Ex Parte AhmedDownload PDFBoard of Patent Appeals and InterferencesApr 13, 201211925418 (B.P.A.I. Apr. 13, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/925,418 10/26/2007 A. Mateen Ahmed 9299a 2948 21905 7590 04/16/2012 CONNORS ASSOCIATESpc 13421 Danbury Lane #135i SEAL BEACH, CA 90740 EXAMINER TREYGER, ILYA Y ART UNIT PAPER NUMBER 3761 MAIL DATE DELIVERY MODE 04/16/2012 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 A. MATEEN AHMED __________ Appeal 2011-000676 Application 11/925,418 Technology Center 3700 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a system for relieving fluid pressure from a body cavity. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2011-000676 Application 11/925,418 2 Statement of the Case Background “[T]his invention comprises a portable system for relieving fluid pressure from a body cavity of a patient. It includes a drainage catheter for insertion into the body cavity” (Spec. 2, l. 29 to 3, l. 2). The Claims Claims 58-71 are on appeal. Claims 58 and 61 are representative and read as follows: 58. A system for relieving fluid pressure from a body cavity of a patient comprising a drainage catheter for insertion into the body cavity, said catheter having an outlet end and an inlet end including at least one drainage aperture, said inlet end adapted to be inserted into the cavity at a predetermined position within the cavity with said outlet end extending from the body cavity, a one-way pressure-responsive valve that opens when the differential between atmospheric pressure and the pressure within the body cavity exceeds a predetermined difference and closes when said differential is less than said predetermined difference, said valve having an outlet and an inlet in fluid communication with the outlet end of the drainage catheter to permit pressure-regulated flow of fluid from the body cavity through the catheter, said outlet of the pressure-responsive valve being at substantially atmospheric pressure and the inlet of the pressure- responsive valve being at the pressure within the body cavity, a reservoir having an inlet in fluid communication with the outlet of the pressure-responsive valve so as to receive the fluid that passes therethrough, and a mounting member adapted to be detachably coupled to the patient nearby the body cavity, Appeal 2011-000676 Application 11/925,418 3 said drainage catheter, pressure-responsive valve, and reservoir being configured to be attached to the mounting member in predetermined fixed positions relative to each other where the inlet end of the drainage catheter, the inlet and outlet of the pressure-responsive valve, and the inlet of the reservoir all lie in substantially the same plane so essentially no hydrostatic pressure affects the flow of fluid from the cavity of the patient even with changing positions of the patient. 61. The system of Claim 58 where the body cavity is within the cranium and the mounting member comprises a headband adapted to be wrapped around the head of the patient. The issues A. The Examiner rejected claims 58 and 71 under 35 U.S.C. § 102(b) as anticipated by Krueger1 (Ans. 3-6). B. The Examiner rejected claim 60 under 35 U.S.C. § 103(a) as obvious over Krueger (Ans. 6-7). C. The Examiner rejected claim 59 under 35 U.S.C. § 103(a) as obvious over Krueger and Kirsch2 (Ans. 7-8). D. The Examiner rejected claims 61-70 under 35 U.S.C. § 103(a) as obvious over Krueger and Bunegin3 (Ans. 8-12). 1 Krueger et al., US 5,772,625, issued Jun. 30, 1998. 2 Kirsch et al., US 5,385,541, issued Jan. 31, 1995. 3 Bunegin et al., US 4,995,401, issued Feb. 26, 1991. Appeal 2011-000676 Application 11/925,418 4 A. 35 U.S.C. § 102(b) over Krueger The Examiner finds that “Krueger discloses an external drainage assembly 10 (Fig. 1) for a surgical patient that is able to mount to an IV pole, making it portable” (Ans. 3). The Examiner finds that the “drainage assembly 10 (Fig. 1) comprises a catheter 11 (Fig. 1) inserted into the head or cranium 12 (Fig. 1) of the patient. The catheter is connected to a stopcock valve 15 (Fig. 1), tubing lines 20, 23 (Fig. 1), and a pressure-activated one- way valve 24” (Ans. 3-4). The Examiner finds that “[d]ownstream of the valve 24 (Fig. 1), tubing 25 (Fig. 1) leads to burette or reservoir 55 (Fig.1) for collection of fluid from the patient. The entire assembly is attached to an IV pole 31 (Fig. 30) via mounting strap or member 98” (Ans. 4). The Examiner finds that the “drainage apparatus is placed in a position relative to the patient’s head such that the apparatus is leveled with the patient’s Foramen of Monro” (Ans. 4). The Examiner finds that the “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations” (Ans. 4). Appellant contends that the “structure called for in Claims 58 and 71 is absent in Krueger et al. Krueger has moveable components that required adjustment relative to each other each time the patient moves. The components of Krueger are not in fixed positions” (App. Br. 16). Appellant contends that “Krueger has a drain bag 81 that is not ‘nearby the body cavity.’ Their bag is not adapted to be coupled to the body of the patient as is Applicant’s structure” (App. Br. 16). Appeal 2011-000676 Application 11/925,418 5 Appellant contends that “this specific ‘predetermined fixed position’ of a mounted reservoir bag, allowing for a patient to change positions regardless of the reservoir bag’s position, was either overlooked or factually misinterpreted by the Examiner” (App. Br. 17-18). Appellant contends that “the manner of operating the apparatus differentiates claim 58 from the prior art” (App. Br. 22). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Krueger anticipates claims 58 and 71? Findings of Fact 1. Figure 1 of Krueger is reproduced below: “FIG. 1 is an elevational view of the external ventricle drainage assembly attached to a patient” (Krueger, col. 2, ll. 36-37). Appeal 2011-000676 Application 11/925,418 6 2. Krueger teaches “an external drainage assembly 10 for a surgical patient including tubing 11 which is attached to a suitable catheter in the form of a ventricle drain, the catheter being attached to the head 12 of the patient by a suture tab 13 to prevent relative movement between the catheter and patient” (Krueger, col. 3, ll. 62-67). 3. Krueger teaches that beyond the exit of the catheter from the patient’s scalp is a four-way patient line stopcock 15 . . . which provides a catheter port 16, an ICP support panel and upper portion of the drainage bag showing monitoring port 17 and a Y- connector port 19 controlled by a handle 18. This valve is followed by a length of tubing 20 terminating in a Y- connector, needle-less valve assembly 21 having a sampling site 22. (Krueger, col. 4, ll. 8-14). 4. Krueger teaches that “[t]ubing 23 downstream of the valve assembly contains a low-pressure, one-way valve 24 to help prevent reflux of fluid into the ventricles or lumbar subarachnoid space” (Krueger, col. 4, ll. 14-17). 5. Krueger teaches “a collection burette 55 mounted on a support panel 27 for collection and measurement of the fluid collected from the patient” (Krueger, col. 4, ll. 19-21). 6. Krueger teaches “a level/tape measuring device 105 utilized by a surgical nurse or other technician to determine the positioning of the support panel 27 relative to the patient during surgery” (Krueger, col. 6, ll. 4-8). Appeal 2011-000676 Application 11/925,418 7 7. Figure 5 of Krueger is reproduced below: “FIG. 5 is a cross sectional view . . . showing the panel attached to the IV pole” (Krueger, col. 2, ll. 45-46). 8. Krueger teaches that: The support panel 27 is suspended from the IV pole 31 via the suspension cord 29 and the drainage system height is positioned via the cord lock 30. If the panel is directly connected to the IV pole 31, the pole mount clamps 33 on the back of the support panel 27 are pushed onto the IV pole and secured in place by the “Velcro” connection of straps 35 . . . The straps should be securely tightened or the support panel may slip. (Krueger, col. 6, ll. 22-29). 9. Krueger teaches to “ensure that the system has been properly mounted and leveled with the zero point of the reference scale 42 aligned to the patient’s Foramen of Monro” (Krueger, col. 6, ll. 32-35). Principles of Law It is well settled that during examination, the PTO must interpret terms in a claim using “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in Appeal 2011-000676 Application 11/925,418 8 the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “A single prior art reference that discloses, either expressly or inherently, each limitation of a claim invalidates that claim by anticipation.” Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005). Analysis Claim interpretation Claim interpretation is at the heart of patent examination because before a claim is properly interpreted, its scope cannot be compared to the prior art. In this case, the limitation in claim 58 at issue is the requirement that the system components are “configured to be attached to the mounting member in predetermined fixed positions relative to each other” (Claim 58). During prosecution, claim terms are given their broadest reasonable interpretation as they would be understood by persons of ordinary skill in the art in the light of the Specification. Therefore, we first turn to the Specification to determine whether the phrase “predetermined fixed position” has any specified definition. The Specification teaches, regarding the Krueger device, that “the height of the fluid column 30 regulates the pressure differential through the drainage catheter 22” (Spec. 11, ll. 15-17). The Specification further teaches that for the Krueger device, “a nurse or attendant must move the column each time the patient wishes to move for example for a seated to a lying Appeal 2011-000676 Application 11/925,418 9 posture or vice versa” (Spec. 11, ll. 24-26). The Specification provides no specific definition of “predetermined fixed position”. In light of the Specification, the “predetermined fixed position” requirement of claim 58 is reasonably interpreted as simply requiring the components to be in fixed position relative to one another for some period of time. No particular structures or forms of fixation and no particular amounts of time are required by the phrase. See In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989) (“[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.”) Anticipation Krueger teaches a drainage catheter with outlet and inlet ends (FF 1-3) connected to a one-way pressure-responsive valve which permits pressure- regulated flow of fluid from the body cavity through the catheter (FF 4). Krueger teaches a reservoir in fluid communication with the valve (FF 5) connected to a mounting member that is coupled to the patient (FF 1, 7, 8). Krueger teaches that the drainage catheter, pressure-responsive valve and reservoir are attached to the mounting member in a particular position relative to the patient (FF 1, 8) where “the system has been properly mounted and leveled with the zero point of the reference scale 42 aligned to the patient’s Foramen of Monro” (Krueger, col. 6, ll. 32-35; FF 11). Appellant contends that the “structure called for in Claims 58 and 71 is absent in Krueger et al . Krueger has moveable components that required adjustment relative to each other each time the patient moves. The components of Krueger are not in fixed positions” (App. Br. 16). Appellant Appeal 2011-000676 Application 11/925,418 10 contends that “Krueger has a drain bag 81 that is not ‘nearby the body cavity.’ Their bag is not adapted to be coupled to the body of the patient as is Applicant’s structure” (App. Br. 16). We are not persuaded. There is no requirement in claim 58 that the components are not moveable. Appellant does not identify a teaching in Krueger that the components necessarily require adjustment for every movement of the patient. Further, the components of Krueger are in fixed positions when attached to the mounting member. As Krueger teaches “[i]f the panel is directly connected to the IV pole 31, the pole mount clamps 33 on the back of the support panel 27 are pushed onto the IV pole and secured in place by the ‘Velcro’connection of straps 35” (Krueger, col. 6, ll. 22-29; FF 8). The use of the phrase “secured in place” and “securely tightened” clarifies that these components are reasonably interpreted as being in a fixed position. Appellant contends that “this specific ‘predetermined fixed position’ of a mounted reservoir bag, allowing for a patient to change positions regardless of the reservoir bag’s position, was either overlooked or factually misinterpreted by the Examiner” (App. Br. 17-18). Appellant contends that “the manner of operating the apparatus differentiates claim 58 from the prior art” (App. Br. 22). We are not persuaded. Appellant’s argument that the “manner of operating the apparatus differentiates claim 58 from the prior art” highlights the flaw in the argument. It must be the structure and not simply the mode of operation or intended use which differentiates a product claim. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (“It is well settled that the Appeal 2011-000676 Application 11/925,418 11 recitation of a new intended use for an old product does not make a claim to that old product patentable.”) In addition, if the patient is not allowed to change positions, as Appellant implicitly asserts, then the apparatus necessarily remains in a predetermined fixed position relative to the unmoving patient, as well. Appellant also relies on the Ahmed Declaration4 to overcome the anticipation rejection. The Ahmed Declaration contends that “a nurse need not constantly monitor the patient and does not need to make any adjustments if the patient moves” (Ahmed Dec. 4 ¶ 5). The Ahmed Declaration contends that “it is the bag position AND the preset open/close pressure setting of the valve 24 and not solely the valve that controls the opening and closing of the valve 24” (Ahmed Dec 5 ¶ 6). We are not persuaded. These represent functional limitations on how the system is used and not structural limitations in the claims. There is no requirement in either claim 58 or 71 that either a nurse not monitor a patient and adjust the device or that the pressure setting of the valve solely controls the opening and closing of the valve. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Conclusion of Law The evidence of record supports the Examiner’s conclusion that Krueger anticipates claims 58 and 71. 4 Declaration of A. Mateen Ahmed, filed Mar. 8, 2010. Appeal 2011-000676 Application 11/925,418 12 B. and C. 35 U.S.C. § 103(a) over Krueger or over Krueger and Kirsch The Examiner finds that “Krueger discloses the invention discussed above, but does not expressly disclose the particular parameter of the distance range between the outlet of the valve and the inlet of the reservoir” (Ans. 6). The Examiner finds it obvious “to make the distance range between the outlet of the valve and the inlet of the reservoir depending of the portability grade required, since discovering the optimum or workable ranges involves only routine skill in the art” (Ans. 7). The Examiner also finds it obvious to “use the slit valve disclosed by Kirsch as the pressure valve disclosed by Krueger for providing pressure-controlled treatment of hydrocephalus” (Ans. 8). Appellant contends that “combining Krueger and Kirsch et al is irrelevant. It is not the type of control valve that is important. It is the fixed positions of the components as called for in system of Claims 58 through 71 that is important to eliminate the effects of gravity” (App. Br. 22). We find that the Examiner has the better position. Having already found that Krueger anticipates claim 58, we agree with the Examiner that selecting the optimum distance between the outlet of the valve and inlet of the reservoir represents routine optimization. See In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”) We also agree that it would have been obvious to substitute the equivalent valve of Kirsch for the valve of Krueger. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“If a person of Appeal 2011-000676 Application 11/925,418 13 ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”) D. 35 U.S.C. § 103(a) over Krueger and Bunegin The Examiner finds that “Krueger discloses the claimed invention discussed above, but does not expressly disclose the mounting member comprising a headband” (Ans. 8). The Examiner finds that “Bunegin discloses a device for measuring intracranial pressure, which, like a cerebrospinal shunt system, must be mounted on a patient’s head. Bunegin's pressure monitor system is affixed to a harness” (Ans. 8). The Examiner finds it obvious to “use a headband and head-mounting system as disclosed by Bunegin to replace or augment the adjustable mounting strap disclosed by Krueger in order to maintain the position of a cranium-based medical device level with (as disclosed by Krueger) and on the patient’s head, as taught by Bunegin” (Ans. 9). Appellant contends that “[n]either Krueger nor Bunegin recognize, or in any way suggest, that a fixed structural relationship between the various inlets and outlets within the system is of any consequence” (App. Br. 33). Appellant contends that “neither Krueger nor Bunegin discuss that changes in the internal hydrostatic pressure of the system might endanger a patient” (App. Br. 33). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Krueger and Bunegin render claims 61 to 70 obvious? Appeal 2011-000676 Application 11/925,418 14 Findings of Fact 10. Bunegin teaches “a device suitable for use in an anterior fontanelle pressure sensing system. This device allows one to make rapid and accurate measurements of the anterior fontanelle pressure of an infant using a noninvasive technique” (Bunegin, col. 1, ll. 7-11). 11. Bunegin teaches that in a “preferred embodiment, the device is affixed to the cranium with harness 41. Preferably, the harness has a central device retaining ring 42 made of a flexible plastic material and adjustable elastic straps 43 attachable to an adjustable VELCRO ® headband 44 which can be tightened or loosened to accommodate the size of the cranium of any particular infant” (Bunegin, col. 7, ll. 30-36). 12. Figure 5 of Bunegin is reproduced below: “FIG. 5-illustrates an assembled anterior fontanelle monitor (AFM) monitoring system and also illustrates a preferred manner of attaching the device to the cranium” (Bunegin, col. 5, ll. 20-23). Appeal 2011-000676 Application 11/925,418 15 Principles of Law “Rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis While we conclude that the Examiner correctly finds that Krueger anticipates claim 58, and we agree that Bunegin teaches mounting a device for measuring intracranial pressure on a patient’s head (FF 10-12), we are not persuaded that it would have been obvious to modify Krueger’s device to use the head mounting system of Bunegin. The head mounting system of Bunegin is entirely focused on measuring pressure in the fontanelle (FF 8). There is no connection between Bunegin and the drainage system of Krueger. There is also no teaching or suggestion in Krueger that the drainage support panel could be directly attached to a patient’s head, but rather Krueger teaches that the support panel is suspended from an IV pole using straps which may be securely tightened (FF 8). We find that the Examiner’s reason to combine, to “maintain the position of a cranium-based medical device level with (as disclosed by Krueger) and on the patient’s head, as taught by Bunegin” (Ans. 9) represents impermissible hindsight. We are not persuaded that an ordinary artisan, considering Krueger and Bunegin while inventing, would have reasonably considered incorporating the headband of Bunegin to hold the drainage catheter assembly of Krueger in place, since the prior art did not Appeal 2011-000676 Application 11/925,418 16 recognize the idea of placing the complete drainage assembly onto the patient’s head. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Krueger and Bunegin render claims 61 to 70 obvious. SUMMARY In summary, we affirm the rejection of claims 58 and 71 under 35 U.S.C. § 102(b) as anticipated by Krueger. We affirm the rejection of claim 60 under 35 U.S.C. § 103(a) as obvious over Krueger. We affirm the rejection of claim 59 under 35 U.S.C. § 103(a) as obvious over Krueger and Kirsch. We reverse the rejection of claims 61-70 under 35 U.S.C. § 103(a) as obvious over Krueger and Bunegin. 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-IN-PART dm Copy with citationCopy as parenthetical citation