Ex Parte Mackool

Patent Trial and Appeal BoardNov 21, 2012

12350294 (P.T.A.B. Nov. 21, 2012)

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. 12/350,294 01/08/2009 Richard J. Mackool 2839A 6657 63704 7590 11/23/2012 HESS PATENT LAW FIRM, P.C. 9 MIRAMAR LANE STAMFORD, CT 06902 EXAMINER KISH, JAMES M ART UNIT PAPER NUMBER 3737 MAIL DATE DELIVERY MODE 11/23/2012 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 PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ALCON, INC.1 (Application 12/350,294) ____________ Appeal 2011-006283 from Technology Center 3700 James M. Kish, Examiner ____________ Before RICHARD TORCZON, SALLY C. MEDLEY and JOSIAH C. COCKS, Administrative Patent Judges. TORCZON, Administrative Patent Judge. DECISION on rehearing 35 U.S.C. 6(c) The board previously affirmed rejection of claims 1-11 and 14-18, but reversed the rejection of claims 12 and 13. The appellant (Alcon) seeks relief from the portion of the decision on appeal affirming rejection of claims 1-11 and 14-18. 1 As noted in the decision on appeal, Office records show a different assignee. http://assignments.uspto.gov/assignments/q?db=pat&pub=20090124960 (visited November 2012). See 37 C.F.R. Â§ 41.8(a) (regarding notice of real party-in- interest). Appeal 2011-006283 Application 12/350,294 2 We have reconsidered the decision and modify the opinion as discussed below, but DENY the requested relief. OPINION Alcon identifies two basic errors: one involving claim interpretation and one involving analogous art. CLAIM INTERPRETATION Alcon contends that the board prejudicially erred in construing "along the hub of the hollow needle" to include the tip of the needle.2 Claim 1, one of two independent claims, is representative of the claims on appeal for purposes of this discussion and defines the invention as:3 1. A method of detecting and responding to a thermal condition during phacoemulsification, comprising performing phacoemulsification with a surgical instrument operative to vibrate a hollow needle with a driver at a speed of vibration and to aspirate fluid under suction through the hollow needle, the hollow needle terminating at a distal end into a tip and having a hub spaced from the tip, aiming a thermal imaging or thermal recognition source at a location selected from a group consisting of along the hub of the hollow needle of the surgical instrument and at the driver of the hollow needle of the surgical instrument so as to detect infrared radiation wavelengths emanating from the location, evaluating the detected infrared radiation wavelengths to make a determination as to whether a thermal condition has been reached; 2 Reh'g 2. 3 All claim language is taken from the claim appendix in Alcon's appeal brief. Emphasis has been added for contested language. Indenting has been added as appropriate. 37 C.F.R. Â§ 1.75(i). Appeal 2011-006283 Application 12/350,294 3 generating command signals in response to the determination being that the thermal condition has been reached; and varying at least one of the speed of vibration and a relative position of the hollow needle of the surgical instrument in response to the command signals. In the opinion, we stated:4 A second problem is that "along the hub of the hollow needle" does not exclude the portion of the hub that is proximal to the tip of the needle or even the tip itself, which appears in Figure 1 to be simply the terminus of the hub (with the suction port being the terminus of the aspiration passage). Indeed, during operation, the location of the tip or the tip-proximal part of the hub could also adjoin the affected tissue, which means sensing at the tissue/hub intersection would meet the broadest reasonable interpretation of the claim. Alcon correctly notes that the phrase "even the tip itself" is not consistent with the express claim limitation "having a hub spaced from the tip". The hub cannot both include the tip and be spaced apart from the tip. The phrase improperly incorporated the embodiment from Alcon's specification and Figure 1 into the claim.5 The original opinion must be modified to delete the phrase: or even the tip itself, which appears in Figure 1 to be simply the terminus of the hub (with the suction port being the terminus of the aspiration passage) Deletion of the phrase does not resolve the question of patentability, however. The demarcation between what is "spaced from the tip" and what is "proximal to the tip" remains unclear.6 This demarcation is critical because the 4 Decision 4 (emphasis added). 5 In re Priest, 582 F.2d 33, 37 (CCPA 1978) (explaining that the board may not read limitations into a claim from the specification). 6 See Decision 3 ("The figure does not demarcate the extent of the portion of the hub that is proximal to the needle tip.") Appeal 2011-006283 Application 12/350,294 4 affirmed portion of the final rejection does not require sensing at the tip: sensing at a location "proximal to the tip or at the target sight" is sufficient to affirm. For interpreting a claim, the best source of meaning is the plain language of the claim, followed by the specification, with other sources such as dictionaries being less favored. In the present case, the claim language does not provide a clear meaning for "spaced from the tip" other than that it cannot include the tip itself. The specification itself does not use the phrase so it does not directly resolve the question, but its discussion of the hub is instructive. Alcon's specification has the following to say about the hub (emphasis added): [0008] Another aspect of the invention resides in carrying out the detecting of infrared radiation wavelengths at a location along the surgical instrument other than at the needle tip, such as proximal to the needle tip, at the needle hub or at the needle driver. [0020] A conventional surgical instrument 24 to effect phacoemulsification is shown in Figs. 1 and 2. It includes a needle 26 having a suction port 28 at its tip 30, an aspiration flow passage 32 within a hub 34 that permits an aspiration flow from the suction port 28 to a discharge, which may be attached to a suction device (not shown) such as a vacuum. [0026] The '693 patent calls for monitoring the temperature on the outerÂ· surface of the ultrasonic needle. However, I have conducted experimentation that indicates that the greatest temperature elevation may actually occur proximal to the tip of the needle 26, such as along its hub 34 or even in the ultrasonic handpiece/metallic "driver" 36 to which the needle is attached (the ultrasonic handpiece/driver 36 is in turn connected to the ultrasonically vibratable material which is either a piezoelectric crystal or metallic, i.e., nickel). [0027] The elevated temperature in either the ultrasonic handpiece/driver 36 or the needle hub 34 can rapidly spread to the needle tip 30 (and thus to the tissues of the eye that surround the needle tip 30). Therefore, monitoring the former areas should be done and the operation of the surgical instrument 24 should be modified to respond to temperature elevation in these regions (or even more simply to respond to the greatest temperature detected at any location within the surgical field) by Appeal 2011-006283 Application 12/350,294 5 discontinuing the ultrasonic vibration if a certain critical temperature is reached. Paragraph 0008 suggests that the needle hub might not be proximal to the needle tip because they are separate items in a list of non-tip locations. Paragraph 0020 refers to Alcon's Figures 1 and 2, which are "schematic representation[s] of a thermal imaging or thermal recognition source, surgical operating microscope and surgical instrument in accordance with the invention."7 For the purposes of this discussion, which focuses on the surgical instrument of the claims, the figures are effectively the same. Paragraph 0020, read in context with Alcon's Figure 1 (detail, right, focusing on the instrument), suggests that the hub 34 is co-extensive with the aspiration flow passage 32, which terminates at a suction port 28 in the tip 30, such that the hub must itself be proximal to the tip. The paragraph expressly states that the instrument so described is "conventional". Paragraph 0026 goes further by giving the hub and even the handpiece/driver as examples of what Alcon means by proximal to the tip of the needle 26. Paragraph 0027 offers no further clarification about what may be considered "proximal to the tip". Alcon's specification is ambiguous about what it means by proximal to the tip, but an interpretation of the hub as proximal to the tip is consistent with the specification's disclosure of a conventional instrument. 7 Spec. Â¶0009. Appeal 2011-006283 Application 12/350,294 6 Although Alcon has not made the argument, we observe that case law allows an applicant to rely also on an "original claim" for support. The present application was filed as a continuing application with new claims that include the "hub spaced from the tip" language. We note, however, that the continuing application did not include a new oath; consequently, the new claims were treated as an amendment to the parent application (from which the oath was reproduced).8 We have no basis for believing that the original claims in the parent application included the "spaced from" language.9 Consequently, we find no support for the "spaced from" language in Alcon's specification, much less support that would require exclusion of locations proximal to the tip. In its request for rehearing, Alcon belatedly offers the following dictionary definition and requests that the board take notice of the definition:10 the enlarged base by which a hollow needle may be attached to a device (as a syringe) We reject the notion that we could have erred in failing to apprehend a definition that had not been proffered to us.11 Alternatively, there are several problems with the definition. First, the internet source to which Alcon refers12 does not provide the stated definition. We 8 37 C.F.R. Â§ 1.63(d)(1)(iii). 9 See Ex parte Alcon, Inc., App. No. 2008-1025, slip op. at 2-3 (BPAI, dec'd 17 June 2008) (reproducing a representative claim from the parent application). 10 Reh'g 4; cf. Br. 32 (evidence appendix) (listing no definition). 11 37 C.F.R. Â§ 41.52(a)(1) ("The request for rehearing must state with particularity the points believed to have been misapprehended or overlooked by the Board. Arguments not raised, and Evidence not previously relied uponâ€¦are not permittedâ€¦."). 12 Reh'g 4, citing "http://www2.merriamwebster.com/cgi-bin/mwmedsamp" (producing a blank screen when visited in November 2012). Appeal 2011-006283 Application 12/350,294 7 note, however, the same definition at an apparently related site.13 Second, even if we take notice of the definition, it is not clear how that definition relates to Alcon's invention. Alcon does not point us to any comparable requirement in its claim or disclosure in its specification and we see none. Indeed, Alcon Figures 1 and 2 do not show any enlarged base where figure number 34 points; rather figure number 34 points generally to a section of the needle inside the instrument. Moreover, if we were to take notice of the definition, then we might also take notice of contemporary patents in which the term is used.14 For example, Figure 9 of United States Patent 8,172,808 B215 (detail, left) shows a needle hub 48 that is consistent with the internet definition (an enlarged base for connecting a needle to a syringe). Similarly, United States Patent 8,012,132 B216 (detail, right) shows an optional needle hub 120 consistent with the internet definition (an enlarged base for connecting a needle to 13 http://www.merriam-webster.com/dictionary/hub (under the header "(Medical Dictionary)") (visited November 2012). 14 Cf. In re Chippendales USA, Inc., 622 F.3d 1346, 1356 (Fed. Cir. 2010) (taking sua sponte notice of registered trademarks); In re Cortright, 165 F.3d 1353, 1358 (Fed. Cir. 1999) (taking sua sponte notice of other patents for purposes of claim interpretation). 15 W.T. Torris et al., Tamper evident vacuum tube holder assembly and needle hub assembly therefore, US 8,172,808 B2 (issued 8 May 2012) (from application filed 22 April 2003). 16 C.L. Lum & I. Zivkovic, Luer-snap connection and luer-snap syringe, US 8,012,132 B2 (issued 6 September 2011) (from application filed 24 February 2009). Appeal 2011-006283 Application 12/350,294 8 a syringe). Significantly, neither of these structures resembles Alcon's hub 34 in Figures 1 and 2. If we must choose between disclosures in Alcon's specification and drawings or a conflicting definition, case law compels us to stick with Alcon's disclosure.17 The internet definition, while "medical", does not appear to be directed to the same structure. Although Alcon describes the surgical instrument as "conventional", Alcon did not provide evidence of such conventional instruments to show what "hub" means in this specific context. In sum, while Alcon's hub cannot include the needle tip, Alcon has not quantified what "spaced from" means such that it cannot include locations proximal to the needle tip. Indeed, if anything, the specification requires the hub to be considered proximal to the tip. Our original decision expressly considered a tip- proximal interpretation sufficient for its decision.18 Sensing along the hub is just a proxy for what really matters, determining potential heat risks to tissue. Thus, while the opinion's reference to the needle tip was not proper, the improper reference did not amount to prejudicial error. The examiner has been clear about how and why "along the hub" could not be read as narrowly as Alcon urges. Alcon controlled the drafting of the specification and the claims. Alcon was in the best position to ensure that the specification and claims were consistent with each other and clearly stated what Alcon regards as the invention.19 17 E.g., Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364, 1373 (Fed. Cir. 2001) (explaining that a technical dictionary should not be adopted if it is contrary to the intrinsic evidence). 18 Decision 3-5. 19 35 U.S.C. 112. Appeal 2011-006283 Application 12/350,294 9 ANALOGOUS ART Alcon argues that the board misapprehended the law of analogous art and the disclosures of the Laird patent20 and the Poppas patent.21 Generally Much of Alcon's discussion about the case law turns on very fine distinctions of language.22 Alcon must appreciate, however, that the language of the opinion reflects the procedural posture of the case before the board: the claims stood rejected and Alcon has the burden of persuasion that the examiner has prejudicially erred. While the examiner has the ultimate burden of proof for the rejection, the examiner had already found the Laird and Poppas patents to be analogous. Consequently, the board may reasonably frame the question in terms of whether the examiner's findings amount to reversible error. Such framing in no way changes the applicable test. Alcon also suggests23 that the board misapprehended the policy basis for the analogous art determination in its citation to Wyers v. Master Lock Company.24 The board cited Wyers25 as authority for the following sentence: Case law directs the scope of analogous art be construed broadly so that, whether or not the prior art is in the exact same field of endeavor, those skilled in the art are not denied access to technical know-how that is reasonably pertinent to the problem they face. 20 R.J. Laird et al., Ribbed electrodes and methods for their use, US 6,533,780 (issued 18 March 2003). 21 D.P. Poppas et al., Laser tissue welding control system, U.S. Patent 5,409,481 (issued 25 April 1995). 22 Reh'g 5-8. 23 Reh'g 7-8. 24 616 F.3d 1231 (Fed. Cir. 2010). 25 Decision 10, citing id. at 1238. Appeal 2011-006283 Application 12/350,294 10 No part of the sentence is in quotes so a reader would understand the opinion to be restating the court's discussion. The Wyers court itself, in its discussion of analogous art on the cited page, cites and partially quotes Supreme Court precedent as follows: The Supreme Court's decision in KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007), directs us to construe the scope of analogous art broadly, stating that "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 402, 127 S.Ct. 1727 (emphasis added). The paraphrase in the board opinion is reasonably consistent with the court's discussion of analogous art with reference to the KSR opinion. A misstatement of policy is unlikely in itself to be prejudicial but, in any case, Alcon has not demonstrated a misstatement of policy. Laird Alcon urges that the board misapprehended Laird's teachings when affirming the examiner's reliance on Laird. Specifically, Alcon identifies three putative errors: finding a common need for accurate temperature determination, finding a common goal of avoiding untargeted tissue damage and applying the wrong standard in determining Laird's relevance.26 In the final rejection, the examiner relies on Laird as follows (for most of the claims, including the two independent claims):27 Laird teaches therapeutic heating and cooling of human tissue. These temperature fluctuations will often be verified and/or controlled by sensing the temperature of the target tissue and the adjacent tissue directly. Such temperature sensing may be provided using a needle 26 Reh'g 8. 27 Final Rej. 8. Appeal 2011-006283 Application 12/350,294 11 containing two temperature sensors: one at the tip and a second along the shaft [or hub] of the needle (column 10, lines 39-54). It would have been obvious to one of ordinary skill in the art at the time the invention was made to place at least one secondary temperature sensor in the device and method of Baerveldt along the shaft (or hub) of the needle, as taught by Laird, in order to thereby calculate an accurate temperature at the sensor locations (paragraph 185 of Baerveldt). Alcon argues that Laird does not operate in the same manner as Alcon's disclosed invention and does not produce greater accuracy in temperature monitoring as a consequence.28 Alcon's argument misapprehends the rejection. The examiner relies on Baerveldt29 for the teaching of multiple temperature sensors at different locations to allow a more accurate calculation of the temperature. Laird teaches placement of sensors on different parts of the same needle. The examiner contemplates a combination of the teachings such that Baerveldt's temperature sensing may occur at locations spaced apart on the same needle. Alcon's misapprehension appears to flow from an assumption that all of Laird must be relevant to Alcon's invention. There is no such requirement in the law. An automobile designer faced with a problem of steering an automobile may reasonably be expected to look to a steering wheel or a tiller of a ship, even though automobiles and ships are significantly different in many other regards. The pertinent part, a need to steer, is common to both vehicles. Similarly, once the medical instrument designer has discerned a need for sensing temperature at more than one location, Laird's teaching that at the tip and along the shaft are appropriate locations would be of immediate use. While the manner in which Laird is used differs (as the board opinion acknowledges), the purpose (detecting a spread of 28 Reh'g 8-13. 29 G. Baerveldt & R. Chuck, Minimally invasive glaucoma surgical instrument and method, US 2002/0111608 A1 (pub'd 15 August 2002). Appeal 2011-006283 Application 12/350,294 12 dangerous temperatures to untargeted tissue) is sufficiently the same to make the relevance of the teaching immediately apparent on one of skill in the art. Alcon also argues that one skilled in the art would avoid detecting the temperature of the instrument itself because that would constitute "noise" in the temperature signal.30 No testimony or authority is proffered for this statement of fact. In any case, the argument assumes a narrow interpretation of "along the hub" that neither Alcon's specification nor its claims require. Because, consistent with the specification, the hub, which is spaced apart from the tip, can include locations proximal to the tip and to the treated tissue, the proximal portion of the hub would be a natural second location for temperature sensing to compare against the temperature at the tip. Poppas Alcon urges that Poppas is unrelated to the only problem that the board held the Alcon inventor to have faced: avoiding thermal damage to tissue.31 Alcon's own specification cites the Poppas patent as art related to Alcon's invention.32 Given Alcon's reliance on Poppas in its specification, Alcon's insistence that Poppas is not analogous art is troubling. We give greater weight to Alcon's original position that Poppas is related because that position was adopted before the claims were rejected using Poppas.33 Alcon has not given us any basis that would justify its change of heart. 30 Reh'g 14-15. 31 Reh'g 15-16. 32 Spec. Â¶0002 (first paragraph under the heading "Description of Related Art"), citing "US Patent No. 5,409,481[, which] describes a laser tissue welding control". 33 Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (favoring ante litem motam evidence is reasonable). Appeal 2011-006283 Application 12/350,294 13 In any case, as the board opinion explained, the examiner relied on Poppas to teach an infrared monitoring and control feedback loop.34 Alcon argues that this monitoring and control has not been shown.35 Alcon does not, however, address the findings regarding Poppas on page 9 of the opinion, much less identify a prejudicial error in those findings. As the examiner explained in the final rejection:36 Poppas teaches an alternative infrared detector for determining tissue temperature of an operating area. It is directly applicable to the problem faced by the current application. We see no prejudicial error in the examiner's finding. HOLDING The discussion in the original opinion is modified as explained above, but relief from the decision on appeal isâ€” DENIED For appellant: ROBERT J. HESS, Hess Patent Law Firm, PC, of Stamford, Connecticut. cam 34 Decision 11. 35 Reh'g 15. 36 Final Rej. 6.