Ex Parte GildenbergDownload PDFBoard of Patent Appeals and InterferencesJan 28, 201112259456 (B.P.A.I. Jan. 28, 2011) Copy Citation 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. 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 Appeal 2010-012415 Application 12/259,456 2 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. Appeal 2010-012415 Application 12/259,456 3 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, Appeal 2010-012415 Application 12/259,456 4 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 Appeal 2010-012415 Application 12/259,456 5 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 Appeal 2010-012415 Application 12/259,456 6 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. Appeal 2010-012415 Application 12/259,456 7 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. Appeal 2010-012415 Application 12/259,456 8 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 Appeal 2010-012415 Application 12/259,456 9 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. Appeal 2010-012415 Application 12/259,456 10 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 Appeal 2010-012415 Application 12/259,456 11 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. Appeal 2010-012415 Application 12/259,456 12 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 Appeal 2010-012415 Application 12/259,456 13 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. Appeal 2010-012415 Application 12/259,456 14 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) mls VISTA IP LAW GROUP LLP 12930 SARATOGA AVENUE SUITE D-2 SARATOGA, CA 95070 Copy with citationCopy as parenthetical citation