Ex Parte McCary

Patent Trials and Appeals BoardJun 12, 2019

14513459 - (D) (P.T.A.B. Jun. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/513,459 10/14/2014 23702 7590 06/14/2019 Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 FIRST NAMED INVENTOR Brian D. McCary 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. P05725 (6639-000558-US) 1754 EXAMINER FARRAR, LAUREN PENG ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 06/14/2019 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): patents@bausch.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRIAND. MCCARY 1 Appeal2018-007967 Application 14/513,459 Technology Center 3700 Before MICHAEL L. HOELTER, WILLIAM A. CAPP, and JEFFREY A. STEPHENS, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. Â§ 134(a), from the Examiner's final rejection of claims 1-8, 17, 18, and 20-24, which constitute all the claims pending in this application. App. Br. 2. Claims 9- 16 and 19 have been canceled. App. Br. 2. We have jurisdiction under 35 U.S.C. Â§ 6(b ). For the reasons explained below, we AFFIRM the Examiner's rejection of claims 1-8, 17, 18, and 20-24 under 35 U.S.C. Â§ 103. 1 "The real party in interest in the present case is Bausch & Lomb Incorporated." App. Br. 2. Accordingly, we proceed on the basis that, for the purposes of this appeal, Bausch & Lomb Incorporated is the "Appellant." Appeal2018-007967 Application 14/513,459 CLAIMED SUBJECT MATTER The disclosed subject matter "relates to ophthalmic ultrasonic handpieces that include aspiration of dissected tissue." Spec. ,r 1. Apparatus claims 1 and 17 are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. A needle for use with an ultrasonic handpiece for dissecting and aspirating vitreous tissue, the needle comprising: a cannula having a lumen extending from a port adjacent a cannula distal tip to a cannula proximal end; wherein the cannula port has a cross-sectional area less than a cross-sectional area of the cannula lumen; a hub attached to the cannula proximal end, the hub including structure for attachment to the ultrasonic handpiece; wherein the hub includes a lumen extending through the hub, the hub lumen being coaxial and in communication with the cannula lumen, such that a water column is formed from the cannula port to a point at which an aspiration path is significantly larger than the cannula lumen; and wherein a length of the water column is approximately an odd quarter of a drive frequency wavelength of the ultrasonic handpiece and a cannula length measured from the cannula distal tip to a distal end of the hub is long enough to extend from an incision site across a posterior segment of an eye. REFERENCES RELIED ON BY THE EXAMINER Wuchinich US 4,425,115 Jan. 10, 1984 Spinosa et al. US 4,634,420 Jan. 6, 1987 Stulen et al. US 2009/0143796 Al June 4, 2009 THE REJECTION ON APPEAL Claims 1-8, 17, 18, and 20-24 are rejected under 35 U.S.C. Â§ 103 as unpatentable over Spinosa, Stulen, and Wuchinich. 2 2 The Examiner mistakenly references claims 1-24 when, in fact, claims 9- 16 and 19 have been canceled. See Amendment dated June 14, 201 7. 2 Appeal2018-007967 Application 14/513,459 ANALYSIS Appellant presents separate arguments for claim 1 and for claim 1 7. See App. Br. 3---6. Appellant contends that the remaining dependent claims should be allowable in view of the arguments presented for claims 1 and 17. See App. Br. 5, 6. We select independent claims 1 and 17 for review, with the remaining claims (i.e., claims 2-8, 18, and 20-24) standing or falling with their respectively selected independent claim 1 or 17. See also 37 C.F.R. Â§ 4I.37(c)(l)(iv). Claim 1 The Examiner primarily relies on the teachings of Spinosa for disclosing the limitations of claim 1. See Final Act. 2 (referencing Spinosa 6:40-51 and Figs. 1, 4). However, the Examiner acknowledges that "Spinosa does not explicitly disclose the length of the needle is approximately an odd quarter of a drive frequency of the ultrasonic handpiece." Final Act. 2; see also Ans. 2. The Examiner relies on Stulen for this disclosure and provides a reason for the combination of Spinosa with the teachings of Stulen. See Final Act. 3 (referencing Stulen ,r 83 and Fig. 4). The Examiner further acknowledges that "Spinosa/Stulen do not teach the aspiration path is significantly larger than the cannula lumen." Final Act. 3. The Examiner relies on Wuchinich for such teachings, and again provides a reason for combining "the device of Spinosa/Stulen with" the teachings of Wuchinich. See Final Act. 3 (referencing Wuchinich 6:49- 66, 8:21-39, and Fig. 2); see also Ans. 3. Appellant addresses that portion of Spinosa identified by the Examiner (i.e., Spinosa 6:40-51) stating, "[t]he cited section has nothing to do with the claimed cannula length let alone that the length is sufficient to 3 Appeal2018-007967 Application 14/513,459 extend from an incision site across a posterior segment of the eye." 3 App. Br. 3--4: see also Reply Br. 1. The section of Spinosa in question states, "the present invention, a highly effective vibratory needle and treatment fluid sheath means[,] can be provided in which treatment fluid can be supplied to the area of operation" in a manner that will not "cause collapse of the eye structure, whether it be the anterior or posterior section of the eye." Spinosa 6:40--47. Spinosa further states, "the present invention provides the treatment fluid at the area of operation" so as to not hinder the removal of "fragments which must be aspirated from the eye." Spinosa 6:47-51. Appellant proceeds to focus on other sections of Spinosa, both immediately before and immediately after the above-referenced section. See App. Br. 4 (referencing Spinosa 6:37-39 and 6:52-57). Based on these alternate sections, Appellant argues that "Spinosa is directed toward a cataract removal system, i.e. an anterior segment device ... not the claimed posterior segment." App. Br. 4. Thus, "[t]here is no teaching or suggestion in Spinosa to meet this claim limitation" of the cannula length being "long enough to extend ... across a posterior segment of an eye." App. Br. 4--5. As indicated above, Appellant does not address the specific disclosure in Spinosa, referenced by the Examiner, which discusses a desire, by Spinosa, to employ a needle in a manner that will not "cause collapse of the ... posterior section of the eye." See supra. In view of such teachings, Appellant's contention that Spinosa's needle has insufficient length to reach this section of the eye, is not persuasive. 3 Appellant further argues, "Spinosa is silent regarding the length of the needles and vague, non-specific references to posterior use are insufficient to support the Examiner's position." Reply Br. 2. 4 Appeal2018-007967 Application 14/513,459 Further, the limitation in question recites a length "long enough to extend from an incision site across a posterior segment of an eye." Emphasis added. Spinosa only expressly discloses treatment "to" or "at" an area of operation (Spinosa 6:42--43; 6:48), not "across" it as recited. However, there is no indication by Appellant that every patient's eye has the same depth and/or geometry, and thus, there is no indication by Appellant that Spinosa's device would not be able to extend "across a posterior segment" of a patient having a differently-shaped eye. Consequently, Appellant's arguments are not persuasive that one skilled in the art, reviewing Spinosa's teachings, would fail to understand that Spinosa's needle would be inserted as far as is needed, whether "to," "at," or "across" the posterior segment of the eye. See, e.g., Reply Br. 1-2. Appellant next addresses the recited "water column," stating that "none of the cited art" teaches its recited length. 4 App. Br. 4; see also Reply Br. 2. Appellant acknowledges that, at best, "the cited art teaches a needle length that is an odd quarter of a drive frequency, though the exact measuring end points are not clear." App. Br. 4. In other words, the "cited art" does not make clear "if the cited needle length includes the attachment hub structure or only includes a cannula length beyond the hub." 5 App. Br. 4. 4 Claim 1 states, "wherein a length of the water column is approximately an odd quarter of a drive frequency wavelength of the ultrasonic handpiece." 5 Appellant further alleges, "[t]here is no way of knowing where or if Spinosa has the claimed point where the aspiration path is significantly larger than the cannula lumen," a location used in ascertaining the length of the water column. Reply Br. 2. However, as indicated above, the Examiner relies on the combination with Wuchinich, not Spinosa alone, for teaching 5 Appeal2018-007967 Application 14/513,459 Such a lack of clarification in the cited art is not persuasive because Appellant presents embodiments that incorporate both situations (i.e., excluding the hub length (see Spec. ,r,r 17, 19 and, respectively, Figs. 2, 4) as well as including the hub length (see Spec. ,r 18 and Fig. 3)). See also Reply Br. 2. Further, the claim language in question recites the water column as having a length that is "approximately" a certain value. 6 Appellant does not explain how either situation identified above (i.e., including or excluding hub length) alters the Examiner's water column length to such a degree that this term ("approximately") is no longer applicable. 7 Appellant further contends that claim 1 is directed to a "water column length" whereas, "[i]n contrast, the Examiner consistently refers to needle lengths and Stulen' s teachings are directed to needle lengths, not the claimed water column lengths." App. Br. 4. Stulen actually refers to an "end effector" length (Stulen ,r 83), and the Examiner relies on Spinosa (not Stulen) for disclosing both a "water column" and "a length of the needle" being "long enough." Final Act. 2. As expressed by the Examiner, a skilled person would have found it obvious "to modify the device of Spinosa with the specific length as taught by Stulen." Final Act. 3 (referencing Stulen ,r 11 ). Thus, it is not quite clear what the basis is of Appellant's contention since the Examiner is relying on the combination of Spinosa and Stulen for the limitation of an "aspiration path that is significantly larger." Final Act. 3; Ans. 3. 6 The Examiner states, "[t]he needle/cannula and in tum water column of Spinosa could therefore be modified to have a length that is [the recited distance] as taught by Stulen." Ans. 3. 7 The Examiner states, "it appears the water column is essentially the same as the cannula lumen." Ans. 2; see also Ans. 4. 6 Appeal2018-007967 Application 14/513,459 disclosing the limitation pertaining to "a length of the water column is approximately" a certain value (see above), not Stulen alone. Further, the Examiner is relying on Spinosa, not Stulen, for disclosing the limitation pertaining to "a cannula length [being] long enough to extend from an incision site across a posterior segment of an eye."8 Final Act. 2. Appellant also broadens the contention regarding the recited water column length stating "[ n Jone of the cited prior art teaches or suggests such a water column length." App. Br. 5. This contention is not persuasive for the reasons explained above. Appellant further contends that "Stulen does not teach or suggest aspiration" (App. Br. 5; see also Reply Br. 2) and that "Stulen is incapable of having a water column" (Reply Br. 2). Appellant's contentions are not persuasive in view of the fact that the Examiner relied on Spinosa (not Stulen) for disclosing aspiration involving a water column. See Final Act. 2; Spinosa 6:32-39 (addressing the supply of treatment fluid and the removal 8 Regarding Appellant's reference to the Examiner's usage of "needle lengths," the exact language employed by the Examiner when discussing Spinosa is that this reference teaches "a length of the needle is long enough to extend from an incision" into the eye as recited. Final Act. 2. We do not find the Examiner's usage of "needle" in this instance as a cause of confusion, as implied by Appellant. This is because a skilled person would understand that the Examiner's reference to "needle," in this context, is to that portion of Spinosa' s device that would pass through the incision. This understanding is also consistent with the language in claim 1 defining a "cannula length" as not being the entire length of the cannula, but instead only being that portion "measured from the cannula distal tip to a distal end of the hub" (i.e., that portion extending beyond the hub). Claim 1 recites that it is this "cannula length" that is "long enough," same as for Spinosa's needle. 7 Appeal2018-007967 Application 14/513,459 of such fluid "along with reduced tissue mass"). As expressed above, Stulen was relied upon for disclosing an end effector having the recited length, i.e., "an odd quarter of a drive frequency wavelength of the ultrasonic handpiece." Final Act. 3; see also Reply Br. 3 where Appellant replicates another section of Stulen (Stulen ,r 84) that buttresses the Examiner's reliance on Paragraph 83 of Stulen as disclosing this "odd quarter" length limitation. Appellant additionally contends that Stulen does not teach or suggest an end effector length being "long enough to extend across a posterior segment, as claimed." App. Br. 5; see also Reply Br. 2. As noted above, the Examiner relied on Spinosa, not Stulen, for disclosing a length being "long enough to extend" as needed. Final Act. 2. Appellant further contends, "[t]he presently claimed cannula 30 lengths by definition will be shorter than the water column lengths as shown at FIGs. 1--4 and explained in paragraphs 14--19." App. Br. 5. Spinosa discloses a conduit 60 extending through needle 12, including extending into/through hub 56, to where it meets connecting conduit 59. Spinosa 10:29-33, Fig. 1. Thus, the portion of Spinosa's needle inserted into the eye (corresponding to Appellant's cannula length 30) will, likewise, be shorter than the entirety of conduit 60 which, like Appellant's water column, is longer as it also extends into/through hub 56. Appellant also contends that the Examiner's combination of Spinosa, Stulen, and Wuchinich do not meet the limitations of claim 1 "because none of the prior art teach the desirability of a water column of a particular length as claimed." Reply Br. 3. This argument is not persuasive for the reasons previously expressed. Further, Appellant does not indicate how or why the 8 Appeal2018-007967 Application 14/513,459 Examiner's stated reasons (i.e., "desirability") for the above combination (see Final Act. 3) might be in error. Accordingly, and based on the record presented, we are not persuaded the Examiner erred in rejecting claims 1-8 as being obvious over Spinosa, Stulen, and Wuchinich. Claim 17 Appellant relies on the same "water column length," "cannula length," and "long enough" arguments for claim 17 as discussed above regarding claim 1. See App. Br. 5, 6. These arguments are not persuasive for the reasons already expressed. Appellant also contends that, with respect to claim 17, "[t]he cannula, as shown in FIG. 4 is directly attached to the handpiece without an attachment structure such as a hub." App. Br. 6. Granted, claim 17 does not recite a "hub," as does claim 1. 9 Instead, claim 17 recites, "the cannula for attachment to a distal end of the ultrasonic handpiece." The Examiner responds stating that Appellant's "directly attached" language "is not recited in claim 17 ." Ans. 4. There is merit to the Examiner's response because claim 17 is silent as to how the cannula is to be attached, reciting only a cannula "for attachment to" the handpiece. This "for attachment to" language does not preclude the use of a hub in accomplishing this task. See Reply Br. 3. Hence, Appellant's argument directed to a limitation not found in claim 17 (i.e., "directly attached"), is not persuasive of Examiner error. 9 Appellant states, "[ c ]laim 17 claims a cannula alone without claiming a hub, as in claim 1." Reply Br. 3. 9 Appeal2018-007967 Application 14/513,459 Accordingly, and based on the record presented, we are not persuaded the Examiner erred in rejecting claims 17, 18, and 20-24 as being obvious over Spinosa, Stulen, and Wuchinich. DECISION The Examiner's rejection of claims 1-8, 17, 18, and 20-24 as being obvious 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 10