Ex Parte Orome et alDownload PDFPatent Trial and Appeal BoardOct 23, 201713335587 (P.T.A.B. Oct. 23, 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. 13/335,587 12/22/2011 Amir Orome 101672.0157P 6426 34284 7590 Rutan & Tucker, LLP 611 ANTON BLVD SUITE 1400 COSTA MESA, CA 92626 10/25/2017 EXAMINER COOK, CHRISTOPHER L ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 10/25/2017 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): patents @ rutan. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AMIR OROME, ERIC W. LINDEKUGEL, PAUL D. MORGAN, and MATTHEW W. BROWN Appeal 2016-007210 Application 13/335,587 Technology Center 3700 Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and JOHN E. SCHNEIDER, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a needle guide assembly. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Statement of the Case Background “[Ejmbodiments of the present invention are directed to a needle guide assembly for inserting a needle into the body of a patient in order to access a subcutaneous target, such as a vessel” (Spec. 12). “[T]he needle 1 Appellants identify the Real Party in Interest as C.R. Bard, Inc. (see App. Br. 4). Appeal 2016-007210 Application 13/335,587 guide assembly ... is configured to at least indirectly and removably attach to an image producing device, such as an ultrasound probe” (Id.). The Claims Claims 1—8, 16, 18, 19, and 21—26 are on appeal. Independent claim 1 is representative and reads as follows: 1. A needle guide assembly, comprising: an image producing device; a needle guide body configured to at least indirectly and removably attach to the image producing device, the needle guide body laterally slidable with respect to the image producing device; a plurality of guide channels defined by the needle guide body, each of the plurality of guide channels defining a unique insertion angle with respect to a longitudinal axis of the image producing device and configured to receive needles of differing gauges; and a plurality of front faces that face radially outwardly away from the image producing device when attached to the image producing device, the plurality of front faces defined by the needle guide body, each of the plurality of front faces having a concavely shaped surface that slopes toward an open proximal end of one of the plurality of guide channels. The Issues2 A. The Examiner rejected claims 1, 2, 4, 6, 7, and 16 under 35 U.S.C. § 103(a) as obvious over Gorzitze,3 Floyd,4 and Arenson5 (Final Act. 3—8). 2 The Examiner withdrew the 35 U.S.C. § 112(b) rejection, so claim 26 is not subject to any pending rejection (see Ans. 2). 3 Gorzitze, US 2010/0160787 Al, published June 24, 2010. 2 Appeal 2016-007210 Application 13/335,587 B. The Examiner rejected claim 3 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd, Arenson, Welles,6 and Britt7 (Final Act. 8—9). C. The Examiner rejected claim 5 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd, Arenson, and Cermak8 (Final Act. 9-10). D. The Examiner rejected claims 8 and 24 under 35 U.S.C. § 103(a) as obvious over Gorzitze and Bonde9 (Final Act. 10—12). E. The Examiner rejected claims 18, 21, 22, and 2510 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu,* 11 “NSK”12 and “Slide-N-Fock”13 (Final Act. 12—14). F. The Examiner rejected claim 19 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu, “NSK”, “Slide-N-Fock”, and Cermak (Final Act. 15-16). G. The Examiner rejected claim 23 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu, “NSK”, “Slide-N-Fock”, Jaggi,14 and Dietz15 (Final Act. 16-17). 4 Floyd et al., US 2005/0131291 Al, published June 16, 2005. 5 Arenson et al., US 5,076,279, issued Dec. 31, 1991. 6 Welles, US 5,138,748, issued Aug. 18, 1992. 7 Britt, US 4,341,303, issued July 27, 1982. 8 Cermak et al., US 2009/0143684 Al, published June 4, 2009. 9 Bonde et al., US 2008/0300491 Al, published Dec. 4, 2008. 10 While the Examiner inadvertently omitted claim 25 from the statement of rejection, claim 25 was included in the body of the rejection, so we consider the rejection to include this claim. 11 Sandhu, US 6,485,426 B2, issued Nov. 26, 2002. 12 “NSK”, https://web.archive.Org/web/20091127094145/http:// www.nskamericas.com/cps/rde/xchg/na_en/hs.xsl/linear-guides.html (2009). 13 “Slide-N-Fock”, https:/web.archive.org/web/20081202134039/http: //www. hooverfence.com/tools/slide-n-lockhtm (2008). 14 Jaggi et al., US 6,425,871 Bl, issued July 30, 2002. 3 Appeal 2016-007210 Application 13/335,587 A. 35 U.S.C. § 103(a) over Gorzitze, Floyd, andArenson The Examiner finds Gorzitze teaches an ultrasound system with “a linear needle guide 750 including a top surface 752 and a plurality of needle channels 354 that are each aligned to define differing needle insertion angles” (Final Act. 3—4). The Examiner finds Gorzitze teaches “different insertion angles correspond to different subcutaneous depths” (Id.). The Examiner finds that either Figure 4 A of Gorzitze is “considered to depict wherein a portion of the front face extends ‘radially, outwardly away’ from the image producing device in its broadest reasonable interpretation” or that the “mere change in shape (e.g. angle) of the front face is considered to be an obvious design choice” (Final Act. 6). The Examiner finds that Floyd teaches “ultrasound needle guide arrangements where a front face is angled away from the probe before merging into the needle guide channel that angles back toward the probe” (Id.). The Examiner also finds Arenson teaches “a guide body (20) having a ‘front face’ which extends radially away from the probe (See Fig. 3) and that includes a ‘funnel-shaped depression’ (25) to aid in inserting the needle into the slot” (Final Act. 6—7). The Examiner finds it obvious to incorporate the configurations of Floyd or Arenson into the device of Gorzitze because either “such a modification merely involves a simple substitution of one known needle guide arrangement for another” or “to easily and efficiently guide needle tip into a desired channel” (Final Act. 6, 8). 15 Dietz et al., US 6,840,954 B2, issued Jan. 11, 2005. 4 Appeal 2016-007210 Application 13/335,587 The issue with respect to these rejections is: Does the evidence of record support the Examiner’s conclusion that Gorzitze, Floyd, and Arenson render claims 1 and 16 obvious? Findings of Fact 1. Figure 7 of the Specification is reproduced below: Figure 7 shows a “needle . . . can then be inserted through the guide channel and into the patient’s skin while the probe 50 is held in place against the skin to continue imaging the target” (Spec. 134). 2. Gorzitze teaches “needle guide systems for a sonography device. The needle guide systems include both fixed and adjustable needle guides for use with a probe of the sonography device” (Gorzitze 12). 5 Appeal 2016-007210 Application 13/335,587 3. Figure 13 of Gorzitze is reproduced, in part, below: “In FIG. 13, a semi-circular needle guide 850 is shown, including a top surface 852 on which a plurality of needle channels 354 are disposed in a fan pattern, each needle channel defining a different needle insertion angle” relative to the ultrasound probe body 18 (Gorzitze 143). 4. Figures 9D of Grozitze and the Examiner’s annotated description of figure 9E are reproduced below: Figures 9D and 9E depict “a variation of the needle guide 450” (Gorzitze 1 39). Figures 9D and 9E also show “a needle channel 454 defined by lips 6 Appeal 2016-007210 Application 13/335,587 455 and on a bottom surface a connector 456 for attaching the needle guide 450 to the probe 18” (Gorzitze 135). 5. Figure 8B of Floyd is reproduced below: FIG. 8B Figure 8B shows needle guide 20 “is a device for holding a needle . . . within groove 22. . . . guide 20 is rotated toward probe 10 and snaps in position . . . releaseably locking on edge 21 of device 20” (Floyd 123). 6. Figure 3 of Arenson is reproduced below: Figure 3 shows “needle guide 10 has a through guide slot 11 which receives and guides a biopsy needle 12 for exit along the guide slot axis 13 to enable 7 Appeal 2016-007210 Application 13/335,587 puncture of the patient’s skin 14 as at 15 and permit insertion into the patient along an extension of the guide slot axis 13” (Arenson 2:21—26). 7. The Examiner’s marked up Figure 8 of Arenson is reproduced below: Figure 8 shows the “needle guide body may have a funnel-shaped depression 25 ... to aid in inserting a needle into the guide slot” (Arenson 2:46-47). Principles of Law A prima facie case for obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Appellants contend “the alleged front face of Gorzitze with the alleged concave surface does not face outwardly in a radial direction away 8 Appeal 2016-007210 Application 13/335,587 from the ultrasound probe; rather, the channel is on the surface that faces radially outwardly” (App. Br. 10). Appellants also contend “the front faces of the described embodiments in Floyd and Arenson also face in a direction parallel to the probe surface similar to that of Gorzitze” (Id. at 11). Appellants contend “that if the front faces were modified to face radially outwardly away, the needle channel would be directed into the surface of the probe instead of in front of the probe as intended. It would not be an obvious design choice given that the Gorzitze needle channel would be rendered inoperable” (App. Br. 11). The Examiner responds the radial facing limitation “is extremely broad given that Appellant has failed to specify a specific radial direction or value (e.g. angle). Thus, any surface (e.g. face) of a needle guide which extends away from the ultrasound probe would meet the argued claim limitation” (Ans. 3). The Examiner finds “Floyd’s faces do not face in a direction parallel to the probe surface in its broadest reasonable interpretation” (Id. at 7). The Examiner finds “Arenson’s faces do not face in a direction parallel to the probe surface in its broadest reasonable interpretation” (Id. at 8). We find that Appellants have the better position. In particular, we agree that the broadest reasonable interpretation of “front faces that face radially outwardly away from the image producing device” is read in light of Figure 7 (FF 1) and the Specification’s teaching that “each front face 22 A- 22C is oriented so as to be disposed at substantially a right angle with the longitudinal length of the respective guide channel 20A-20C” (Spec. 121). Therefore, we interpret this limitation as requiring an orientation where front 9 Appeal 2016-007210 Application 13/335,587 face is “the face that primarily faces away from the probe in a radial direction” (Reply Br. 4). Under this interpretation, we agree with Appellants that the front faces of Gorzitze, Floyd, and Arenson do not face substantially radially outwardly from their respective image producing devices as required by claims 1 and 16. With regard to the Examiner’s design choice argument, there is no evidence or reasoning establishing that this particular change in orientation of the needle assembly, which results in insertion of the needle in a different orientation than that disclosed by Gorzitze, Floyd, or Arenson, would have been a simple design choice. By contrast, Appellants have provided specific reasons why they chose this orientation, because the “front faces 22A-22C of the needle guide body 12 in FIG. 6 are marked with a depth number indicating the depth at which a needle inserted through the corresponding guide channel 20A-20C would intercept the plane of the image produced by the ultrasound probe” (Spec. 131). See In re Chu, 66 F.3d 292, 299 (Fed.Cir.1995) (finding of “obvious design choice” precluded where the claimed structure and the function it performs are different from the prior art). Here, while all of the prior art is drawn to needle guide assemblies, the Examiner has not established a reason for the modification to the orientation of the needle face. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Gorzitze, Floyd, and Arenson render claims 1 and 16 obvious. 10 Appeal 2016-007210 Application 13/335,587 B.-C. 35 U.S.C. § 103(a) These rejections rely upon the underlying obviousness rejection over Gorzitze, Floyd, and Arenson. Having reversed the rejection of claim 1, we also necessarily reverse these obviousness rejections because the Examiner does not identify where Welles, Britt, or Cermak suggest “front faces that face radially outwardly away from the image producing device” as required by claim 1. D. 35 U.S.C. § 103(a) over Gorzitze andBonde The Examiner finds Gorzitze teaches “a linear needle guide 750 including a top surface 752 and a plurality of needle channels 354 that are each aligned to define differing needle insertion angles” where “different insertion angles correspond to different subcutaneous depths” and “a particular needle channel may be selected for use by laterally sliding the needle guide” (Final Act. 10-11). The Examiner “Bonde teaches parallel channels” (Ans. 11). The Examiner finds it obvious to modify “the shape of the surface 752 as described by Gorzitze (Fig. 12) to provide a stepped platform for each needle guide as described by Bonde in order to alter the orientation of each needle guide with respect to the imaging region” (Final Act. 11). The issue with respect to these rejections is: Does the evidence of record support the Examiner’s conclusion that Gorzitze and Bonde render claims 8 and 24 obvious? Findings of Fact 8. Gorzitze teaches “a plurality of needle channels 354 that are each aligned to define differing needle insertion angles. A particular needle 11 Appeal 2016-007210 Application 13/335,587 channel can be selected for use by laterally sliding the needle guide 750” (Gorzitze 143). 9. Figure 8 of Bonde is reproduced below: FIGURE 8 FIG. 8 further illustrates plate 81 including pointers 811, 812, 813, which extend over a length along an exposed surface of 12 Appeal 2016-007210 Application 13/335,587 plate 81; pointers 811, 812, 813 may be formed as grooves or protruding surfaces, or any other type of marking on the exposed surface of plate 81. According to the illustrated embodiment, each of pointers 811, 812, 813 extend at a fixed angle ((> with respect to plane 2, and are space apart from one another in a direction approximately parallel with plane 2; each of pointers 811, 812, 813 points to a needle entry site El, E2, E3, respectively, each of which corresponds to a depth of a target TD1, TD2, TD3, respectively, and depending on which depth is measured for the target, the corresponding pointer is selected to guide insertion of a percutaneous needle. (Bonde 141). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 10—12; FF 2-4, 8, 9) and agree that claims 8 and 24 are rendered obvious by Gorzitze and Bonde. We address Appellants’ arguments below. Appellants contend “the embodiment relied upon in the Office Action, i.e., FIG. 8 of Bonde, is designed as a ‘fixed needle guide’ that does not slide laterally across a surface” (App. Br. 14). We find this argument unpersuasive because Bonde suggests a “particular needle channel can be selected for use by laterally sliding the needle guide” (FF 8), expressly teaching the limitation “hat the needle guide body can be slid laterally across a surface of the ultrasound probe” in claim 8. 13 Appeal 2016-007210 Application 13/335,587 Appellants contend “neither Gorzitze nor Bonde discloses a guide channel being ‘parallel’ to another guide channel as required” (App. Br. 14). Appellants also contend the alleged pointers 811, 812, and 813 in Bonde are not separate platforms with a guide channel in each platform, and they are not spaced apart in a lateral direction or direction the guide would slide across a surface of the probe. Further, the pointers are part of a guide body that cannot slide at all. Nothing cited teaches parallel guide channels on multiple different platforms spaced laterally in a direction the guide body slides. (Reply Br. 9). We do not find these arguments persuasive because they fail to combine the teachings of Gorzitze and Bonde. Gorzitze teaches a “plurality of needle channels 354 that are each aligned to define differing needle insertion angles” (FF 8), thereby suggesting a needle guide with multiple channels. While Gorzitze does not teach the guide channels are parallel, Bonde teaches parallel pointers for insertion, Bonde teaches “each of pointers 811, 812, 813 points to a needle entry site El, E2, E3” (FF 9). Therefore, the ordinary artisan interested in needle channels for each of the parallel needle entry sites of Bonde would have reasonably utilized the needle guide assembly of Gorzitze to permit lateral movement of the needle guide on the ultrasound probe body (FF 8—9). “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). In determining obviousness, furthermore, a reference “must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” Id. 14 Appeal 2016-007210 Application 13/335,587 Appellants contend “modifying Gorzitze to have parallel channels would render it unsuitable for its intended purpose” (App. Br. 14). We find this argument unpersuasive because Appellants provide no reason or evidence why the modification would render Gorzitze unsuitable. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). See also In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (Arguments and conclusions unsupported by factual evidence carry no evidentiary weight.) Appellants also contend, regarding claim 24, that the “Examiner has not cited anything in the asserted art that expressly discloses ‘the guide channel of each platform is slid laterally across the surface of the ultrasound probe to alternately center the guide channel of each platform with respect to the ultrasound probe,’ as claimed” (App. Br. 15). We find this argument unpersuasive because this limitation of claim 24 is drawn to an intended use of the obvious needle guide assembly, and no specific structural element is required by claim 24. “[Apparatus claims cover what a device is, not what a device does.'” Hewlett-Packard Co. v. Bausch &Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). Merely stating an intended use for an apparatus is not sufficient to distinguish the apparatus from the prior art. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Conclusion of Law The evidence of record supports the Examiner’s conclusion that Gorzitze and Bonde render claims 8 and 24 obvious. 15 Appeal 2016-007210 Application 13/335,587 E—G. 35 U.S.C. § 103(a) over Gorzitze, Sandhu, “NSK”, “Slide-N-Lock” and Cermak, Jaggi, and Dietz Because these rejections all turn on the same issue, we will consider them together. Appellants contend the cited art does not show or describe “when the protrusion is received within one of the one or more openings, the protrusion is not visible to a user of the system viewing the needle guide body.” The Office Action relies on Sandhu; however, the alleged protrusion (dowel/pin fastener) in Sandhu is always visible when Sandhu is in use because the dowel/pin fastener extends outside of the holes 112 of Sandhu. (App. Br. 15). The Examiner responds the amended limitations are purely directed toward the intended use of the ultrasound and do not further define any already claimed structure. Alternatively, it must be noted that the needle guide extends beyond the width of the probe. Thus, one standing behind the device would be unable to view the protrusion when the guide is slid and also could be “viewing the needle guide ” in its broadest reasonable interpretation. (Ans. 12). The Examiner also contends “the top surface described by Gorzitze would appear to block any locking pin or protrusion designed to enable linear movement along a rail as depicted by ‘NSK NPL’” (Ans. 12). We find that Appellants have the better position. We agree with Appellants that the limitation “the protrusion is not visible to a user” is structural, not intended use, because the needle guide assembly must structurally permit a protrusion that is not visible to satisfy claim 18. 16 Appeal 2016-007210 Application 13/335,587 We are not persuaded by the Examiner’s argument that based on the position of the user, the “protrusion is not visible”, because by that reasoning, the visibility of the protrusion depends upon the user’s position, not that of the protrusion. That is, the Examiner’s reasoning would allow the claim to be satisfied for a user behind the device but not satisfied by a user in front of the device. We interpret the “not visible” requirement as applying to any user in in any ordinary location relative to the needle guide assembly, and therefore find the Examiner’s position unpersuasive. We reverse the rejection of claim 18, and necessarily reverse the further obviousness rejections including Cermak, Jaggi, and Dietz because the Examiner does not identify where these references suggest “the protrusion is not visible to a user.” SUMMARY In summary, we reverse the rejection of • claims 1, 2, 4, 6, 7, and 16 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd, and Arenson. • claim 3 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd, Arenson, Welles, and Britt. • claim 5 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd, Arenson, and Cermak. • claims 18, 21, 22, and 25 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu, “NSK” and “Slide-N-Lock”. • claim 19 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu, “NSK”, “Slide-N-Lock”, and Cermak. 17 Appeal 2016-007210 Application 13/335,587 • claim 23 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu, “NSK”, “Slide-N-Lock”, Jaggi, and Dietz. We affirm the rejection of claims 8 and 24 under 35 U.S.C. § 103(a) as obvious over Gorzitze and Bonde. 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 18 Copy with citationCopy as parenthetical citation