Ex Parte OWEN et al

Patent Trials and Appeals BoardMar 18, 2019

13105726 - (D) (P.T.A.B. Mar. 18, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/105,726 05/11/2011 Richard Harley Grenville OWEN 22428 7590 03/20/2019 Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 093840-0103 3819 EXAMINER EISEMAN, ADAM JARED ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 03/20/2019 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RICHARD HARLEY GRENVILLE OWEN, STEPHEN BLATCHER, STEW ART MADDISON FOX, and MARTIN LAWRENCE HUGHES Appeal2017-006328 Application 13/105,726 Technology Center 3700 Before BENJAMIN D. M. WOOD, ANNETTE R. REIMERS, and SEAN P. O'HANLON, Administrative Patent Judges. O'HANLON, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Richard Harley Grenville Owen et al. ("Appellants") 1 appeal under 35 U.S.C. Â§ 134(a) from the Examiner's decision, as set forth in the Final Office Action dated March 23, 2016 ("Final Act."), rejecting claims 1-15 1 The Appeal Brief identifies PlaqueTec Limited as the real party-in-interest. Appeal Br. 2. Appeal2017-006328 Application 13/105,726 and 22 (all pending claims). Appellants' representative presented oral argument on March 7, 2019. We have jurisdiction over this appeal under 3 5 U.S.C. Â§ 6(b). We AFFIRM. SUMMARY OF THE INVENTION The claimed subject matter "relates to a catheter for insertion into a blood vessel allowing blood samples to be taken." Spec. 1. Claims 1, 5, 11, and 13 are independent. Claim 1, reproduced below from page 25 (Claims Appendix) of the Appeal Brief, is illustrative of the claimed subject matter: 1. A method for generating a data profile for one or more biomarkers at a site of interest in a blood vessel, comprising the steps of: analyzing a plurality of blood samples obtained from respective locations along a length of the blood vessel; measuring the concentration of the one or more biomarkers in each of the samples; generating a data profile of the concentration levels for the one or more biomarkers along the length of said blood vessel; and obtaining the plurality of blood samples having a volume between about 10Âµ1 and 50Âµ1 from the respective locations along the length of the blood vessel; wherein the step of obtaining the plurality of blood samples comprises obtaining the plurality of blood samples substantially simultaneous! y. REFERENCES The Examiner relies on the following prior art references in rejecting the claims on appeal: Wallace Brown US 2002/0026174 Al WO 2004/010874 Al 2 Feb.28,2002 Feb. 5,2004 Appeal2017-006328 Application 13/105,726 REJECTIONS I. Claims 1-15 and 22 stand rejected under 35 U.S.C. Â§ 112, second paragraph, as being indefinite. II. Claims 1-15 and 22 stand rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Brown and Wallace. ANALYSIS Rejection I The Examiner determines that "[t]he term 'about' in claims 1, 5, 11 and 13 and claims dependent therefrom, is a relative term which renders the claim indefinite." Final Act. 2. According to the Examiner, "[t]he [S]pecification does not give any definition to the term about, and as such it is unclear as to what margin of error or tolerance is applied to the claimed ranges, thus leaving the claims indefinite." Id. at 3; see also Ans. 8-10. Appellants traverse, arguing that "the term 'about' as recited in claims 1, 5, 11 and 13 should be afforded its plain and ordinary meaning of 'approximately"' and that "those of ordinary skill in the art would have known the approximate volume of a sample needed for a diagnostic chemistry process." Appeal Br. 7 (citing MPEP Â§ 2173.05(b)(III)). Appellants note that "[t]he term 'about' is routinely used in patent claims, and the courts routinely construe it as plain meaning [sic], accordingly to how 'a person having ordinary skill in the art' would understand it." Reply Br. 3. "[T]he word 'about' does not have a universal meaning in patent claims, and [its] meaning depends on the technological facts of the particular case." Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 3 Appeal2017-006328 Application 13/105,726 1995). Use of the word about as part of a numeric range avoids a strict numerical boundary to the specified parameter. Cohesive Techs. Inc. v. Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008). In determining the range encompassed by the term about, one must consider the context of the term as it is used in the specification and claims of the application. Pall, 66 F.3d at 1217. Here, the Specification discusses the sample volume as follows: "Many diagnostic chemistry processes require samples of approximatefv 50 Âµl and, hence, for many embodiments each discrete sample is substantially of this value. However, the discrete samp1es may be between 0.1 Âµ.l and 100 ÂµL more preferably between 20 Âµland 50 ~tL" Spec. 6 ( emphases added). 'Thus, the Specification supports A.ppe11ants' assertion that the term about as used in the claims means "approximately." See Appeal Br. 7; see also Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1369 (Fed. Cir. 2005) (recognizing the ordinary meaning of about to be approximately). The Examiner appears to apply a per se rule that because the claims include the word about, the claims are indefinite. Such an approach is improper, as it is well established that the use of relative terminology in claim language does not automatically render the claim indefinite. See, e.g., Seattle Box Co., Inc. v. Indus. Crating & Packaging, Inc., 731 F .2d 818, 826 (Fed. Cir. 1984). Rather, the correct test is whether one of ordinary skill in the art would understand what is claimed when the claim is read in light of the specification. Id. As set forth above, one of skill in the art would understand that "a volume between about 1 OÂµl and 50~11'' means a volume between approximately 10 Âµland 50 Âµ1; in other words, Appellants' "use of 4 Appeal2017-006328 Application 13/105,726 the term 'about' shows that [Appellants] did not intend to limit the claimed ranges to their exact end-points." In re Harris, 409 F.3d 1339, 1343 (Fed. Cir. 2005). Accordingly, we do not sustain the rejection of claims 1-15 and 22 as being indefinite. Rejection II Claims 1, 2, 4---6, 9, 11, 13, 15, and 22 Appellants present arguments for patentability of independent claims 1, 5, 11, and 13 collectively. Appeal Br. 7-23. We select claim 1 as representative and treat the other claims as standing or falling with representative claim 1. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). The Examiner finds that Brown discloses a method substantially as recited in independent claim 1, including, inter alia, obtaining a plurality of fluid samples simultaneously, but "does not explicitly disclose the use of the device in a blood vessel, or measuring the concentration of biomarkers in each of the samples." Final Act. 3-5. The Examiner further finds that "in Brown[']s disclosure [ofJ map[ping] the variation of characteristics in the samples along a linear direction, analysis would inherently need to be performed on the samples to obtain the characteristics." Id. at 5. The Examiner reasons that it would have been obvious to a skilled artisan "that concentration of biomarkers and analytes falls under Brown[']s description of analysis of the samples which includ[ e] diagnostic, chemical, genomic, and visual." Id. The Examiner finds that Brown discloses the sample volume may range from 1 pl to 100 Âµl, and determines that "Brown's range encompasses [Appellants'] claimed range of 10 Âµ1- 50 Âµland as such would 5 Appeal2017-006328 Application 13/105,726 have been obvious to one of ordinary skill in the art at the time of the invention to choose a volume within the claimed range." Id. at 6 ( citing Brown, 10:5---6). The Examiner determines that Appellants' Specification "does not provide a specific novel technical advantage to the use of the [recited] range," and, thus, selection of the recited range is an obvious design choice. Id. The Examiner finds that Wallace discloses a method of using a sampling device for sampling in a blood vessel, and reasons that it would have been obvious to one of ordinary skill in the art "to use Brown's device to collect fluid samples from a blood vessel as taught by Wallace in order to obtain a plurality of fluid blood samples along the length of a blood vessel." Id. at 4--5. Appellants provide a number of arguments traversing the rejection. Appeal Br. 7-23. First, Appellants argue that Brown is non-analogous and, therefore, cannot properly be used in an obviousness rejection. Id. at 8-16. Appellants cite extensively to the Declaration of Dr. Stephen Blatcher ("Blatcher Deel."), one of the inventors. Id. A reference qualifies as prior art for a determination under Â§ 103 when it is analogous to the claimed invention. In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). 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)). The field of endeavor is determined "by reference to explanations of the invention's subject matter in the patent 6 Appeal2017-006328 Application 13/105,726 application, including the embodiments, function, and structure of the claimed invention." Id.; see a !so l)en1.i ns!d, 796 F .2d at 442 (finding that if a prior art reference discloses essentially the same structure and function as the invention; it is likely in the same field of endeavor). Appellants argue that Brown is from a different field of endeavor because "[t]he claimed invention is directed to various methods that include collecting blood samples," and "Brown is directed to collection of tissue biopsies." Appeal Br. 8-9; see also Blatcher Deel. ,r,r 5-8. Appellants argue that Brown's device "includes a sharp tip 52 ... [that] is completely unsuitable for the claimed invention, which is channeled through a blood vessel for sampling the blood." Appeal Br. 9 (citing Brown, 7: 10); see also Blatcher Deel. ,r,r 9-12. Appellants argue that "the device in Brown allows for portions that 'deliberately break off during use', which is completely incompatible with being located in a blood vessel." Appeal Br. 9 ( citing Brown, 8:14--19); see also Blatcher Deel. ,r 12. Appellants argue that "Brown discloses a preferred sampling volume of less than 1.2 cubic millimeters," which "is far too small for the types of diagnostic chemistry analysis facilitated by the present invention." Appeal Br. 9 (citing Brown, 2:13, 5:26-27); see also Blatcher Deel. ,r 14. Appellants reproduce several portions of the Blatcher Declaration, and argue that the Examiner failed to consider the Blatcher Declaration. Appeal Br. 10-14. We are not persuaded by Appellants' arguments, which mischaracterize Brown's catheter. Contrary to Appellants' assertion that Brown is "directed to collection of tissue biopsies" (id. at 9; see also Blatcher Deel. ,r 8), Brown repeatedly discloses collection of fluid samples. For example, Brown discloses that the internal vacuum of its vacuum 7 Appeal2017-006328 Application 13/105,726 sampling device embodiment "draws either tissue or fluid from the exterior of the chamber 3 into the chamber 3." Brown, 9:15-16 (emphasis added); see also id. at 12: 19-21 ("mechanisms for collecting samples of tissue or fluids" (emphasis added)), 13:5 (contrasting biopsy and sampling). Contrary to the assertions of Appellants' declarant (see Blatcher Deel. ,r 9), this embodiment does not "need" material to be cut or include a blade; rather, Brown discloses that the covering material can be contoured to cut through material drawn into the cavity (Brown, 9 :24--26), which would be unnecessary for collecting fluid samples, and the referenced blade pertains to "[a]n additional embodiment" (id. at 9:31). Brown also refers to its device as "a biopsy and/or fluid sampling device." Id. at 1:30 (emphasis added). Thus, like Appellants' device, Brown discloses a catheter for collecting fluid samples. Regarding the "sharp tip 52" cited by Appellants, Brown discloses: "The catheter 50 includes a distal insertion end 52 and sampling devices 54. The distal end 52 is a sharp or pointed end that is inserted into the subject requiring removal of tissue or fluid samples." Id. at 7:9-11. That Brown uses a sharp or pointed tip does not differentiate Brown's field of endeavor from that of Appellants' claimed invention. Rather, like Appellants' device, Brown discloses a medical catheter for insertion into a patient for biopsy or other purposes. See id. at 7: 8-9. Regarding Appellants' assertion that Brown allows for portions to deliberately break off, Brown discloses that its sampling devices are fabricated with biodegradable polymers, and that the use of such polymers "allows implementations of this invention with portions that deliberately break off during use, are left within the body, and cause no harm." Brown, 8 Appeal2017-006328 Application 13/105,726 8:14--16. Continuing, Brown discloses that "[t]he sampling devices 54 need not be fabricated with biodegradable materials; however, use of biodegradable materials removes the danger associated with portions that break or fail during use." Id. at 8: 17-19. Thus, Brown contemplates implementations of its device that have portions that deliberately break off, but does not require such implementations as suggested by Appellants. A skilled artisan would not use such a frangible implementation where it would be undesired or dangerous to the patient. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,421 (2007) ("A person of ordinary skill is also a person of ordinary creativity, not an automaton."). Regarding the volume of Brown's sampling chambers, Appellants focus on the preferred volume to the exclusion of Brown's full disclosure. As correctly noted by the Examiner (see Final Act. 6, 10; Ans. 14), Brown discloses that"[ v ]olumes of such sampling chambers range from as small as about a picoliter or less and as large as about a few hundred microliters [(Âµl)] or more." Brown, 10:5---6. Thus, Brown discloses a volume ranging from 1x10-12 liter to at least 1x10-4 liter, which encompasses the volume range recited by Appellants. The additional assertions made by Appellants' declarant similarly fail to persuade us that Brown is not analogous to the claimed invention. For example, the declarant' s characterizations of Brown's catheter as being "stiff' and "inflexible" (see Blatcher Deel. ,r,r 10, 12) are unsupported by evidence or persuasive technical reasoning, and the Examiner does not suggest reusing Brown's catheter (see id. ,r 13). We additionally note that Dr. Blatcher is also an Inventor/ Appellant and, as such, the Declaration is less persuasive than that of a disinterested person. See In re McKenna, 203 9 Appeal2017-006328 Application 13/105,726 F.2d 717, 720 (CCPA 1953) ("[A]n affidavit by an applicant or co-applicant as to the advantages of his invention is less persuasive than one made by a disinterested person."). In view of the foregoing, we determine that a preponderance of the evidence supports the Examiner's determination that Brown is analogous to the claimed invention. See Ans. 10-11. Because both Appellants' method and Brown's device are directed to medical catheters for insertion into a patient for obtaining fluid samples, Brown is in the same field of endeavor as the claimed subject matter. Appellants next argue that Brown does not disclose "the use of the device for sampling blood." Appeal Br. 16; see also Reply Br. 12. According to Appellants, "Brown is directed to removing solid tissue or fluid using 'scrapping or cutting using a jaw or knife mechanism,"' and "[t]he use of sharp or cutting edges is completely unsuitable for the claimed invention." Appeal Br. 16 ( citing Brown, 3:5---6, 7: 10). We are not persuaded by Appellants' arguments. As noted above, Brown discloses a vacuum sampling device embodiment that draws fluid into its chambers and that does not use a jaw or knife mechanism. Additionally, as correctly noted by the Examiner (see Final Act. 3--4; Ans. 15-17), Brown discloses that "[t]he multiple sampling devices are positioned along the outer diameter of the shaft portion of a single catheter or other device, and samples are collected and stored in respective chambers of the sampling devices." Brown, 1:33-2:2; see also id. at Fig. 1. Appellants next argue that "[ o ]ne of ordinary skill in the art would not have modified the method of Brown to insert the catheter into a blood vessel to obtain a blood sample." Appeal Br. 18. Appellants argue that "[t]he 10 Appeal2017-006328 Application 13/105,726 Brown catheter is completely unsuitable for blood sampling" (id. ( citing Blatcher Deel. ,r 10)) and, because "Wallace is directed to a catheter used to enlarge the blood vessel, ... one [ ofJ ordinary skill in the art would not have turned to Wallace for any disclosure or teaching suggesting to use the device disclosed by Brown in a blood vessel" (id. at 19). Continuing, Appellants argue that because "[t]he catheter of Brown was suitable for its purpose ( e.g., collecting fluid samples from diseased areas) ... there would have been no reason for one of ordinary skill in the art to modify the catheter of Brown to collect blood samples." Id. Appellants argue that "neither Brown nor Wallace disclose how to use the microminature manufacturing technologies (Brown at p. 1) to make a catheter having the necessary dimensions to be inserted into a blood vessel." Id. We are not persuaded by Appellants' arguments. The assertion that Brown's device is unsuitable for use in a blood vessel is premised on Dr. Blatcher' s characterization of the Brown catheter as being stiff. Id. at 18 ( citing Blatcher Deel. ,r 10). However, as noted above, the declarant does not provide an evidentiary basis for this conclusory assertion. As for Brown's "pointed tip," the Examiner modifies Brown's device "as taught by Wallace," which discloses a catheter having distal end 40 designed to be pushed through an artery. Final Act. 4--5; Wallace ,r 28, Fig. 6; see also KSR, 550 U.S. at 421. As correctly noted by the Examiner, and as discussed above, Brown discloses the collection of fluid samples from a patient. Appellants fail to apprise us of error in the Examiner's determination that blood qualifies as such a fluid. See, e.g., Final Act. 9-10. Regarding Appellants' arguments regarding the manufacturing of Brown's modified device, Brown does not require any specific 11 Appeal2017-006328 Application 13/105,726 manufacturing method. The assertion that Brown's device would require "significant re-engineering" is premised on Dr. Blatcher' s characterization of the Brown catheter as being inflexible. Appeal Br. 19 ( citing Blatcher Deel. ,r,r 12-13). However, as noted above, the declarant does not provide an evidentiary basis for this conclusory assertion. Moreover, as flexible vascular catheters are well known, as evidenced, for example, by Wallace, Appellants fail to persuade us that forming Brown's device of a flexible material would be beyond the skill set of a person of ordinary skill in the art. Appellants next acknowledge that "Brown ... contains a general reference to the volume of a sampling chamber wherein the volumes 'range from as small as a picoliter or less and as large as about a few hundred microliters or more,"' but argue that "[t]here is no specific teaching of the claimed range." Appeal Br. 20. Appellants cite paragraph 14 of the Blatcher Declaration as establishing "evidence ... showing that [the] claimed range is critical for intra vascular blood sampling and analysis." Id. at20-2I. We are not persuaded by Appellants' arguments. As noted above, Brown's disclosed range fully encompasses the recited range. As such, the Examiner has established the recited range to be prima facie obvious. See In re Wertheim, 541 F.2d 257,267 (CCPA 1976). When an applicant seeks to overcome a prima facie case of obviousness by showing improved performance in a range that is within or overlaps with a range disclosed in the prior art, the applicant must "show that the [ claimed] range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997) (modification in original) (quoting In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)). 12 Appeal2017-006328 Application 13/105,726 Appellants have not made any such showing. The cited declaration testimony of Dr. Blatcher is of no avail, as Dr. Blatcher relies on the smaller preferred volume of less than 1.2 Âµl rather than the full disclosure of Brown. See Blatcher Deel. ,r 14. Notably, Dr. Blatcher testifies that a sample size of 1.2 Âµl is too small for certain (unrecited) blood analysis techniques, which is unpersuasive of the larger volumes disclosed by Brown. Id. Finally, Appellants argue that Brown does not disclose simultaneous sampling. Appeal Br. 21-22. According to Appellants, "the only application envisaged [in Brown] where only fluids are collected is one in which the device is left in situ for some time and the ports are opened in sequence to collect a series of fluid samples over time, rather than simultaneously." Id. at 22 (referring to Brown, 6:7-10). Appellants' arguments are in direct contrast to the disclosure of Brown, and, therefore, are unpersuasive. As discussed above, Brown repeatedly discloses collection of fluid samples. Brown further discloses that multiple samples can be collected simultaneously. See, e.g., Brown 5:20-21 ("The plurality of sampling devices are activated simultaneously such that multiple samples are achieved simultaneously."), 7:31-32 ("The sampling devices 54 are activated to extract samples simultaneously or separated in time."). Accordingly, for the foregoing reasons, we sustain the rejection of claims 1, 5, 11, and 13, and their dependent claims 2, 4, 6, 9, 15, and 22, which are not argued separately, as being unpatentable over Brown and Wallace. 13 Appeal2017-006328 Application 13/105,726 Claims 3, 7, 8, and 10-14 In addressing claims 3, 7, 8, and 10-14, the Examiner finds that "Brown discloses mapping variations in the characteristics of samples along a line or direction to evaluate the extent of change of sample characteristics and further uses an example of measuring tumor growth." Final Act. 7. The Examiner notes that "Brown discloses testing samples for diagnostic, genomic, chemical and other analytical methods," and reasons, therefore, that "it would have been obvious to one of ordinary skill in the art at the time of the invention to test the samples by known methods for different biomarkers/ characteristics of the samples depending on the disease/injury the user is studying and/or treating." Id. The Examiner finds that Brown's disclosure of mapping inherently discloses performing analyses on the collected samples. Id. at 5. The Examiner reasons that a skilled artisan would understand "that concentration of biomarkers and analytes falls under Browns description of analysis of the samples which includ[ e] diagnostic, chemical, genomic, and visual." Id. Appellants contest the rejection of claims 3, 7, 8, and 10-14, arguing that "[t]he Examiner's general contention regarding 'samples' is inapplicable to the claims, which are directed specifically to testing blood samples. Nowhere does Brown disclose testing blood samples for determining cardiovascular health." Appeal Br. 23. Appellants' arguments are not persuasive. As noted above, Brown discloses the collection of fluid samples from a patient and Appellants have not persuasively explained why blood would not qualify as such a fluid. Brown further discloses: The use of a plurality of sampling devices positioned along the perimeter of the catheter provides multiple samples with similar 14 Appeal2017-006328 Application 13/105,726 dimensions. The collection of multiple, similarly-sized samples permits the automation of sample analysis, whether chemical, visual, or genomic. In addition, the collection of multiple samples permits the mapping of tissue spatially with a higher resolution .... Brown, 6:4--8. Brown further discloses that the "sampling devices can be placed in a linear array along a biopsy device and then deployed simultaneously to map the variation of tissue in a given line or direction." Id. at 12:22-24. As acknowledged by Appellants (see, e.g., Appeal Br. 11 ( quoting Batcher Deel. ,r 8)), Brown discloses that its fluid and tissue sampling can be used in the field of cardiology. Id. at 1: 13-15. Appellants' declarant testifies that "analysis of blood proteins (i.e., cytokines) and lipids, which are considered to be the most important analytes for assessing disease state in cardiology," is "conventional." Blatcher Deel. ,r 14. Thus, we determine that a preponderance of the evidence supports the Examiner's determination that the recited testing of blood samples would have been obvious in view of Brown and Wallace. To the extent Appellants assert new arguments in the Reply Brief that were not included in the Appeal Brief and are not responsive to a new argument raised in the Answer, such arguments are untimely and will not be considered, in that Appellants fail to make a good faith showing why they could not have been timely presented in the Appeal Brief. See 37 C.F.R. Â§ 4I.41(b)(2). Accordingly, we sustain the rejection of claims 3, 7, 8, and 10-14 as being unpatentable over Brown and Wallace. DECISION The Examiner's decision to reject claims 1-15 and 22 as being indefinite is reversed. 15 Appeal2017-006328 Application 13/105,726 The Examiner's decision to reject claims 1-15 and 22 as being unpatentable over Brown and Wallace is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 16