastic and
capable of metering fluids of various viscosities (id. at 1:36–37; 2:4–6)
cannot reasonably be considered a “bottle” in accordance with the
Examiner’s proffered definitions. Although Appellant asserts that
“[c]ommon sense knows a ‘plastic tube’ is not a ‘bottle’ as in the pending
claims” (Appeal Br. 9), we note that “[a]bsent an express definition in their
specification, the fact that appellants can point to definitions or usages that
conform to their interpretation does not make the PTO’s definition
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unreasonable when the PTO can point to other sources that support its
interpretation.” In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997).
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s determination that the combination of Luck and
Schwartzman renders obvious the subject matter of independent claim 1.
Accordingly, we sustain the rejection of claims 1, and claims 2–5, 7, 8, and
12–15 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over Luck
and Schwartzman.
Claims 6 and 16
Dependent claims 6 and 16 recite that the applicator top (claim 6) or
package (claim 16) “further comprises a concave cover pad constructed of
porous material such that when the bottle is inverted and the cover pad is
pressed against a surface, the anti-neoplastic fluid will flow out of the bottle
through one or more pores of the cover pad to contact the surface of the
lesion.” Appeal Br. 13–14 (Claims App.). The Examiner finds that
Schwartzman teaches such a concave cover pad and points to the “outwardly
curved and substantially hemispherical surface, 66 of cover, 36[] constructed
of porous material such that when the bottle (12) is inverted and the cover
pad (36) is pressed against a surface, the fluid will flow out of the bottle (12)
through one or more pores of the cover pad to contact the target surface.”
Final Act. 6 (citing Schwartzman Figs. 1, 2; 2:17–21, 35–45).
Appellant argues that “[e]lement 36 in Schwartzman is not defined as
a ‘concave cover pad,’ rather as a ‘cover.’” Appeal Br. 9 (citing
Schwartzman 2:17). The Examiner responds the “element 66 of
Schwartzman [equates] to the claimed concave cover pad” and
“Schwartzman denotes element 66 as ‘an outwardly curved and substantially
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hemispherical surface of the cover.’” Ans. 6; Schwartzman 2:44–45.
Appellant essentially argues only that Schwartzman does not call or describe
its “cover” a concave cover pad (Appeal Br. 9), but does not explain
adequately why such a curved, hemispherically shaped element made of
polyurethane foam cannot reasonably be considered the claimed concave
cover pad in accordance with the Examiner’s finding. A reference need not
describe a limitation in haec verba. See In re Bode, 550 F.2d 656, 660
(CCPA 1977).
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s determination that the combination of Luck and
Schwartzman renders obvious the subject matter of dependent claims 6 and
16. Accordingly, we sustain the rejection of claims 6 and 16 under
35 U.S.C. § 103(a) as unpatentable over Luck and Schwartzman.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–8, 12–16 103(a) Luck, Schwartzman 1–8, 12–16

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