Ex Parte Hered

Board of Patent Appeals and Interferences

Jun 19, 2009

10444632 (B.P.A.I. Jun. 19, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT W. HERED
__________

Appeal 2007-0040211
Application 10/444,632
Technology Center 3700
__________

Decided:2 June 19, 2009
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 “Glenn Rothman is the sole owner and real party in interest in the subject
application, by virtue of an Assignment from the Nemours Foundation to
Glenn Rothman” (App. Br. 2).
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2007-004021
Application 10/444,632

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
and kits for placing medical information on patients’ bodies. The Examiner
has rejected the claims as containing new matter and being obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse the new matter rejection, but affirm the obviousness
rejection.
STATEMENT OF THE CASE
Claims 1-5, 7-11, and 13-20 are pending, stand rejected, and are on
appeal (App. Br. 3). Claim 1 is representative and reads as follows:
1. A method for conveying medical procedure patient information
comprising:
identifying a selected patient information;
selecting a sterile stamp wherein the stamp has a stamp surface
and the stamp surface is treated with an ink; and
applying the stamp surface to a patient while the patient is
conscious at a region on the patient to be subjected to a medical
procedure wherein the selected patient information conveyed by the
stamp relates to the region on the patient and wherein the stamp
includes verbiage identifying a predetermined location on a patient’s
body where a medical procedure is to be performed.

The Examiner cites the following documents as evidence3 of
unpatentability:
Gallub US 4,183,353 Jan. 15, 1980
d’Arbelles et al. US 5,357,861 Oct. 25, 1994
d’Arbelles US 6,286,682 B1 Sep. 11, 2001
Passmore US 6,436,105 B1 Aug. 20, 2002

3 While the Examiner states that no evidence is relied on (Ans. 4), the
Examiner clearly cites four references in support of the obviousness
rejections (see Ans. 6, 11).
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The following rejections are before us for review:
Claims 1-5, 7-11, and 13-20 stand rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description requirement
(Ans. 5-6).
Claims 1-4, 7-10, and 13-20 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over d’Arbelles ‘861 in view of Passmore and
d’Arbelles ‘682 (Ans. 6-11).
Claims 5 and 11 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over d’Arbelles ‘861 in view of Passmore and d’Arbelles ‘682
as applied to claims 1 and 7, further in view of Gallub (Ans. 11).
WRITTEN DESCRIPTION (NEW MATTER)
ISSUE
The Examiner finds that the claims contain “subject matter which was
not described in the specification in such a way as to reasonably convey to
one skilled in the relevant art that the inventor(s), at the time the application
was filed, had possession of the claimed invention” (Ans. 5). Specifically,
the Examiner urges that “independent claims 1, 7, 13, 19 and 20 all contain
recitations of ‘while the patient is conscious’ (claims 1, 7 and 19) and
‘conscious human’ (claims 13 and 20) which are not supported by the
specification” (id.).
Appellant contends that paragraphs [004], [017], [034], and [036] of
the Specification provide support for the claim recitations at issue (App. Br.
5-6). Specifically, Appellant argues, the Specification’s disclosures of
applying stamps to uncooperative medical patients “clearly implies that
Appellant’s invention is intended to be directed toward a conscious patient
in that an unconscious patient cannot perform resistive action” (id. at 5).
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The Examiner responds that “if anything,” the cited portions of the
Specification “point[] to the benefits of application [of the stamp] during
unconsciousness. At the very least, no support of the recited ‘conscious
patient’ or ‘while the patient is conscious’ can be gleaned from this passage
by one of ordinary skill in the art” (Ans. 13).
In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether the Examiner erred in finding
that the Specification fails to provide adequate support for the recitations
“applying the stamp surface to a patient while the patient is conscious” in
method claims 1, 7, and 19, and the recitations “ink . . . compatible with
application to a conscious human” in kit claims 13 and 20.
FINDINGS OF FACT (“FF”)
1. The Specification discloses that “[w]rong site surgery is a recognized
medical problem. . . . Medical facilities have developed various marking
procedures. However, there is no consistent system of marking location of
surgery on surgical patients and many of the presently used methods suffer
from legibility deficiencies, reliability issues, and/or inconsistency
deficiencies” (Spec. [003]).
2. The Specification states:
[S]ystems such as temporary tattoo systems have been
proposed. (See: Berryman, et al. U.S. Patent Application
2002/0114764A1 and 2002/0164285A1)[.] However, applying
tattoos while retaining the integrity of the tattoo is often
problematic. Additionally, applying tattoos to some body sites
such as the face of an uncooperative young child may be
extremely difficult if not impossible. Further, the ability to
remove temporary tattoos, make them susceptible to removal or
defacing during surgical preparation procedures and/or to
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inadvertent removal or defacing as a result of patient
movements.

(Spec. [004].)
3. The Specification states:
The present invention involves a method for conveying
patient information related to a medical procedure using a
stamp system. The method may be used for patients of any age
and is particularity [sic] well suited for use with infants or
young children in which body areas designated for a medical
procedure may be small and/or for patients who are not
particularly cooperative either intentionally or inadvertently
with medical personnel. A kit suitable for performing the
method is also described.

(Spec. [017].)
4. The Specification states:
The potential for smearing and reduced legibility may
also be minimized by the method of the invention. Applying
the stamp in a single quick motion facilitates marking young
children, and incapacitated persons who may either
intentionally or inadvertently fail to cooperate with and/or resist
the attempts of medical personnel to make a marking. The
single quick motion of applying a stamp provides advantages
over applying a temporary tattoo which must be positioned and
adhered to the surface of the skin without folding and without
gaps where the tattoo is not adhered to the skin.

(Spec. [034].)
5. The Specification states:
The method of the invention avoids the problem of
transferability inherent to the use of adhesive stickers for body
site markings. Young children have been known to remove
stickers and to move body site identification stickers to
incorrect sites on their bodies.

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(Spec. [036].)
PRINCIPLES OF LAW
As stated in TurboCare Div. of Demag Delaval Turbomachinery
Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
subject matter on the application filing date. When the applicant
adds a claim or otherwise amends his specification after the
original filing date . . ., the new claims or other added material
must find support in the original specification.

The test for determining whether a specification is sufficient to
support a particular claim “is whether the disclosure of the application relied
upon ‘reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter.’” Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983)).
Thus, “[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA
1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).
ANALYSIS
We agree with Appellant that the Examiner erred in finding that the
Specification fails to provide adequate support for the recitations at issue.
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The Specification states that the invention is “a stamp system” that is
“particularity well suited . . . for patients who are not particularly
cooperative either intentionally or inadvertently with medical personnel”
(Spec. [017] (FF 3)). The Specification further states that “[a]pplying the
stamp in a single quick motion facilitates marking young children, and
incapacitated persons who may either intentionally or inadvertently fail to
cooperate with and/or resist the attempts of medical personnel to make a
marking” (Spec. [034] (FF 4)).
Thus, the Specification might not provide word-for-word support for
applying the stamp to a conscious person. However, a patient who resists or
is intentionally uncooperative with medical personnel would by necessity be
conscious. We therefore agree with Appellant that the Specification would
have conveyed to a person of ordinary skill in the art that Appellant
possessed processes including the step of “applying the stamp surface to a
patient while the patient is conscious” as recited in claims 1, 7, and 19, and
kits with “ink . . . compatible with application to a conscious human” as
recited in claims 13 and 20.
Accordingly, we reverse the Examiner’ rejection under 35 U.S.C. §
112, first paragraph.
OBVIOUSNESS -- CLAIMS 1-4, 7-10, and 13-20
ISSUE
Claims 1-4, 7-10, and 13-20 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over d’Arbelles ‘861 in view of Passmore and
d’Arbelles ‘682 (Ans. 6-11).
The Examiner cites d’Arbelles ‘861 as disclosing a method having the
basic steps claimed, but concedes that d’Arbelles does not “explicitly recite
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that the stamp is sterile and additionally, fail[s] to disclose that the verbiage
identifies a predetermined location on a patient's body where a medical
procedure is to be performed. Finally, d’Arbelles [‘861] fail[s] to explicitly
recite that the stamp is applied when the patient is conscious” (Ans. 7).
The Examiner cites Passmore as disclosing “that it is extremely well
known to provide skin marking devices that are sterile, including sealing the
device in a sterile package in order to assure a sterile surgical environment”
(id.). The Examiner cites d’Arbelles ‘682 as disclosing a medical alert
message kit for applying patient-related information, such as the surgical
operative site, to a patient’s skin (id.).
Based on these teachings, the Examiner concludes that a person of
ordinary skill in the art would have considered it obvious “to modify the
invention of d’Arbelles [‘861], as is well known in the art and taught by
Passmore, to provide a sterilized stamp device and stamp kit in order to
assure a sterile surgical environment” (id. at 8). The Examiner further
reasons that an ordinary artisan would have been motivated, “as taught by
d’Arbelles [‘682], to provide verbiage in order to identify a predetermined
location on a patient’s body where a medical procedure is to be performed,”
and to “apply the stamp to a conscious (i.e., capable of communicating) or
unconscious patient in order to emphasize previously performed medical
procedures and information concerning the patient's health or medical
status” (id.).
Appellant contends that “the Examiner has failed to establish that
there is a suggestion in any of the references (or elsewhere in the prior art),
to combine or modify the references to achieve Appellant’s claims. Thus,
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the Examiner has failed to establish a prima facie case of obviousness”
(App. Br. 6).
Specifically, Appellant argues, because Passmore’s device “involves a
needle that penetrates the patient’s skin, the device obviously needs to be a
disposable sterile device. In contrast, the medical stamp systems disclosed
in d’Arbelles [‘861] and d’Arbelles [‘862] do not involve apparatus or
devices which penetrate the skin” (id. at 9).
Appellant urges that “there is [therefore] no need for such devices to
be disposable and sterile and it would not be obvious to one of ordinary skill
in the art to necessarily make such stamping devices disposable and sterile
simply by viewing the Passmore reference” (id.). Thus, Appellant argues,
“[t]he desirability of modifying the d’Arbelles devices to be disposable and
sterile devices is not suggested by the prior art” (id.).
Appellant concludes that, based on a preponderance of the evidence,
“the Examiner has failed to meet his burden of persuasion. The Examiner
did not identify any expressed or implied suggestion in the Passmore and/or
d’Arbelles references (or anywhere else) to combine or modify the
references” (id. at 10). Moreover, Appellant urges, the reasoning provided
by the Examiner for providing a sterile stamp is not a “‘convincing line of
reasoning’” because “it was shown that there is no need to sterilize the
devices used in [the d’Arbelles references] because the devices did not
penetrate the skin and are not necessarily used in a surgical environment”
(id.). Instead, Appellant concludes, “the Examiner's suggestion and
modification of the combined references resulted in quintessential hindsight
reconstruction” (id.).
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In view of the positions advanced by Appellant and the Examiner, the
issue with respect to this rejection is whether the Examiner erred in
concluding that a person of ordinary skill in the art, advised by the
d’Arbelles references of the desirability of using stamps to place medical
information on the surface of a patient’s skin, and advised by Passmore of
the desirability of using sterile needles to place medically related markings
in a patient’s skin, would have considered it obvious in view of the cited
references’ teachings to use sterile stamps to place medical information on
the surface of a patient’s skin.
FINDINGS OF FACT
6. Claim 1 recites a method for conveying patient-related medical
procedure information. The method includes the steps of identifying
selected patient information, selecting a sterile stamp with an ink-treated
surface, and applying the stamp surface to a conscious patient at a region on
a patient to be subjected to a medical procedure.
Claim 1 requires the information conveyed by the stamp to relate to
the stamped region on the patient, and also requires the stamp to include
verbiage identifying a predetermined location on the patient’s body where a
medical procedure is to be performed.
7. D’Arbelles ‘861 discloses “an apparatus and method primarily
developed for the purpose of marking a patient with an intended course of
medical action or inaction, or any medical message that may be appropriate”
(d’Arbelles ‘861, col. 1, ll. 31-35).
8. The marking device used by d’Arbelles ‘861 is a stamp that applies
indelible ink to a patient’s body (d’Arbelles ‘861, col. 5, ll. 41-42).
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Thus, for example, if a patient diagnosed with a condition having little
chance of survival elects to forego extraordinary medical procedures, the
physician can stamp the patient “on the chest over the heart with the indicia
of the caduceus as well as the DNR designation, Do Not Resuscitate, as well
as the MyWil designation to indicate such to be the will, intention and desire
of the patient as given directly or through the legal guardian” (id. at col. 5, ll.
43-48).
9. Passmore discloses “a disposable sterile skin-marking device that
carries a cartridge of sterile marking agent and uses a needle to apply the
marking agent beneath one or more layers of the skin surface” (Passmore,
col. 1, l. 67 through col. 2, l. 3).
Passmore discloses that such “[m]arkings, also often referred to as
tattoos, are typically applied to the skin of a patient in preparation for
radiation therapy or other medical treatment, as a means of clearly
delineating the location of treatment set-up points” (id. at col. 1, ll. 12-15).
10. Regarding skin-penetrating tattoo-type medical markings, Passmore
discloses that, “[w]hen marking the skin in this way, it is critical that the
marking agent, such as India ink, as well as the needle tip be sterile”
(Passmore, col. 1, ll. 21-23). Furthermore, “it is highly desirable to have a
disposable needle, to eliminate the possibility of passing pathogens from one
person to another and to eliminate the need for sterilizing the needles” (id. at
col. 1, ll. 24-27).
11. D’Arbelles ‘682 discloses “a one-time use semi-permanent skin
marker in the form of an adhesive substrate (similar to temporary tattoos) for
various messages, such as for pre-existing medical conditions or advance
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directives regarding certain medical decisions” (d’Arbelles ‘682, col. 1, ll.
54-58).
D’Arbelles ‘682 states that the medical stamp emblems “can be used
by a physician or other authorized personnel to allow a patient’s body to
communicate directions for any medical action or inaction, or medical
message that the physician, medical staff person, or patient wishes to
emphasize” (id. at col. 1, ll. 58-62).
12. D’Arbelles ‘682 discloses that, “[f]or example, the messages on the
temporary medical stamp emblems may include, but are not limited to,
ORGAN DONOR, DO NOT RESUSCITATE, ALLERGY ALERT,
OPERATIVE SITE, SEIZURES, PACEMAKER, DIABETIC,
HEART/LUNG/KIDNEY TRANSPLANT, BLOOD TYPE, ON
BLOOD THINNER, and the like” (d’Arbelles ‘682, col. 2, ll. 12-17).
13. D’Arbelles ‘682 describes the application process as follows:
Before the application process is initiated, the area on the skin
where the temporary medical stamp emblem 10 is to be placed
is cleaned with an appropriate substance such as alcohol 26,
dried, and substantially free of hair. . . . After the skin has been
prepared, the person applying the emblem will remove the
plastic protection sheet 14, being very careful not to touch the
emblem 10 itself after the plastic has been removed. The
emblem 10 should be placed on the prepared skin face down
with firm pressure applied. Gauze 28, or a sponge, should then
be saturated with water (at room temperature), and placed over
the emblem 10 until thoroughly moistened, again applying firm
pressure over the entire area. Sterile 4x4 gauze and sterile
water should be used to prevent any untoward effects, i.e.
infection. After waiting the appropriate time, about 30 seconds
in most instances, the paper backing 12 may be removed by
sliding or peeling it away from the emblem 10. The emblem
and skin should then be rinsed with water and gently smoothed
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into place. The emblem 10 is generally dry in one to two
minutes, and the process is complete.

(D’Arbelles ‘682, col. 4, ll. 44-67.)
PRINCIPLES OF LAW
As the Supreme Court pointed out in KSR Int' l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
While holding that some rationale must be supplied for a conclusion
of obviousness, the Supreme Court nonetheless rejected a “rigid approach”
to the obviousness question, and instead emphasized that “[t]hroughout this
Court’s engagement with the question of obviousness, our cases have set
forth an expansive and flexible approach . . . .” Id. at 415. The Court also
rejected the use of “rigid and mandatory formulas” as being “incompatible
with our precedents.” Id. at 419; see also id. at 421 (“Rigid preventative
rules that deny factfinders recourse to common sense, however, are neither
necessary under our case law nor consistent with it.”).
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The Court thus reasoned that the analysis under 35 U.S.C. § 103 “need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418; see
also id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
The Court further reasoned that it is obvious to choose from among
known solutions to prior art problems:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id.
Regarding hindsight reasoning, the Court stated that “[a] factfinder
should be aware, of course, of the distortion caused by hindsight bias and
must be cautious of arguments reliant upon ex post reasoning. Rigid
preventative rules that deny factfinders recourse to common sense, however,
are neither necessary under our case law nor consistent with it.” Id.
(citations omitted).
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner failed to
make a prima facie case of obviousness. D’Arbelles ‘861 discloses the
desirability of using an ink-treated stamp to apply medically related
information to a patient’s body (FF 7, 8), and d’Arbelles ‘682 discloses that
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it is desirable to apply a marking designating the operative site at the
appropriate location on a patient’s body (FF 11, 12). Given these teachings,
we agree with the Examiner that a person of ordinary skill in the art would
have considered it obvious to use an ink-treated stamp to designate the
surgical operative site on a patient’s skin.
Regarding the limitation at issue, the use of a sterile stamp, we first
note that claims 19 and 20 do not recite this element (see App. Br. 12-13
(Claims Appendix)). We also note that Passmore’s disclosure relates to the
importance of sterility when applying skin-penetrating tattoo-type markers
(FF 9, 10), whereas the d’Arbelles references are directed to applying
markings to the surface of the patient’s skin.
However, d’Arbelles ‘682 discloses that when applying its temporary
tattoos to the skin, the skin should first be cleaned with alcohol, and then
sterile gauze and sterile water used to apply the tattoo to the skin, “to prevent
any untoward effects, i.e. infection” (d’Arbelles ‘682, col. 4, ll. 61-62 (FF
13)). Given this disclosure, we do not agree with Appellant that a person of
ordinary skill in the art would have reasoned that sterilizing a stamp for
applying medically related information to a patient’s skin would be
superfluous.
Rather, we agree with the Examiner that an ordinary artisan, being a
person of ordinary creativity and common sense, KSR, 550 U.S. at 421, and
being advised by d’Arbelles ‘682 and Passmore of the importance of sterility
when applying medically related information to a patient’s skin, would have
reasonably inferred that it would be desirable, when using ink-treated
stamps, to ensure the stamps’ sterility, particularly in when using the stamp
to indicate the operative site, as disclosed by d’Arbelles ‘682. Because this
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reasonable inference is based only on the disclosures of the references, we
do not agree that the Examiner applied improper hindsight in making the
conclusion of obviousness.
In sum, Appellant’s arguments do not persuade us that the Examiner
erred in concluding that a person of ordinary skill in the art would have
considered it obvious in view of the cited reference’s teachings to use sterile
stamps to place medical information of a patient’s skin. We therefore affirm
the Examiner’s obviousness rejection of claim 1.
Because they were not argued separately, claims 2-4, 7-10, and 13-20
fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
OBVIOUSNESS -- CLAIMS 5 and 11
Claims 5 and 11 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over d’Arbelles ‘861 in view of Passmore and d’Arbelles ‘682
as applied to claims 1 and 7, further in view of Gallub (Ans. 11).
Claim 5 recites “[t]he method of Claim 1, wherein the stamp includes
a schematic depiction.”
The Examiner reasons that a person of ordinary skill in the art would
have considered it obvious to modify the teachings of the d’Arbelles and
Passmore references “as taught by Gallub, to provide the stamping surface
with a design/symbol (schematic depiction) and marking the skin with the
stamp design/symbol (schematic depiction) in order to detect deep vein
thrombosis” (id.). Appellant does not present any specific arguments
regarding this ground of rejection (see App. Br. 4-10).
Because we detect no deficiency in the Examiner’s conclusion of
obviousness, we affirm the Examiner’s rejection of claim 5 as obvious over
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the d’Arbelles patents, Passmore and Gallub. Because it was not argued
separately, claim 11 falls with claim 5. See 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We reverse the Examiner’s rejection of claims 1-5, 7-11, and 13-20
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
However, we affirm the Examiner’s rejection of claims 1-4, 7-10, and
13-20 under 35 U.S.C. § 103(a) as being unpatentable over d’Arbelles ‘861
in view of Passmore and d’Arbelles ‘682.
We also affirm the Examiner’s rejection of claims 5 and 11 under 35
U.S.C. § 103(a) as being unpatentable over d’Arbelles ‘861, Passmore,
d’Arbelles ‘682, and Gallub.

TIME PERIOD
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

cdc
J. Michael Martinez de Andino
HUNTON & WILLIAMS
Riverfront Plaza, East Tower
951 East Byrd Street
Richmond VA 23219-4074
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