Ex Parte RadojicicDownload PDFPatent Trial and Appeal BoardMar 17, 201712228697 (P.T.A.B. Mar. 17, 2017) 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. MR-1003 6931 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3763 MAIL DATE DELIVERY MODE 12/228,697 08/16/2008 759036088 KANG LIM 3494 Camino Tassajara #444 Danville, CA 94506 Milan Radojicic 03/17/2017 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MILAN RADOJICIC Appeal 2015-006074 Application 12/228,697 Technology Center 3700 Before MICHAEL L. HOELTER, LYNNE H. BROWNE, and BRENT M. DOUGAL, Administrative Patent Judges. BROWNE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Milan Radojicic (Appellant) appeals under 35 U.S.C. § 134 from the rejection of claims 1—3, 5—9, 11—14, 16—22, 32, and 34. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2015-006074 Application 12/228,697 CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A spinal catheter comprising: an elongate shaft having a distal end and a proximal end, wherein the distal end is adapted for placement in a spinal fluid pathway, epidural space, ventricle or cistern; monitoring lumen connected to a monitoring port at a distal end, wherein the monitoring port is a first port housing a transducer, wherein the transducer determines pressure data in the spinal fluid pathway, epidural space, ventricle or cistern; an inlet lumen formed on the elongate shaft and connected to an inlet port, wherein the inlet port is a second port; an outlet lumen connected to an outlet port, wherein the outlet port is a third port, wherein at least one of the inlet port and the outlet port supplies infuses or exchanges fluid to establish changes in volume; and an I/O system configured to receive the pressure data and generate impedance measurements based upon the relationship between the changes in volume and the pressure data. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Cioanta US 2002/0082556 A1 June 27, 2002 Purdy US 2003/0097082 A1 May 22, 2003 Kucharczyk US 6,626,902 B1 Sept. 30, 2003 Scarborough US 2004/0193045 A1 Sept. 30, 2004 Reich US 2005/0020962 A1 Jan. 27, 2005 Neff US 2005/0171452 A1 Aug. 4, 2005 2 Appeal 2015-006074 Application 12/228,697 REJECTIONS1 I. Claims 1—3, 5—9, 11—14, 16—22, 32, and 34 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. II. Claims 1—3, 5—9, 11—14, 16—22, 32, and 34 stand rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. III. Claims 1, 3, 5—9, 11—14, 16, 17, 19-22, and 32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Purdy, Kucharczyk, and Scarborough. IV. Claim 2 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Purdy, Kucharczyk, Scarborough, and Cioanta. V. Claim 18 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Purdy, Kucharczyk, Scarborough, Neff, and Reich. VI. Claim 34 stands rejected 35 U.S.C. § 103(a) as unpatentable over Purdy, Kucharczyk, Scarborough, and Reich. DISCUSSION Rejection I The Examiner determines that there is no support in the Specification, as filed, for “the limitation ‘an I/O system configured to receive the pressure data and generate impedance measurements based upon the relationship 1 We do not consider the Examiner’s Specification objection as these issues pertain to petitionable, not appealable matters and are not within the jurisdiction of the Board. See MPEP §§ 1002 and 1201. 3 Appeal 2015-006074 Application 12/228,697 between the changes in volume and the pressure data’” as required by claim 1. Final Act. 3^4 (emphasis omitted). The Examiner explains that: inclusion of the priority document provides the following recitation directed towards “compliance/impedance measurements”: “Ports would allow for sampling, removal and exchange of spinal fluid thereby allowing infusion studies to establish a pressure/volume relationship of the spinal compartment and compliance/impedance measurements of the spinal cord in injury and disease . . . “ [formatting altered for emphasis]. Looking at this recitation the specification appears to suggest that “pressure/volume relationships” and “compliance/impedance measurements” are two separate and distinct functions (note the use of the “and” conjunction separating the two clauses. In any case, there is no support for generating “impedance measurements based upon the relationship between the changes in volume and the pressure data”. The specification makes no correlation between the two functions and therefore cannot be relied upon for the claim limitations. Id. at 4 (emphasis omitted). Appellant contends that “compliance and impedance measurements, if actually measured rather than merely modeled, require the usage of the relationship between volume and pressure.” Appeal Br. 16. In support of this contention, Appellant proffers Marmarou (A Nonlinear Analysis of the Cerebrospinal Fluid System and Intracranial Pressure Dynamics, Anthony Marmarou et al., J. Neurosurg., Vol. 48, March 1978, pp. 332—344) and Aygok (Cerebrospinal Fluid Infusion studies: Current View and Concepts in Assessment of Post-Traumatic Hydrocephalus, Gunes A. Aygok et al, Inf 1 Neurotrauma Letter, Issue 22, International Brain Injury Assoc., 2010 pp. 1— 3) noting that: the Marmarou reference explicitly states, at page 333, that “The amount of pressure rise will depend upon the intracranial compliance. By definition, the ratio of change in volume to 4 Appeal 2015-006074 Application 12/228,697 change in pressure dV/dP equals the compliance (C) which can be obtained by measuring the slope of a volume-pressure curve of the system under study.” Id. (emphasis omitted). Appellant further notes that: Marmarou continues by stating that “The rate of outflow (I~) is given by the gradient of pressure between CSF space and the venous system of the dural sinus (Pd) divided by the resistance to absorption (R).” Thus, the rate of outflow (volume change) is dependent upon pressure gradient and resistance to absorption. The term ‘impedance’ in this field, is simply another word for ‘resistance to absorption’. This is confirmed in Marmarou at page 342 which states “removal of CSF at a rate equal to formation negates the contribution of the CSF impedance (R) to the level of ICP.” Id. (citations and emphasis omitted). “[T]he test for [written description] sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Here, the fact that the Appellant had possession of an I/O system configured to receive the pressure data and generate impedance measurements is not contested. Rather, the question is whether or not Appellant had possession of a system that generates impedance measurements based on the relationship between the changes in volume and the pressure data. See Non-Final Act. 4. Appellant proffers evidence that one skilled in the art would understand that the impedance measurements are based upon the relationship between the changes in volume and the pressure data. Appeal Br. 16 (citing Marmarou). The Examiner does not contest this evidence, rather the Examiner submits that the impedance measurements could be obtained in a different manner. See Ans. 5. However, the fact that impedance measurements could be obtained in a different manner does not 5 Appeal 2015-006074 Application 12/228,697 mean that those skilled in the art would understand the measurements to be obtained in that manner. Rather, as evidenced by Marmarou, one skilled in the art would understand the impedance measurements to be obtained based upon the relationship between the changes in volume and the pressure data. For this reason, we do not sustain the Examiner’s decision rejecting claim 1, and claims 2, 3, 5—9, 11—14, 16—22, 32, and 34, which depend therefrom, as failing to comply with the written description requirement. Rejection II The Examiner states that: Regarding Claims 1, 18, and 34, Applicant makes reference towards “impedance measurements” and “compliance measurements”, appearing to indicate that they are two different functions. However, Applicant’s only recitation only introduces impedance in brief disclosure as "compliance/impedance measurements". It is therefore not clear how Applicant is attempting to use the term “impedance”, whether this is a measurement separate and distinct from physiological “compliance”, a synonym for “compliance”, or an analog of “compliance”. Final Act. 6. However, claim 1 does not recite “compliance” and the recitation of “cerebrospinal compliance” in claim 18 and “compliance measurements” in claim 34 are clearly recitations of separate limitations than the recitation of “impedance measurements” in claim 1. See Appeal Br. 30,32,35. It appears that the Examiner is reading Appellant’s arguments pertaining to “compliance/impedance measurements” into the claims in order to create confusion where none exists. See e.g. Response to Non-Final Action filed January 9, 2014, p. 15; Appeal Br. 15. Appellant contends that the terms “compliance” and “impedance” are being used in accordance with their ordinary and customary meaning. See Appeal Br. 20. We agree. 6 Appeal 2015-006074 Application 12/228,697 We do not sustain the Examiner’s decision rejecting claims 1,18, and 34 as being indefinite. Rejections III, IV, and V Claims 1-3. 5. 7-9. 11-14. 16. 17. 19-22. and 32 Appellant argues claims 1—3, 5, 7—9, 11—14, 16, 17, 19-22, and 32 together.2 Appeal Br. 27. We select independent claim 1 as the representative claim, and claims 2, 3, 5, 7—9, 11—14, 16, 17, 19—22, and 32 stand or fall with claim 1. The Examiner finds that Purdy discloses all of the limitations of claim 1 except for “a single catheter having the at least three ports” and a system including “an I/O system configured to receive the pressure data and generate impedance measurements based upon the relationship between the changes in volume and pressure data.” Final Act. 8, 9. The Examiner further finds that Kucharczyk discloses a catheter including a plurality of ports (6, 8, 10, 12, 14, and 16) . . . that . . . may include monitoring ports (16, 68, 82) which carrying monitoring transducers (34, 84, 70) which may be configured to monitor pressure data (Col. 13, Ln. 3-42). Kucharczyk discloses that these ports may also include inlet and outlet ports for removing or delivering fluids (64 and 74; Col. 12, Ln. 56 - Col. 13, Ln. 2). and that “Scarborough discloses a spinal fluid introduction system (Abstract) . . . that. . . may be configured to include an I/O system (24) that is configured to receive pressure and volume data and generate impedance measurements based thereupon (Par. 22, Par. 75, Par. 76, and Clm. 17).” Id. 2 Claims 2 and 18 are subject to a different ground of rejection than claim 1; however, Appellant groups claims 2 and 18 with claim 1 and do not present arguments pertaining to the separate grounds of rejection (i.e. arguments pertaining to Rejections III and IV). Accordingly, we understand Appellant to rely on the same arguments for Rejections III and IV as discussed infra with respect to Rejection I, and also group claims 2 and 18 with claim 1. 7 Appeal 2015-006074 Application 12/228,697 Based on these findings, the Examiner determines that it would have been obvious “to configure the catheter of Purdy to include at least three lumens terminating in at least three ports, as disclosed by Kucharczyk, in order to supply a unitary, combined catheter that can perform all the specified infusion, aspiration, sampling, and monitoring functions” and “to configure the system of Purdy to include an I/O system configured to measure pressure and volume data to determine the impedance measurement, as disclosed by Scarborough, in order to control the amount of fluid transferred while controlling the physiological parameters of the fluid space.” Id. at 9. Although he acknowledges that “Purdy is capable of measuring pressure data,” Appellant contends that Purdy “also teaches away from the monitoring of compliance and/or impedance measures.” Appeal Br. 21. In support of this contention, Appellant argues that “Purdy contemplates a catheter system which operates in what is considered a ‘static’ cerebral spinal fluid environment.” Id. at 21—22. However, even assuming that Appellant is correct that Purdy is concerned with a “static” cerebral spinal fluid environment, such teachings do not constitute a teaching away from the proposed combination. As noted by the Examiner (Ans. 8—9), “teaching away” requires that the reference “criticize, discredit, or otherwise discourage” the use of other alternatives. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). We will not read into a reference a teaching away from a proposed combination when no such language exists. See Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006). Appellant further argues that Purdy and Scarborough are uncombinable because “[t]he entire purpose of Scarborough is to generate a distended organ, which would be fatal in the setting of the cerebrospinal 8 Appeal 2015-006074 Application 12/228,697 system.” Appeal Br. 22. However, this argument is not responsive to the rejection as articulated by the Examiner. As discussed supra, the rejection does not rely on Scarborough’s teachings pertaining to pressure and volume. Rather, Scarborough is merely relied upon to show that the use of I/O systems for generating impedance measurements was known in the art. See Final Act. 9. Appellant does not contest the Examiner’s findings or explain why Scarborough’s teaching of an I/O system is not applicable to Purdy’s device. Thus, Appellant fails to apprise us of error. Then, Appellant argues that “Purdy doesn’t contemplate the determination of compliance or impedance measurements.” Appeal Br. 23. Appellant is correct; however, this is not indicative of error, because Purdy is not relied upon to teach the limitations pertaining to impedance measurements. Rather, as discussed supra, Scarborough is relied upon to meet these limitations. Further, we note that compliance measurements are not claimed. See id. at 30. Moreover, nonobviousness cannot be established by attacking the references individually when the rejection is predicated upon a combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). In addition, Appellant contends that Scarborough is non-analogous art. See Appeal Br. 24. In support of this contention, Appellant argues that “[wjhile the general location of these medical devices [, i.e. Purdy and Scarborough] are close, they are extremely different in application, result and intended purpose” and that “the problems being addressed by these two disclosures are entirely different: one being diagnosis of spine disc degeneration and the other being issues with the cerebral-spinal fluid pathway.” Id. 9 Appeal 2015-006074 Application 12/228,697 Appellant compares Scarborough to Purdy (id.); however, this is not the correct inquiry. “Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citing In re Deminski, 796 F.2d 436, 442 (Fed.Cir.1986); In re Wood, 599 F.2d 1032, 1036 (CCPA 1979)). The instant Specification describes the field of Appellant’s endeavor as relating “generally to surgical methods and medical devices. More particularly, it concerns methods and devices for monitoring and delivering therapeutics to the spinal cord and brain along a spinal fluid pathway or cistern, particularly the lumbar cistern.” Spec. 1. Scarborough “relates to a system and method for introducing fluid into a spine.” Scarborough 12. Thus, Scarborough is in the same field of endeavor as the instant invention. Furthermore, one of the problems with which Appellant is involved is monitoring of a pressure- volume relationship. See Spec. 2. As discussed supra, Scarborough discloses an I/O system for performing such monitoring. Thus, Scarborough is reasonably pertinent to a problem with which Appellant is involved. Accordingly, Scarborough qualifies as analogous art under both prongs of the test outlined in Bigio. Next, Appellant contends that “impedance and compliance are not analogous measurements, and Scarborough fails to even contemplate a compliance measurement.” Appeal Br. 25. In support of this contention, Appellant argues that: the impedance measurements of Scarborough are vastly different from those of the presently claimed invention in regards to 10 Appeal 2015-006074 Application 12/228,697 purpose, means of generating the value (pressure volume relationship taken internally versus knowing fluid viscosity, needle size etc. and computing impedance before the device is even inserted into the patient) and even what the impedance is measured for (device assembly versus body cavity). Id. However, none of these alleged differences between Scarborough’s impedance measurements and the impedance measurements discussed in the Specification are claimed. See id. at 30. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Moreover, as discussed supra, compliance measurement is not claimed. See id. Thus, Appellant does not apprise us of error. Finally, Appellant argues that “the combination of Purdy and Kucharczyk would be inoperable for the intended purpose [because] Kucharczyk fails to address larger volume infusion and only mentions micro-dialysis as it relates to a microscopic tissue sampling process.” Appeal Br. 26. Again, Appellant’s argument is not responsive to the rejection as articulated by the Examiner. As discussed supra, Kucharczyk is only relied upon to show that catheters with multiple lumens and multiple ports are known. Appellant does not contest the Examiner’s finding or explain why Kucharczyk’s teaching of multiple lumens and multiple ports could not be applied to Purdy’s device. Thus, Appellant doesn’t apprise of error. For these reasons, we sustain the Examiner’s decision rejecting claim 1, and claims 2, 3, 5, 7—9, 11—14, 16, 17, 19-22, and 32, which fall therewith. 11 Appeal 2015-006074 Application 12/228,697 Claim 6 Regarding claim 6, the Examiner determines that although Purdy fails to explicitly disclose that the pressure transducer monitors the “central canal size” and presence of “parenchymal edema”, Examiner submits that these measurements flow directly from the measurement of pressure, a function provided by the catheter of Purdy. Examiner submits that by measuring pressure continually, Purdy would detect changes in the central canal size, diameter of the vessel impacting pressure of the fluids therein, as well as parenchymal edema, characterized by an increase in pressure within the parenchymal space. Final Act. 10. Appellant contends that because “the cerebral spinal pathway is being modeled by Purdy as ‘static’, then even with continuous pressure measurements, the identification of ‘central canal size’ and presence of ‘parenchymal edema’ is entirely foreign to the disclosure of Purdy.” Appeal Br. 27—28. In support of this contention, Appellant argues that “[pressure data alone is not sufficient to ascertain the structure. For example, two people can have identical blood pressures, but one might be suffering from a thoracic aortic aneurysm. Only visualization with appropriate imaging . . . would yield the diagnosis.” Id. at 28 (emphasis omitted). Responding to this argument the “Examiner submits that changes in central canal size and parenchymal edema will inherently cause fluctuations in pressure and volume of the CSF.” Ans. 13. Based on this submission, the Examiner reasons that “Purdy is purposed to measure fluctuations in general, ergo Purdy is purposed to detect changes in pressure/volume resultant from changes in the canal size and instances of edema.” Id. However, the Examiner makes no findings in support of this submission, and the Examiner’s reasoning is speculative at best. 12 Appeal 2015-006074 Application 12/228,697 Accordingly, we do not sustain the Examiner’s decision rejecting claim 6. Rejection V Claim 18 is subject to a different ground of rejection than claim 6; however, Appellant groups claim 18 with claim 6. Appeal Br. 27—28. Accordingly, we understand Appellant to rely on the same persuasive arguments discussed supra, in contesting the rejection of claim 18. Accordingly, we do not sustain the Examiner’s decision rejecting claim 18 for the same reason we do not sustain the Examiner’s decision rejecting claim 6. Rejection VI Appellant does not present arguments pertaining to the rejection of claim 34, the only claim rejected in Rejection VI. See generally, Appeal Br. Accordingly, we summarily sustain the Examiner’s decision rejecting claim 34. DECISION The Examiner’s rejections of claims 1—3, 5—9, 11—14, 16—22, 32, and 34 under 35 U.S.C. § 112 are REVERSED. The Examiner’s rejections of claims 1—3, 5, 7—9, 11—14, 16, 17, 19- 22, 32, and 34 under 35 U.S.C. § 103(a) are AFFIRMED. The Examiner’s rejections of claims 6 and 18 under 35 U.S.C. § 103(a) are REVERSED. 13 Appeal 2015-006074 Application 12/228,697 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART 14 Copy with citationCopy as parenthetical citation