Ex Parte MythenDownload PDFPatent Trial and Appeal BoardAug 8, 201411885472 (P.T.A.B. Aug. 8, 2014) 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. 11/885,472 08/31/2007 Michael Mythen 0119/0072 5000 21395 7590 08/08/2014 LOUIS WOO LAW OFFICE OF LOUIS WOO 717 NORTH FAYETTE STREET ALEXANDRIA, VA 22314 EXAMINER STUART, COLIN W ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 08/08/2014 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 MICHAEL MYTHEN __________ Appeal 2012-001297 Application 11/885,472 Technology Center 3700 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an apparatus including a tube and an elongate penetration instrument. The Examiner rejected the claims as indefinite and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 1 Appellant identifies the Real Party in Interest as Smiths Group PLC (see App. Br. 3). Appeal 2012-001297 Application 11/885,472 2 Statement of the Case Background “In various surgical situations it is necessary to make a passage into a body cavity so that a tube can have one end inserted in the cavity” (Spec. 1). The Specification teaches that “where the patient is obese and has an excessive thickness of tissue overlying the trachea, it can be difficult to estimate the thickness of the tissue and conventional tubes with fixed flanges may not be suitable” (Spec. 1). The Specification teaches that often “it is preferable to use a tube with a flange that can be moved . . . . A problem with such tubes is that the flange has to be manipulated and positioned after the tube has been inserted, which can cause trauma to the patient” (Spec. 1). The Claims Claims 1–11 are on appeal. Claims 1, 3, and 10 are representative and read as follows: 1. Apparatus including a tube and an elongate penetration instrument, the instrument being adapted to penetrate a body cavity in which the tube is to be placed, characterized in that the instrument is provided with visible markings along its length by which the extent of insertion of the instrument can be readily ascertained, that the tube is correspondingly provided with visible markings of the same character as those on the instrument, and that the tube has a flange movable and lockable along the length of the tube against the markings so that the flange can be positioned appropriately by observation of the markings on the instrument indicative of extent of penetration. 3. Apparatus according to Claim 1, characterized in that the visible markings are colored differently from one another. Appeal 2012-001297 Application 11/885,472 3 10. A method of placing a tube in a body cavity comprising the steps of: penetrating body tissue with an instrument, detecting when the instrument has penetrated the body cavity, observing markings along the instrument to determine which marking is aligned with the skin surface, displacing a flange along a tube until the flange is aligned with a marking on the tube corresponding to the marking on the instrument, retaining the flange in position on the tube and subsequently inserting the tube along the passage established by the instrument until the flange on the tube comes into contact with the skin surface. The issues A. The Examiner rejected claim 3 under 35 U.S.C. § 112, second paragraph as indefinite (Ans. 4). B. The Examiner rejected claims 1 and 4–11 under 35 U.S.C. § 103(a) as obvious over Toye,2 McNeirney,3 and Christopher4 (Ans. 5–7). C. The Examiner rejected claims 2 and 3 under 35 U.S.C. § 103(a) as obvious over Toye, McNeirney, Christopher, and Clark5 (Ans. 7–8). A. 35 U.S.C. § 112, second paragraph The Examiner finds that, in claim 3, “it is unclear as to what is meant by the limitation ‘the visible markings are colored differently from one another’ (line 2). Is the claim referring to the visible markings on the tube or the instrument?” (Ans. 4). 2 Toye, F., US 4,364,391, issued Dec. 21, 1982. 3 McNeirney, J., US 6,200,274 B1, issued Mar. 13, 2001. 4 Christopher, K., US 5,515,844, issued May 14, 1996. 5 Clark et al., US 6,613,002 B1, issued Sept. 2, 2003. Appeal 2012-001297 Application 11/885,472 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that claim 3 is indefinite? Findings of Fact 1. The Specification teaches that the “needle 10 has visible markings 13 along its length in the form of four, differently coloured bands extending around the circumference of the needle and arranged one after the other” (Spec. 3). 2. The Specification teaches that: The rear, machine end of the tube has a straight portion 25, along which the flange 24 can be positioned, and a part of the length of this portion has visible markings of the same character as those on the needle, in the form of a series of four differently coloured bands 26 located one after the other to provide a pattern of bands of the same colour and arranged in the same order as the bands 13 on the needle 10. (Spec. 4.) Principles of Law A “patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2124 (2014). Analysis In interpreting the phrase “the visible markings are colored differently from one another” in claim 3, several different interpretations are consistent with the claim language. First, each marking may be differently colored on a single device so claim 3 may be interpreted as a set of visible markings Appeal 2012-001297 Application 11/885,472 5 composed of different colored bands on the instrument and the same visible markings and color bands on the tube, as taught by the Specification (FF 1– 2) and argued by Appellant (App. Br. 10). Second, the visible markings on the instrument may be composed of one set of colors which are differently colored than a second set of colors employed as visible markings on the tube. A third interpretation is that the same set of colors is used for both the instrument and tube, but the order of colors is different, such that the “visible markings are colored differently from one another.” Appellant contends that this limitation “is made clear in the specification, with reference to page 3, lines 5-7 (for the visible markings on the instrument), and page 4, lines 9-14 (for the visible markings on the tube)” (App. Br. 10). We are not persuaded. Appellant argues limitations found in the Specification, but we do not read limitations from the Specification into the claims. See SuperGuide Corp. v. DirecTV Enters, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”) The instant situation is one where “the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.” Halliburton Energy Appeal 2012-001297 Application 11/885,472 6 Servs., Inc. v. M–I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). Appellant has not chosen to amend and clarify the claim, but rather simply argue. We therefore affirm the rejection. Conclusion of Law The evidence of record supports the Examiner’s conclusion that claim 3 is indefinite. B. 35 U.S.C. § 103(a) over Toye, McNeirney, and Christopher The Examiner finds that “Toye teaches an elongate penetration instrument (syringe 24, upper body 22, and needle 20) for penetrating a body cavity (e.g. a trachea as shown in Fig. 1) in which a tracheostomy tube (reference 42 in Figs. 4 and 7-10) with a flange (i.e. tube cap portion 44) is to be placed” (Ans. 5). The Examiner acknowledges that “Toye fails to teach that the instrument has visible markings” (Ans. 5). The Examiner finds that “McNeirney teaches that spaced markings along the surface of a surgical insertion needle to indicate the depth of penetration of the tip of the needle is old and well-known” (Ans. 5). The Examiner acknowledges that “Toye in view of McNeirney does not teach that the tube has visible markings and a movable flange” (Ans. 5). The Examiner finds that “Fig. 9 of Christopher teaches a tracheostomy tube (10) with visible markings (shown in Fig. 9) and a flange (neck flange 11) [that is] movable (i.e. adjustable; see column 10, lines 20- 22) and lockable” (Ans. 5). The Examiner finds it obvious to “provide the penetration needle of Toye with spaced markings along its surface as taught by McNeirney in order to allow a physician to keep track of the depth of penetration of the Appeal 2012-001297 Application 11/885,472 7 needle through a patient’s neck” (Ans. 5). The Examiner further finds it obvious to “substitute the tracheostomy tube of Toye with the tracheostomy tube comprising visible markings and a movable and lockable neck flange as taught by Christopher in order allow [sic] a physician greater control over the insertion and placement of a tracheostomy tube” (Ans. 6). The Examiner also finds it obvious [T]o modify the tube and instrument of Toye in view of McNeirney further in view of Christopher to have corresponding markings in order to facilitate proper fitting of the tracheostomy tube into a patient’s trachea based on the observed length of the patient’s tracheotomy stoma and to prevent the need for making marking length conversions. (Ans. 6.) The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Toye, McNeirney, and Christopher render the claims obvious? Findings of Fact 3. Toye teaches that a “hollow inner needle 20, similarly wedge- shaped at its distal end, is coaxially slidably received within the outer needle bore 18 and is characterized by an upper body 22 which is engageable upon the outer needle upper body 12” (Toye, col. 4, ll. 1–5). Appeal 2012-001297 Application 11/885,472 8 4. Figures 1 and 4 of Toye are reproduced below: “FIG. 1 is an elevational view of the inner and outer needles of the present tracheostomy apparatus, a syringe being utilized to facilitate initial insertion of the needles into the tracheal lumen . . . . FIG. 4 is a view . . . illustrating threading of the dilator leader into the outer needle slot” (Toye, col. 2, ll. 29–42). 5. Toye teaches that a “complementally [sic, complementarily] curved metal trachea tube 42 is coaxially slidably fitted over the curved intermediate portion 34 of the dilator 30 . . . . The upper or proximal end of the trachea tube 42 includes a flat cap portion 44 which engages the shoulder” (Toye, col. 4, ll. 50–63). Appeal 2012-001297 Application 11/885,472 9 6. McNeirney teaches that: Needles are commonly employed to obtain biopsy specimens for laboratory evaluation. This entails a surgical procedure which requires that the surgeon know precisely the depth to which the needle is inserted in the patient’s tissue to be sure that a proper specimen is obtained. Typically, spaced markings are provided along the surface of the needle to indicate the depth of penetration of its tip. A depth stop may be employed to limit penetration of the needle to the desired depth. (McNeirney, col. 1, ll. 19–26.) 7. Figure 9 of Christopher is reproduced below: Figure 9 shows that “an adjustable neck flange 11 slides relative to the tracheostomy tube 10 and can be manually positioned at any desired location along its length” (Christopher, col. 10, ll. 40–42). Appeal 2012-001297 Application 11/885,472 10 8. Christopher teaches that [A] series of radio-opaque markings extend along the length of the tracheostomy tube 10. These markings permit the health care provider to visually check whether the neck flange 11 has moved from its desired position on the tracheostomy tube. The markings also permit the health care provider to clearly observe the position of the distal end 15 of the tracheostomy tube 10 within the patient’s trachea by means of x-ray imaging. (Christopher, col. 10, ll. 46–53.) Analysis Claim 1 Toye teaches an apparatus which comprises a tracheostomy tube (“curved metal trachea tube” (FF 5)) and an elongate penetration instrument (“inner and outer needles” (FF 4)). Toye teaches that the device is for insertion into the trachea, a body cavity (FF 3–5). Toye does not teach visible markings or flanges on the tube (see Ans. 5). McNeirney teaches the use of visible markings on needles where “spaced markings are provided along the surface of the needle to indicate the depth of penetration of its tip” (McNeirney, col. 1, ll. 24–25; FF 6). Christopher teaches flanges on tracheostomy tubes, specifically teaching that “an adjustable neck flange 11 slides relative to the tracheostomy tube 10 and can be manually positioned at any desired location along its length” (Christopher, col. 10, ll. 40–42; FF 7). Christopher also teaches visible markings on tracheostomy tubes, teaching that “markings permit the health care provider to visually check whether the neck flange 11 Appeal 2012-001297 Application 11/885,472 11 has moved from its desired position on the tracheostomy tube” (Christopher, col. 10, ll. 48–50; FF 8). Applying the KSR standard of obviousness to the findings of fact, we conclude that the person of ordinary skill would have reasonably marked Toye’s needles since McNeirney teaches that spaced markings allow indications on the depth penetration of the needle (FF 6). Further, we conclude that the person of ordinary skill would have incorporated a movable flange into Toye’s tracheostomy tube to permit manual positioning of the flange along the tube as taught by Christopher (FF 7). The ordinary artisan would also have put markings on Toye’s tracheostomy tube to ensure that the tube is placed in the desired position (FF 8). Adding visible markings and a flange as expressly suggested by the prior art (FF 6–8) is merely a “predictable use of prior art elements according to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Appellant contends that “[n]one of Toye, McNeirney and Christopher discloses visible markings at an instrument used to penetrate the patient and corresponding visible markings at a tube that guide the positioning of a movable flange along the tube by referencing the visible markings at the instrument” (App. Br. 11). Appellant contends that “there is no teaching or suggestion in any of those references that the flange of the tube is to be moved against the markings on the tube by observing the markings on the penetrating instrument” (App. Br. 13). We do not find this argument persuasive for the apparatus claims, whose structural limitations only require visible markings on both the penetration instrument and tube. The requirement that “the tube is Appeal 2012-001297 Application 11/885,472 12 correspondingly provided with visible markings of the same character as those on the instrument” (claim 1) merely requires markings that allow “the flange [to] be positioned appropriately by observation of the markings” (Claim 1). This limitation requires only that the markings allow the position of a flange on the instrument to be observed, a function that is allowed by the markings on the devices of McNeirney and Christopher (see FF 6, FF 7). Claim 10 Appellant contends that “claim 10 requires the step of ‘observing markings along the instrument to determine which marking is aligned with the skin surface’, and the step of ‘displacing a flange along a tube until the flange is aligned with a marking on the tube corresponding to the marking on the instrument’” (App. Br. 14). The Examiner finds that: While the references may not explicitly describe aligning markings with the skin surface, the visible markings along the instrument of the modified Toye reference are used to determine depth of the instrument and one of ordinary skill in the art would recognize to observe the marking aligned with the skin surface when determining the depth of the instrument to correspondingly adjust the flange position on the tube and therefore the depth of the tube. (Ans. 12.) We find that Appellant has the better position. Unlike apparatus claim 1, claim 10 is a method claim. As Appellant correctly notes, claim 10 requires that the “flange is aligned with a marking on the tube corresponding to the marking on the instrument.” Thus, it is not sufficient for a rejection of claim 10 to simply demonstrate the obviousness of an apparatus with Appeal 2012-001297 Application 11/885,472 13 markings on both the instrument and the tube, as for claim 1. Instead, there must also be a reason, supported by evidence, to align the markings on the instrument and the marking on the tube as required by claim 10. The Examiner may provide a reason to align the flange with the tracheostomy tube (see Ans. 6, 12), but the Examiner has not explained why it would have been necessary to further align these elements with the penetration device or needle. Conclusion of Law The evidence of record supports the Examiner’s conclusion that Toye, McNeirney, and Christopher renders claim 1 obvious. The evidence of record does not support the Examiner’s conclusion that Toye, McNeirney, and Christopher renders claims 10 and 11 obvious. C. 35 U.S.C. § 103(a) over Toye, McNeirney, Christopher, and Clark Appellant contends, regarding Clark, that [E]ven ignoring for the moment that the marks are radiopaque marks that are visible under imaging, not visually as required in the claims, such regular interval marks would not provide an accurate determination of the extent of insertion of the instrument into the patient as the instrument may well be inserted into the patient between markings. (App. Br. 15.) The Examiner finds that the “Clark reference was used for the teaching of medical instruments with visible markings in the form of bands of different colors (see Clark col. 1 ln. 19-20) to provide better visibility to the visible markings” (Ans. 12–13). Appeal 2012-001297 Application 11/885,472 14 We find that the Examiner has the better position. Clark teaches that “the placement of a series of markings on a surgical instrument such as a . . . catheter, needle, etc., can aid the physician in proper placement of the device in the body of a patient during a medical procedure. These markings can include . . . colors . . . to indicate position or movement of the device within the body” (Clark, col. 1, ll. 15–22). We agree with the Examiner that Clark reasonably suggests the use of color as a type of visible marking on a needle or catheter (i.e., tube for insertion into patient), where incorporation of Clark’s color as a marking into the apparatus of Toye, McNeirney, and Christopher is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. To the extent that Appellant is pointing to the specific embodiment taught by Clark, the “test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . . Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). SUMMARY In summary, we affirm the rejection of claim 3 under 35 U.S.C. § 112, second paragraph as indefinite. We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Toye, McNeirney, and Christopher. Pursuant to 37 C.F.R. § 41.37(c)(1)(iv), we also affirm the rejection of claims 4–9, as these claims were not argued separately. Appeal 2012-001297 Application 11/885,472 15 We reverse the rejection of claims 10 and 11 under 35 U.S.C. § 103(a) as obvious over Toye, McNeirney, and Christopher. We affirm the rejection of claims 2 and 3 under 35 U.S.C. § 103(a) as obvious over Toye, McNeirney, Christopher, and Clark. 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 cdc Copy with citationCopy as parenthetical citation