Ex Parte Gildenberg

Board of Patent Appeals and Interferences

Jan 28, 2011

12259456 (B.P.A.I. Jan. 28, 2011)

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
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/259,456 10/28/2008 Philip L. Gildenberg RR-GILD REI DIV 2 1038
41696 7590 01/28/2011
VISTA IP LAW GROUP LLP
12930 Saratoga Avenue
Suite D-2
Saratoga, CA 95070
EXAMINER
TRAN, KHOI H
ART UNIT PAPER NUMBER
3664
MAIL DATE DELIVERY MODE
01/28/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte PHILIP L. GILDENBERG
____________________

Appeal 2010-012415
Application 12/259,456
Technology Center 3600
____________________

Before: JENNIFER D. BAHR, LINDA E. HORNER, and FRED A.
SILVERBERG, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from the Examiner’s
decision rejecting claims 110-118 and 120-133 under 35 U.S.C. § 103(a) as
being unpatentable over Methods for Improving Outcomes in Surgical
Procedures, Robotic Surgery, Brown University 2008, available at
http://biomed.brown.edu/Courses/BI108/BI108_2008_Groups/group
12/Roboticsurgery.html (last visited Jun. 17, 2010) (Ex. A and D appended
to the Examiner’s Answer1) (hereinafter “Neuromate NPL”) and Appellant’s
Admitted Prior Art, at column 5, lines 23-34, and column 9, lines 55-60, of
Appellant’s Specification (hereinafter “AAPA”). The present application is
a divisional reissue application of U.S. Patent No. 7,130,717. The Examiner
has indicated that claims 134 and 135 are allowable, and has objected to
claim 119. Final Rej. 1, 5. No other claims are pending. We have
jurisdiction under 35 U.S.C. § 6(b).

THE INVENTION
The claims are directed to a method for hair transplantation which
utilizes a robot. Claim 110, reproduced below, is illustrative of the claimed
subject matter:2
110. A method of harvesting hair grafts using a robotic system,
comprising:

1 Exhibit D, of which Exhibit A is an excerpt, contains a more legible copy
of the Neuromate NPL description on which the Examiner relies.
2 Claim 120, which is the only other independent claim involved in this
appeal, is directed to a method of implanting hair grafts, comprising steps of
maneuvering a robot to position a hair follicle insertion device and operating
the hair follicle insertion device using a substantially automated process to
implant the hair graft.
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maneuvering a robot to position a tool carried by the
robot proximate a hair graft to be harvested; and
operating the tool using a substantially automated process
to harvest the hair graft.

SUMMARY OF DECISION
We REVERSE and enter a NEW GROUND OF REJECTION
pursuant to 37 C.F.R. § 41.50(b).

OPINION
A dispositive issue raised by Appellant in this appeal is whether the
combination of the documents describing the Neuromate NPL and the
AAPA relied upon by the Examiner renders obvious the method of
independent claims 110 and 120, in particular, including a step of
maneuvering a robot to position a tool carried by the robot proximate a hair
graft to be harvested (or proximate a location in which a hair graft is to be
implanted) and a step of operating the tool (or hair follicle insertion device)
“using a substantially automated process” to harvest (or implant) the hair
graft. App. Br. 16; Reply Br. 11-12.
Appellant’s Specification does not use the terminology “substantially
automated process,” much less explicitly define it. Appellant’s Specification
does, however, disclose that the movements of the robotic arm and the
operation of the hair follicle introducer “may be controlled by any suitable
computer software program.” Spec., col. 5, ll. 63-65. The Specification
further describes inclusion of a piston device or other operating mechanism
in the hair follicle insertion device 116, which could also be used as the plug
cutting device for removal of grafts directly from the patient’s scalp, to
permit the device to be operated by the robot. Spec, col. 6, ll. 25-31; col. 8,
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ll. 3-10; col. 10, ll. 1-4. Appellant’s Specification further describes
sequential actuation of the hair follicle insertion device by the robot, in order
to insert a plurality of hair follicles. Spec., col. 6, ll. 35-37. Additionally,
the Specification describes that the control of the robot is determined by the
stereotactic video system 300, and that the computer associated with the
robot and the stereotactic video system can distribute the grafts evenly on
the bald portion of the patient’s scalp in accordance with a plan. Spec., col.
8, ll. 46-64; col. 7, ll. 14-42 (discussing the stereotactic video system).
Further, according to the Specification, after the location of existing hair
follicles is determined and mapped by the system, the plug cutting/insertion
device could be operated and controlled by the robot to harvest the grafts
and to insert them. Spec., col. 9, ll. 43-46; col. 9, l. 61 to col. 10, l. 31.
In light of the findings above, we find that Appellant’s Specification
describes controlling the robot via the stereotactic video system 300 and a
computer associated with the robot, in accordance with a plan, to operate the
plug cutting/insertion device to harvest a hair graft and to implant a hair
graft. As such, consistent with Appellant’s Specification, we construe the
step of “operating the tool [hair follicle insertion device] using a
substantially automated process” as requiring automatically controlled
operation of the tool/insertion device by mechanical or electronic devices
that take the place of human labor.
We find that Neuromate NPL describes an “image guided, computer
controlled device [that] manipulates a 6 jointed robotic arm.” Neuromate
NPL (Ans., Ex. D, p. 10). Neuromate NPL also discloses, however, that
“[o]nce a plan is formed the surgeon will control the arm, using the imaging
displayed on a PC as to guide the operation.” Neuromate NPL (Ans., Ex. D,
p. 11). Moreover, paragraphs 4.0 and 5.0 of the “SUMMARY OF SAFETY
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AND EFFECTIVENESS” document submitted to the Food and Drug
Administration by Integrated Surgical Systems, Inc. in support of its notice
of intent to market the “Frameless NeuroMate Stereotactic System” describe
a computer-controlled, image-guided electromechanical multijointed arm for
stereotactic spatial positioning and orientation of an instrument holder or
tool guide “to be used by the surgeon to manually guide standard
neurosurgical instruments, under a surgeon-developed, carefully prepared
stereotactic treatment plan.” Ans., Ex. C (emphasis ours). In other words,
the descriptions of the Neuromate NPL relied upon by the Examiner indicate
that the surgeon will manually control the movement of the instrument to
perform the surgery, albeit using computer-control and image guidance
supplied by the Neuromate system.
Based on our findings above, the descriptions of the Neuromate
system provided by the documents (Ans., Ex. A, C, and D) relied upon by
the Examiner are insufficient to support the Examiner’s finding that
Neuromate NPL discloses a method comprising a step of operating a tool
using a substantially automated process to harvest or implant (Ans. 5, 8).
Further, these documents provide no teachings directed to positioning a tool
proximate a hair graft harvesting or implantation location or operating a tool
to harvest or implant the hair graft, much less performing such steps by
maneuvering a robot arm and operating the tool using a substantially
automated process, as called for in the claims.
The Examiner has not pointed to any portion of the AAPA as teaching
the steps of positioning a surgical tool proximate a hair graft harvesting or
implantation location and operating the tool to harvest or implant the hair
graft, much less as describing or suggesting the steps of maneuvering a robot
arm to position the surgical tool and operating the surgical tool using a
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substantially automated process (i.e., by mechanical or electronic devices
that take the place of human labor) to harvest or implant a hair follicle, so as
to make up for the deficiency in the Neuromate NPL documents relied upon
by the Examiner.
For the above reasons, we conclude that the Examiner has not
established that the combination of the documents describing the Neuromate
NPL (Ans., Ex. A, C, and D) and the AAPA relied upon by the Examiner
renders obvious the method of independent claims 110 and 120, in
particular, including a step of maneuvering a robot to position a tool carried
by the robot proximate a hair graft to be harvested (or proximate a location
in which a hair graft is to be implanted) and a step of operating the tool (or
hair follicle insertion device) “using a substantially automated process” to
harvest (or implant) the hair graft. Accordingly, we do not sustain the
rejection of claims 110 and 120, or of claims 111-118 and 121-133, which
depend from claims 110 and 120.

NEW GROUND OF REJECTION
Pursuant to our authority under 37 C.F.R. § 41.50(b), we make the
following new ground of rejection.
Claims 110 and 120 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combined teachings of the admitted prior art hair
transplantation process described in Appellant’s Specification (col. 1, l. 19 to
col. 2, l. 14); Bennett (US 5,439,475, iss. Aug. 8, 1995); and the prior art
Neuromate system approved for use by the FDA in 1999, as evidenced by
Exhibits A, C, and D appended to the Examiner’s Answer.
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The admitted prior art hair transplantation process
Hair transplantation is a widely-performed procedure. Spec., col. 1, ll.
19-20.
The admitted prior art hair transplantation process includes a graft
harvesting component in which surgeons remove an elliptically-shaped flap
of the patient’s scalp, and then use surgical tools (fine knives or scalpels) to
trim the flap into the desired number of micro and/or minigrafts. Spec., col.
1, ll. 43-54. We find that this trimming, or harvesting, step requires
positioning of the surgical tool proximate the hair graft, or hair grafts, to be
harvested, and operating the tool to trim, or harvest, the hair graft.
The admitted prior art hair transplantation process includes a graft
implantation component in which surgeons form slits, or openings, in the
patient’s scalp for receipt of the hair grafts, and then individually place each
hair graft, or plug, within one of the openings. Spec., col. 1, ll. 55-58.
In the admitted prior art hair transplantation process, or
“Megasession” procedure, a large number of grafts, usually 1000 to 2000
grafts, are implanted. Spec., col. 1, ll. 22-24. The procedure generally takes
a complete workday of from 5 to 8 hours to complete, and “is a long,
laborious, and tedious procedure.” Spec., col. 1, ll. 43-44, 62-64. The labor
intensive nature of the procedure, and the high level of training and skill of
the individuals performing the procedure, make the admitted prior art
procedure very expensive. Spec., col. 2, ll. 1-5. Accordingly, there has been
a recognized need in the art for a hair transplantation technique that is “less
long, laborious, tedious, and more economical, and which technique is less
labor intensive.” Spec., col. 2, ll. 11-14.
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Bennett
Bennett evidences that it was known in the art to perform the
implantation component of the hair transplantation process by loading pre-
prepared micrografts into a hair graft insertion tool, positioning the hair graft
insertion tool proximate the graft site, and operating the tool to implant the
micrografts. Col. 4, l. 38 to col. 5, l. 6.
Neuromate System
The Neuromate system gained FDA approval for use in neurosurgical
procedures in 1999. Ans., Ex. D, p. 10; Ans., Ex. C, paras. 3.0, 4.0, 5.0.
Further, Appellant acknowledges that the Neuromate robotic system is prior
art to Appellant’s claimed invention. Reply Br. 5.
The Neuromate system is a robotic system designed for neurosurgery,
and is an “image guided, computer controlled device that manipulates a 6
jointed robotic arm.” Ans., Ex. D, p. 10. The Neuromate robotic system
interacts with a known software system to provide a 3-dimensional view of
the anatomical structures involved in the surgery using appropriate imaging
systems. Id., p. 11. The Neuromate system guides the spatial positioning
and orientation of an instrument holder of the robot based on a preoperative
plan developed by the surgeon with 3-dimensional imaging software using
ultrasonic registration. Ans., Ex. C, paras. 3.0, 4.0. In the approved use of
the Neuromate system, the surgeon manually guides standard neurosurgical
instruments using the computer-controlled, image-guided robotic arm under
the surgeon-developed, carefully prepared surgical plan. Id.
Discussion
The harvesting component of the admitted prior art hair
transplantation process lacks a description of using a robotic system to
perform the harvesting and, in particular, lacks a description of maneuvering
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a robot to position a tool carried by the robot to the trimming position (i.e.,
proximate the hair graft to be harvested) and a description of operating the
tool using a substantially automated process to trim, or harvest, the hair
graft, as called for in claim 110.
While Appellant’s description of the admitted prior art process does
not explicitly refer to a hair follicle insertion device, we found above that
Bennett evidences that it was known in the art to perform the implantation
component of the hair transplantation process by loading pre-prepared
micrografts into a hair graft insertion tool, positioning the hair graft insertion
tool proximate the graft site, and operating the tool to implant the
micrografts. Accordingly, in view of the teachings of Bennett, it would have
been obvious to a person of ordinary skill in the art to perform the
implantation component of the admitted prior art hair transplantation process
by loading pre-prepared micrografts into a hair graft insertion tool,
positioning the hair graft insertion tool proximate the graft site, and
operating the tool to implant the micrografts. As modified in view of
Bennett, the implantation component of the admitted prior art hair
transplantation process lacks a description of using a robotic system to
perform the implanting and, in particular, lacks a description of maneuvering
a robot to position a hair follicle insertion device carried by the robot
proximate a graft implantation location and a description of operating the
insertion device using a substantially automated process to implant, as called
for in claim 120.
As we found above, however, the admitted prior art hair
transplantation process, or “Megasession,” typically involves the harvesting
and implantation of a large number of grafts, typically 1000 to 2000, and
was recognized as being long, tedious, labor intensive, and expensive.
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Reduction in the time and physical labor of long and labor intensive
processes is the classic and notorious reason for automation. Indeed, the
well established definition of “automation” is the use of self-operating
equipment or electronic devices “to replace human beings in doing routine
or repetitive work.” Webster's New World Dictionary 95 (David B. Guralnik
ed., 2nd Coll. Ed., Simon & Schuster, Inc. 1984). Given the admittedly art-
recognized repetitive, tedious, and labor intensive nature of the admitted
prior art “Megasession” hair transplantation process, and the recognized
desire in the art for a hair transplantation technique that is less long, labor
intensive, tedious, and costly, a person of ordinary skill in the art would have
been prompted to automate both the harvesting and implantation
components of the prior art process, both of which are repetitive, tedious,
and labor intensive, using known systems and devices.
The Neuromate system is a known system which uses a robotic
system interacting with a known software system using appropriate imaging
systems to assist a surgeon in developing a surgical plan and to guide the
spatial positioning and orientation of an instrument holder of the robot based
on that plan to aid the surgeon in manually guiding standard surgical
instruments using the computer-controlled, image-guided robotic arm.
Further, the Neuromate system is specifically adapted for surgery on a
patient’s head.
A person of ordinary skill in the art would have recognized that the
Neuromate system could be used to automate the admitted prior art hair
transplantation process by using a computer-controlled robotic arm to
manipulate the hair transplantation instruments to harvest and implant hair
grafts. Such automation of the hair transplantation process is nothing more
than the mere application of a known technique to a piece of prior art ready
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for the improvement. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417
(2007). Further, it would have been obvious to a person of ordinary skill in
the art to modify the Neuromate system or associated software and the
known harvesting and insertion tools, if necessary, to control the robot to
operate the hair graft harvesting and hair graft insertion tools using a
substantially automated process to replace the efforts of the surgeon in the
repetitive positioning and operation of the tools to perform the thousand or
more harvests or implantations. There is no evidence in the record before us
which would indicate that such modifications would have been beyond the
technical grasp of a person of ordinary skill in the art.
While the Neuromate NPL document cites as a disadvantage of the
system that it is “useful in neurosurgery only” (Ans., Ex. D, p. 12), we do
not find this to be a disincentive to the use of the Neuromate system in hair
transplantation. Rather, read in context, we find this remark to be a
recognition that, unlike more versatile surgical robots, such as the Da Vinci
robot, which can be used for a number of different applications on different
areas of the body, the Neuromate system is adapted specifically for surgery
on the head. We find nothing in the description of the Neuromate system
that suggests it could not be adapted for hair transplantation on a patient’s
head.
Further, as we found above, hair transplantation is a widely-performed
procedure, and thus would open up far greater usage potential for the
Neuromate system, as compared with neurosurgical applications only, for an
otherwise under-utilized and expensive system, thereby rendering the
Neuromate system more cost-effective and attractive for hospitals to
purchase. This potential would have prompted a person of ordinary skill in
the art to adapt and use the Neuromate system for hair transplantation.
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Appellant has argued that the teachings of prior art references such as
the Bennett and Bellantoni patents, discussed on pages 13 and 14 of the
Appeal Brief and page 10 of the Reply Brief, of desirably simple,
economical, hand-held and operated surgical hair transplantation tools
somehow teach away from the use of a robotic system in carrying out the
hair transplantation process. We find no inconsistency or conflict between
automation and a desire for simplicity and economy.
Appellant also argues that the idea of using a robot to perform a
cosmetic procedure such as hair transplantation would have been met with
great skepticism in the art. App. Br. 14. Appellant has provided no
evidence that this is the case. Appellant cites the value of human artistic
skills and judgment of the surgeon as an important factor for the success of a
hair transplantation procedure. Id. However, as we found above, the
Neuromate system permits the surgeon to develop a surgical plan using the
imaging system and software. Thus, the use of the Neuromate system
seemingly would not usurp the human artistic skills and judgment of the
surgeon.
Appellant argues that adaptation of the Neuromate system for use in
hair transplantation “would require a substantial reconstruction and complete
redesign of the Neuromate system,” citing imaging systems and surgical
tools as part of the redesign. App. Br. 18. Appellant has not alleged, much
less shown, that any redesign or modification required to adapt the
Neuromate system for hair transplantation would have been beyond the
technical grasp of a person of ordinary skill in the art. We do not agree with
Appellant that substitution of the surgical tools and imaging systems for
adapting the Neuromate system to be used for a hair transplantation would
“eliminate[e] its essential components and chang[e] its principles of
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operation,” so as not to make sense, as urged by Appellant. See id. As
discussed above, the reason for making such modifications or adaptations
would have been to reduce the long, tedious, and labor intensive nature of
the hair transplantation process, while offering increased utilization potential
for the Neuromate system, thereby making the system more attractive and
cost-effective for hospitals.
For the above reasons, we conclude that the combined teachings of the
admitted prior art hair transplantation process described in Appellant’s
Specification (col. 1, l. 19 to col. 2, l. 14); Bennett; and the prior art
Neuromate system approved for use by the FDA in 1999, as evidenced by
Exhibits A, C, and D appended to the Examiner’s Answer, would have
rendered obvious the subject matter of claims 110 and 120. No inference
should be drawn from the failure to make a new ground of rejection of other
claims.3 As the Board’s function is primarily one of review, we leave to the
Examiner to determine the patentability of the dependent claims in view of
the new ground of rejection and the prior art.

DECISION
The Examiner’s decision is reversed, and a new ground of rejection of
claims 110 and 120 is entered pursuant to 37 C.F.R. § 41.50(b).

3 See 37 C.F.R. § 41.50(b). See also Manual of Patent Examining Procedure
(MPEP), 8th ed., rev. 8, July 2010, § 1213.02. Under 37 C.F.R. § 41.50(b),
the Board may, in its decision, make a new rejection of one or more of any
of the claims pending in the case. Since the exercise of authority under
37 C.F.R. § 41.50(b) is discretionary, no inference should be drawn from the
decision to exercise that discretion with respect to some but not all of the
claims on appeal.
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FINALITY OF DECISION
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 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:
(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. . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

REVERSED; 37 C.F.R. § 41.50(b)

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