Ex Parte RaczDownload PDFPatent Trial and Appeal BoardOct 31, 201611853785 (P.T.A.B. Oct. 31, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111853,785 09/11/2007 63467 7590 Ramey & Schwaller, LLP 5020 Montrose Blvd. Suite 750 Houston, TX 77006 11/02/2016 FIRST NAMED INVENTOR N. Sandor Racz 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. 20029.0003.NPUSOO 3648 EXAMINER BOSWORTH, KAMI A ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 11/02/2016 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): uspto@rameyfirm.com wramey@rameyfirm.com bwilliams@rameyfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte N. SANDOR RACZ Appeal2014-006943 Application 11/853,785 1 Technology Center 3700 Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to a surgical needle. The '785 Application discloses that the needle can be used for spinal aesthesia and nerve blockade. '785 Application 1: 8-17; 3 :2-31. The Examiner finally rejected the claims as obvious under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 134. The Examiner's decision is affirmed. 1 "The '785 Application." Appeal2014-006943 Application 11/853,785 STATEMENT OF CASE Appellant appeals from the Examiner's final rejection of claims 1, 3- 9, 11, 12, 22, 23, and 25. The claims stand rejected by the Examiner as follows: 1. Claims 1, 3, 4, 11, 12, and 22 as obvious under 35 U.S.C. § 103(a) (pre-AIA) in view of Wang (U.S. Patent No. 5,320,110, patented June 14, 1994) and Racz (U.S. Patent No. 5,817,074, patented Oct. 6, 1998). Final Rej. 2. 2. Claims 5-9 as obvious under 35 U.S.C. § 103(a) (pre-AIA) in view of Wang, Racz, and Van Tassel (U.S. Publ. Application No. 2003/0130626 Al, pub. July 10, 2003). Final Rej. 6. 3. Claims 23 and 25 obvious under 35 U.S.C. § 103(a) (pre-AIA) in view of Wang, Racz, and Yamamoto (U.S. Publ. Application No. 2004/0260241 Al, pub. Dec. 23, 2004). Final Rej. 8. Claim 1 is illustrative of the claimed subject matter: 1. A surgical instrument, in a unitary arrangement, compnsmg: an elongated, at least partially hollow nerve blocking needle shaft comprising a tip end and a connector end; wherein the tip end is closed; and wherein the tip end comprises at least two facets; wherein the tip end comprises a shoulder and at least one beveled edge extending from the shoulder to a point of the tip end· ' wherein the tip end is capable of insertion into a tissue of a patient, but the tip end is not as sharp as a needle point; at least one side port located along the elongated, at least partially hollow shaft away from the closed tip end and separated from the shoulder by a distance of about 1 mm to 4 mm; 2 Appeal2014-006943 Application 11/853,785 wherein the at least one side port has at least one of an inwardly beveled edge or an outwardly beveled edge; and wherein the tip end is able to enter at least one tissue without the assist of an introducer. OBVIOUSNESS IN VIEW OF WANG AND RACZ The Examiner found that Wang describes a surgical needle with the features of the claimed instrument, but not where the needle's side port is "located ... away from the closed tip end and separated from the shoulder by a distance of about 1 mm to 4 mm" and not where the "side port has at least one of an inwardly beveled edge or an outwardly beveled edge." Final Rej. 2-3 (claim 1). However, the Examiner found that Racz describes a surgical needle with both features. Id. at 3. The Examiner found it obvious to modify Wang with these feature for the purpose of dispersing the agent in a desired location. Id. Side port location Wang teaches that side port ("aperture") "located about 4 mm and 7 mm, respectively, axially rearwardly from tip 171 of trocar 166." Wang, col. 8, 11. 3---6. Appellant contends that the claim "requires that the side port be separated from the shoulder by a distance of about 1 mm to 4 mm," while "Figs. 2 and 4 [of Wang] depict that the side port distance is measured to the edge of the side port closest to the tip." Reply Br. 27. For this reason, Appellant contends that Wang results in the side port being located in a different position than claimed. Id. at 27-28. Appellant further argues that the skilled worker would not have combined Wang and Racz because the instruments have different purposes. Appeal Br. 26-27; Reply Br. 28. 3 Appeal2014-006943 Application 11/853,785 Fig. 2 of the '785 Application shows the distance between port 30 and shoulder 26. The shoulder 26 is shown as the distal leading edge from point 33 of the needle. Wang teaches that the port is a distance away from the point 171 of the needle (shown in Fig. 13 of Wang). Wang, however, teaches: Outer trocar 166 is tubular with a hollow interior, and has a distally positioned notch 168 and an aperture 170 positioned to extend through the trocar side wall opposite notch 168. The exact positioning of this aperture 170 is not critical but is preferably in the proximal half of the waU opposite notch 168. In this embodiment, notch 168 begins and the aperture is located about 5 mm and 7 mm, respectively, axially rearwardly from the tip 171 of trocar 166. \Vang, col. 7, l. 66 to col. 8, l. 6 (emphasis in italic added). Since \Vang is measured from the tip of the needle (proximal end), while the claimed distance is from the shoulder of the tip- a more distal location with respect the needle tip - a location of 4 mm from the shoulder would be located even further away from the needle tip. Thus, 4 mm from the shoulder as recited in claim l would be nwre than 4 rnm away when measured from the tip of the needle as taught by \Vang. In other words, the value of about 4 mm from the needle shoulder as recited in the claim is equivalent to 4 mm plus the distance from the shoulder to the needle tip. \Vbile there is no information on the distance between the shoulder and needle tip, it is evident that the claimed value of "about" 4 mm is more than about 4 mm, which brings it closer to the "about 5 mm" described by \Vang. Wang, col. 8, 11. 3---6. The claim requires a distance of "about l mm to 4 mm" from the shoulder. The term "about" is a word of approximation, indicating that the location is not exactly 4 mm from the shoulder. Appellant did not provide a 4 Appeal2014-006943 Application 11/853,785 definition of ''abouf' that would exclude it from c01Tesponding to the "about 5 mm" value disclosed by \Vang (at col. 8, 11. 3---6). We conclude that the term "about," coupled with the fact that Wang's port location is measured from the needle tip, and not the needle shoulder, makes it reasonable to find that \Vang's port ("about 5 mm") encompasses distances at the same or at overlapping locations as required by the claim. It is well established that, when there is a range disclosed in the prior art, and the claimed invention overlaps or falls within that range, there is a presumption of obviousness. Jn re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); Iron Grip Barbell Co .. Inc. v. U51~4 Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Even if the location values do not precisely overlap, they "are so close that prima facie one skilled in the art would have expected them to have the same properties," shifting the burden to the applicant to show they are different. Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985). In addition to these facts, Wang expressly teaches that "[t]he exact positioning of this aperture 170 is not critical but is preferably in the proximal half of the wall opposite notch 168." \Vang, col. 8, 11. 1-3. Thus, while the aperture in \Vang is preferably about 5 nun and 7 rnmm from the needle tip, \Vang explicitly teaches its placement is not critical. Consequently, we conclude that the claimed distance of about 4 mm is reasonably suggested by Wang. Appellant also argues that the "fluid mechanics of a side port 1 to 4 mm away from open tip end would be different than the fluid mechanics of a side port 1 to 4 mm from closed tip end." Appeal Br. 28. However, Appellant has not provided evidence of this. An argument made by counsel 5 Appeal2014-006943 Application 11/853,785 in a brief does not substitute for evidence lacking in the record. Estee Lauder Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). Because \Vang alone is adequate to meet the limitation of the location of the port, we find it unnecessary to reach the teachings in Racz with respect to this feature. CJ In re Boyer, 363 F.2d 455, 458 n.2 (CCPA 1966). Needle point Claim I recites that "the tip end is capable of insertion into a tissue of a patient, but the tip end is not as sharp as a needle point." The tip is required by the claim to have "at least one beveled edge extending from the shoulder to a point of the tip end." As found by the Examiner, Wang describes a tip "sharpened" with beveled edges. Wang, col. 8, 11. 6-7. The Examiner also found that "needle points come in various degrees of sharpness." Answer 14. Appellant contends that Wang teaches that its needle is sharp (Appeal Br. 28), but doesn't explain how the claimed needle with at least beveled edge wouldn't be as "sharp" as Wang's needle with the same features. Furthermore, Wang doesn't require the tip to be sharpened, but discloses that it is "preferably sharpened." Id. Consequently, a preponderance of the evidence supports the Examiner's finding that Wang discloses or reasonably suggests the claimed limitation of a "tip end is not as sharp as a needle point." Bevel andfacet Claim 1 requires that the "tip end comprises at least two facets" and "the tip end comprises a shoulder and at least one beveled edge." Claim 4, 6 Appeal2014-006943 Application 11/853,785 which depends from claim 1, further recites "tip end comprises at least two beveled edges." The Examiner found that Wang teaches "the tip end comprises at least two facets ('beveled surfaces'; Col 8, Line 7); wherein the tip end comprises a shoulder and at least one beveled edge extending from the shoulder to a point of the tip end (as seen in Fig 13 and 14 ... )." Final Rej. 2. Appellant contends that the Examiner has used the terms bevel and facet interchangeably. Relying on a dictionary definition, Appellant argues that a "facet" is a level plane, while a "bevel" is angled. Appeal Br. 29. This argument is not persuasive. During patent examination: [T]he PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in 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. Irz re Morris; 127 F.3d 1048; 1054 (Fed. Cir. 1997). In this case, the '785 Application discloses that the "angle of bevel is capable of being the same for all facets." '785 Application 9:2. Based on this description, the skilled worker reading the '785 Application would have understood that a "facet" can be a "bevel." Wang, as found by the Examiner, describes the tip of its instrument as having "beveled surfaces" (Wang, col. 8, 11. 6-7) and shows two beveled surfaces in Fig. 13. Consequently, Wang teaches a tip with at least two facets ("beveled surfaces"), where one of these facets is beveled, as required by claim 1. The claim also requires "at least one side port has at least one of an inwardly beveled edge or an outwardly beveled edge." The Examiner found that Racz describes a side port having "a beveled edge (as seen in Fig 2,3)." 7 Appeal2014-006943 Application 11/853,785 Final Rej. 3. Appellant contends that this feature is not described by Racz. Reply Br. 26. Although the Examiner found that this feature was met by Racz in the Rejection dated Feb. 7, 2013, Appellant did not respond until the Reply Brief. The Board will not considered new arguments "not raised in the appeal brief, or is not responsive to an argument raised in the examiner's answer ... unless good cause is shown." 37 CFR41.41(b)(2). Appellant did not explain why they waited until after the Appeal Brief to respond. Consequently, we shall not consider this new argument. Claim 11 Claim 11 has substantially the same structural limitations as claim 1, but further recites: the surgical instrument realizes at least one benefit selected from the group consisting of enhanced injection characteristics, increased operational efficiency, reduced cost per unit, reduced incidence of injury through intraneural/intravascular injection, and reduced incidence of injury through pricking/piercing. As discussed above, the cited prior art reasonably suggests all the structural features of claim 1, including the position of the side port. Absent evidence to the contrary, utilizing a needle with such features would result in the recited benefits. Appellant argues that the location of the side port would result in at least one of the claimed benefits. Appeal Br. 31. Appellant also makes the same unsubstantiated argument about how the position of the port affects the fluid mechanics. Id. However, since Wang discloses or reasonably suggests such a location, we conclude that such benefits would be an inherent property of placing the port in such location. Appellant did not provide 8 Appeal2014-006943 Application 11/853,785 evidence that such benefit was unexpected nor absent from the needle of Wang. Consequently, we affirm the rejection of claim 11. Claim 12 Claim 12, depends from claim 11, and further recites "wherein the connection is a plug and use connection." The Examiner found this limitation met by Wang's teaching of a proximal end "secured in a needle support." Final Rej. 5. Appellant contends that Wang does not describe a wire connector. Appeal Br. 32. Appellant's argument is not persuasive. Claim 12 does not require a wire plug and use connection. We do not read limitations into the claim. Nevertheless, the Examiner found that a plug and use connector explicitly comprising a wire as recited in claims 5 and 7-9 is described by VanTassel in combination with Wang and Racz. Final Rej. 7. Claim 22 Appellant provides separate arguments for independent claim 22. However, these arguments are the same as those found unpersuasive regarding claims 1 and 11. Summary The obviousness rejection of claims 1, 3, 4, 11, 12, and 22 is affirmed. To the extent claims were not argued separately, they fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). 9 Appeal2014-006943 Application 11/853,785 OBVIOUSNESS IN VIEW OF WANG, RACZ, AND VANTASSEL Claims 5-9 depend from claim 1 and further require a wire plug and use connector (claims 5 and 7-9) and an insulation around the shaft of the needle (claim 6). The Examiner found that these limitations are described in VanTassel. Final Rej. 7-8. The Examiner explained why it would have been obvious to one of ordinary skill in the art to have added such features to Wang. Id. Appellant makes the same unpersuasive arguments as for claim 1. Appeal Br. 34--36. Consequently, we affirm the rejection of claims 5-9 for the reasons set forth by the Examiner. OBVIOUSNESS IN VIEW OF WANG, RACZ, AND YAMAMOTO Claims 23 and 25 have substantially the same limitations as claim, but further require insulation along the needle shaft. The Examiner found that Yamamoto describes insulation that meets the claim limitation and explained why it would have been obvious to one of ordinary skill in the art to apply Yamamoto' s teaching to Wang and Racz. Final Rej. 10-11. Appellant makes the same unpersuasive arguments as they did for claims 1, 11, and 22. Consequently, we affirm the rejection of claims 23 and 25 for the reasons set forth by the Examiner. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation