Ex Parte Burbank et alDownload PDFPatent Trial and Appeal BoardNov 21, 201714143738 (P.T.A.B. Nov. 21, 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. 14/143,738 12/30/2013 Fred H. Burbank 297-PDD-10-154 USCON2CON 1024 96000 7590 11/24/2017 C R RarH Tnr/RRS EXAMINER Intellectual Property Department 1415 W. 3rd St. EISEMAN, ADAM JARED Tempe, AZ 85281 ART UNIT PAPER NUMBER 3736 NOTIFICATION DATE DELIVERY MODE 11/24/2017 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): raust@ austiplaw.com B B S IP. Docket @ crbard .com Charles .Runyan @ crbard. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FRED H. BURBANK, MICHAEL L. JONES, FRANK LOUW, and PAUL LUBOCK1 Appeal 2016-003215 Application 14/143,738 Technology Center 3700 Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and WILLIAM A. CAPP, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL 1 According to Appellants, the real party in interest is SenoRx, Inc. See Appeal Br. 3. Appeal 2016-003215 Application 14/143,738 STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1 and 19-37.2 App. Br. 5. Claims 2-18 have been canceled. App. Br. 5; Reply Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. THE CLAIMED SUBJECT MATTER The disclosed subject matter “relates generally to the introduction of filler or marker material into a patient's body, and particularly to the filling a biopsy site within a patient's body from which a biopsy specimen has been taken with a mass of marker material.” Spec. ^ 2. Claims 1, 29, and 33 are independent. App. Br. 40-42 (Claims App’x). Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A system for at least partially filling and marking a cavity within a patient, comprising: a delivery device; a quantity of marker forming fluid located within the delivery device, the quantity of marker forming fluid configured to at least partially fill the cavity and form therein a bioabsorbable body after delivery into the cavity from the delivery device; and a radiopaque marker separate from the quantity of marker forming fluid and releasably attached to a portion of the delivery device, the radiopaque marker configured to be delivered into the quantity of marker forming fluid in the cavity from the delivery device and configured to remain in the 2 Claims 19 and 34 are objected to by the Examiner. Ans. 7. Claim 20 depends from claim 19 and, while the Examiner does not mention it, it is presumed that claim 20 is likewise objected to, and would further be allowable if rewritten to include all the limitations of the base claim and any intervening claim. 2 Appeal 2016-003215 Application 14/143,738 bioabsorbable body upon the formation of the bioabsorbable body in the cavity. REFERENCES Burbank Sirimanne Lubock Mandrusov US 6,161,034 US 6,356,782 B1 US 2003/0233101 A1 US 2004/0002650 A1 Dec. 12, 2000 Mar. 12, 2002 Dec. 18, 2003 Jan. 1, 2004 REJECTIONS Claims 1, 24, 25, 27-29, 33, 35, and 36 are rejected under 35 U.S.C. § 103(a) as unpatentable over Burbank and Sirimanne. Claims 21 and 30 are rejected under 35 U.S.C. § 103(a) as unpatentable over Burbank, Sirimanne, and Lubock. Claims 22, 23, 26, 31, 32, and 37 are rejected under 35 U.S.C. § 103(a) as unpatentable over Burbank, Sirimanne, and Mandrusov. Appellants present separate arguments for claim 1 (App. Br. 16-20) and claim 29 (App. Br. 21-23). Regarding claims 24, 25, 27, 28, 33, 35, and 36, Appellants rely on arguments previously made regarding claims 1 and/or 29. App. Br. 21, 23, and 24. We select claims 1 and 29 for review, with the remaining claims standing or falling therewith. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 1 The Examiner primarily relies on the teachings of Burbank for disclosing the limitations of claim 1, but relies on Sirimanne for teaching the placement of a radiopaque metallic marker suspended in a material within a ANALYSIS The rejection of claims 1, 24, 25, 27—29, 33, 35, and 36 as unpatentable over Burbank and Sirimanne 3 Appeal 2016-003215 Application 14/143,738 patient’s body so that it can be imaged. Final Act. 4 (referencing Sirimanne 11:22 — 12:35).3 The Examiner finds that it would have been obvious “to place a detectable radiopaque metallic marker in the formed precipitate of [] Burbank as taught by Sirimanne in order to provide an easy to see radiopaque metallic marker in the suspension.” Final Act. 4. Appellants initially contend that the cited combination of Burbank and Sirimanne “disclose a unitary marker” and that “the unitary marker is inserted into a delivery lumen for delivery as a unit into the cavity.” App. Br. 17; see also Reply Br. 5. This argument is not persuasive for at least Sirimanne’s Figures 4J through 4L which illustrate a two-part operation wherein body material 418 is placed “into the cavity (404) prior to the placement of the marker (410)” after which “Fig. 4L details the placement of the marker (410) into the body material (418).” Sirimanne 12:24-35; see also Sirimanne 4:35^40. Hence, these Figures do not disclose a “unitary marker” nor the delivery of such marker “as a unit into the cavity” as Appellants’ assert. App. Br. 17; see also Reply Br. 5. Appellants also contend, “there is no reason to replace the radiopaque material in the suspending fluid already disclosed in Burbank ’034 with a different radiopaque material disclosed by Sirimanne.” App. Br. 18; Reply Br. 6. In other words, as per Appellants, “the Sirimanne reference is cumulative as to Burbank ’034” and that “Sirimanne provides nothing not already disclosed in Burbank ’034.” App. Br. 18; Reply Br. 6. We disagree. Although Burbank discloses the use of radiopaque metal ions 10 mixed 3 It is noted that the portions of Sirimanne relied on by the Examiner (i.e., Sirimanne 11:22 to 12:35) encompass descriptions of Sirimanne Figures 4A through 4L. 4 Appeal 2016-003215 Application 14/143,738 within the matrix inserted into the body cavity (see Burbank 8:39 42), Sirimanne goes one step further teaching the insertion of one or more discrete, stand-alone markers into the radiopaque mix. See Sirimanne Figs. 1—4; Sirimanne 4:40^45 (“[t]he gel may also be made radiopaque or echogenic by the addition of radiopaque materials” (such as powdered components) “to the gel”). Hence, contrary to Appellants’ assertions, the Sirimanne reference is not cumulative to Burbank because Sirimanne discloses more than just inserting radiopaque filler material into the cavity as taught by Burbank, but also the addition of one or more discrete, separately distinguishable markers (see Sirimanne Fig. 2) that enables “one to determine the location, orientation, and periphery of the cavity.” Sirimanne 1:12-13; see also Sirimanne 4:16-20. The Examiner’s stated reason to combine Burbank and Sirimanne is that it would have been obvious “to place a detectable radiopaque metallic marker in the formed precipitate of [] Burbank as taught by Sirimanne in order to provide an easy to see radiopaque metallic marker in the suspension.” Final Act. 4. Consequently, Appellants’ assertion that a skilled person “would not have replaced one with the other except through hindsight” is not persuasive that the Examiner erred in combining Burbank and Sirimanne. Reply Br. 6. Appellants further contend that with respect to Burbank, “it would not be reasonable to say that the radiographically visible material within the supporting fluid ... is somehow attached to a portion of the delivery device, because there is no fastening or joining of the radiographically visible 5 Appeal 2016-003215 Application 14/143,738 material to the delivery tube.”4 App. Br. 18; see also Reply Br. 7. The Examiner “contends the marker is releasably attached to the delivery device (it is stuck to the delivery device until it is released and detached from the device and disposed in the body).” Ans. 8; see also Ans. 9. The Examiner’s statement is persuasive. Furthermore, Appellants’ contention is not persuasive in view of Figure 4 of Burbank illustrating the radiographically visible material within Burbank’s supporting fluid that is constrained by Burbank’s delivery device.5 In short, Appellants’ argument that being constrained by the delivery device is not “somehow attached,” fastened, or joined to the delivery device is not persuasive. Regarding the teachings of Sirimanne, Appellants make a similar argument (i.e., “it would not be reasonable to say that [Sirimanne’s] marker within the supporting body ... is somehow attached to a portion of the delivery device” because of the lack of “fastening or joining” of the “marker to the delivery tube”). App. Br. 18-19; see also Reply Br. 7-9. Appellants provide support for this assertion by referencing “Sirimanne Figs. 4A-4C.” App. Br. 19; Reply Br. 9. However, Appellants do not explain how the separate marker 410 of Sirimanne is not “somehow attached” to Sirimanne’s delivery device 400 as depicted in, e.g., Figure 4F. Appellants also address the limitation “the radiopaque marker configured to be delivered into the quantity of marker forming fluid in the 4 According to Appellants, the “common and ordinary meaning of the term ‘attach’ is ‘to fasten or join one thing to another.’ (Merriam-Webster On- Fine Dictionary; emphasis in original).” App. Br. 18; Reply Br. 10. 5 Burbank states, “FIG. 4 is a longitudinal sectional view of an injector device that is useable to introduce a solid (e.g., powdered, particulate organular) marker substance of the present invention into a biopsy site.” Burbank 7:4-7. 6 Appeal 2016-003215 Application 14/143,738 cavity from the delivery device” contending that this limitation is not disclosed in either reference. App. Br. 19. However, Sirimanne clearly teaches “the act of filling the biopsy cavity with a bioabsorbable liquid,” and thereafter “allowing the material to partially solidify or gel and then placing a marker, which may have a configuration as described above, into the center of the bioabsorbable material.” Sirimanne 4:35^40; see also Sirimanne 12:29-35. Hence, Appellants’ contention that Sirimanne fails to first disclose delivering material into the cavity, and then delivering a radiopaque marker into that material in the cavity is not persuasive. Appellants further address the limitation of the recited marker “that is both ‘separate from the quantity of marker forming fluid’ and ‘releasably attached to a portion of the delivery device.’” App. Br. 19; see also Reply Br. 7-9. Appellants’ arguments that the cited combination does not disclose such limitations are not persuasive for reasons previously addressed, and particularly in view of Sirimanne’s Figures 4J to 4L, which illustrate the initial delivery of body material 418 into a cavity after which separate marker 410 is inserted into this body material 418 from delivery device 400.6 Claim 29 Independent claim 29 also recites a separate, releasably attached, radiopaque marker and further one that is “configured to be delivered into the” marker fluid in the patient cavity “prior to the formation of the bioabsorbable body in the breast biopsy cavity.” Appellants contend that 6 Appellants are technically correct in asserting that Sirimanne “does not disclose first delivering a radiopaque marker and then a bioabsorbable supporting material” (Reply Br. 9) since Sirimanne discloses just the opposite procedure. 7 Appeal 2016-003215 Application 14/143,738 this “prior to the formation” language is not taught by the combination of Burbank and Sirimanne. App. Br. 21-22. The Examiner “contends that until the bioabsorbable body is fully formed and set, it is still in the ‘formation’ stage.” Ans. 9. Appellants’ contention is not persuasive because Sirimanne clearly teaches, “allowing the material to partially solidify or gel” after being inserted into a body cavity, “and then [while still not fully formed] placing a marker” therein. Sirimanne 4:35-40. Appellants do not explain how Sirimanne’s disclosure of allowing the previously filled material to “partially solidify or gel” before “placing a marker” therein fails to teach this limitation. See also Ans. 9. Accordingly, and based on the record presented, we are not persuaded that the Examiner erred in relying on the teachings of Burbank and Sirimanne as disclosing the limitations of claims 1 and 29. We sustain this rejection, and further, the Examiner’s rejection of claims 24, 25, 27, 28, 33, 35, and 36. The rejection of claims 21 and 30 as unpatentable over Burbank, Sirimanne, and Lubock Appellants argue claims 21 and 30 separately, but present similar arguments for each. App. Br. 24-29. We address claims 21 and 30 together. Claims 21 and 30 both depend directly from an independent claim (i.e., claims 1 and 29, respectively) and include the additional limitation, “wherein the radiopaque marker is releasably attached to an external surface of the delivery device.” The Examiner relies on the additional teachings of Lubock for this and references Lubock’s Figures 2C, 2G, and 2H and particularly elements 26 and 54 shown therein. Final Act. 5. Lubock teaches “a plug 26 having a lip portion 54 and a body portion 58 configured 8 Appeal 2016-003215 Application 14/143,738 to press against a tube wall 46 so as to retain plug 26 within the delivery tube 14.” Lubock 45. Appellants address this teaching stating, “plug 26 is held by the expansive force exerted by the body 58 on the tube wall 46” and that “lip portion 54 is optional.” App. Br. 26-27. Thus, “Lubock clearly discloses that it is the plug itself that holds the plug in place by directly pressing against an internal surface of the delivery tube 14.” App. Br. 27. Appellants, in effect, deny any affect lip portion 54 may have on the external surface of tube and contend, “the lip portion being in ‘contact’ with an external surface does not satisfy the respective claim limitation of claim 21.” App. Br. 27. Claims 21 and 30 both employ the word “attached.” which Appellants earlier defined as meaning “to fasten or join one thing to another.” App. Br. 18; Reply Br. 10 (both referencing “Merriam-Webster On-Line Dictionary; emphasis in original”). As indicated above, Lubock describes a plug having both a lip and a body portion “configured to press against a tube wall,” and further, Lubock teaches that lip 54 is “effective to limit the extent of insertion of plug 26 into delivery tube 14.” Lubock 42. Hence, Appellants intentionally disregard the stated function and purpose of lip 54 bearing against the external surface of tube 14 by contending that such lip has no role in fastening or joining the plug to the tube. App. Br. 26-29. Such argument is not persuasive in view of the above express teachings regarding Lubock’s lip 54. We sustain the Examiner’s rejection of claims 21 and 30 as being obvious over the combination of Burbank, Sirimanne, and Lubock. The rejection of claims 22, 23, 26, 31, 32, and 37 as unpatentable over Burbank, Sirimanne, and Mandrusov 9 Appeal 2016-003215 Application 14/143,738 Appellants present separate arguments for claims 22, 23, and 37. App. Br. 31-38. We address each separately. Claim 22 Claim 22 depends from claim 1 and specifies that the marker fluid comprises a non-aqueous solvent with a polymeric solute “and which forms a porous bioabsorbable body in the cavity.” Appellants contend, “nowhere in Mandrusov is there any reference to a ‘porous bioabsorbable body,’ or its equivalent.” App. Br. 31. This is because the paragraph identified by the Examiner (i.e., Paragraph 62 of Mandrusov, Final Act. 6) discusses the participation/formation of particles. App. Br. 32. However, the Examiner also contends that Mandrusov discloses material that “includes a poly(lactide-co-glycolide) which is a polylactic acid and polyglycolic acid.” Ans. 10. Indeed, Paragraph 72 of Mandrusov discloses such a compound.7 Appellants’ Specification further states, “[t]he preferred relatively water- insoluble bioabsorbable polymers are polylactic acid, poly glycolic acid” or other compounds. Spec. ^ 38. Appellants do not explain how the compound referenced in Mandrusov (and also Sirimanne) and preferred by Appellants fails to teach this limitation directed to a “porous bioabsorbable body.” In other words, Appellants’ argument that Mandrusov fails to disclose the porous nature of this compound (because it is silent on this point) is not persuasive that the Examiner erred in relying on this reference for such teachings. We sustain the Examiner’s rejection of claim 22 as being obvious over the combination of Burbank, Sirimanne, and Mandrusov. 7 We further note that polylactic acid (PLA) and polyglycolic acid (PGA) are both taught in Sirimanne and that a “spongy collagen or cellulose” is preferred. See Sirimanne 8:10-16. 10 Appeal 2016-003215 Application 14/143,738 Claim 23 Claim 23 depends from claim 22 and includes limitations directed to percent, by weight, of both polylactic acid (PLA) and poly glycolic acid (PGA). The Examiner contends that it would have been obvious “that different weight ratios of PLA-PGA solute to control the release rate/bioabsorption of the copolymer” and that one skilled in the art “would have used a ratio known to last” the requisite time before being fully absorbed. Final Act. 7. The Examiner does not identify where any of the cited references disclose the recited ratio, only that the ratio would have been obvious based on a desired bioabsorption rate (Burbank desires a “period of at least 6 weeks”). Final Act. 7. Appellants, on the other hand, contend, “the cited references, taken alone or in combination, do not disclose or suggest the recited proportions of PLA and PGA used.” App. Br. 34. The Examiner’s rationale is lacking in that the Examiner relies on Burbank’s desire for a bioabsorption rate of several weeks to conclude that the specifically recited weight ratios of PLA and PGA would have been obvious. Our reviewing court has provided guidance that although the Patent Office has the initial duty of supplying the factual basis for the rejection, “[i]t may not, because it may doubt that the invention is patentable, resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in its factual basis.” In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). In short, the Examiner has not made the initial factual findings required to demonstrate a prima facie case of obviousness of claim 23. Accordingly, and based on the record presented, 11 Appeal 2016-003215 Application 14/143,738 we do not sustain the Examiner’s rejection of claim 23 reciting certain percentages, by weight, of both PLA and PGA. Claim 37 Claim 37 depends from claim 36 (which depends from independent claim 33). Claim 37 also recites a “weight ratio” for the PLA and PGA solution. For similar reasons expressed above with respect to claim 23, we do not sustain the Examiner’s rejection of claim 37 as well. Claims 26, 31, and 32 Regarding claim 26, Appellants contend that, “[cjlaim 26 depends from claim 1, and thus is patentable for at least the reasons set forth above with respect to claim 1.” App. Br. 35. This is because “Mandrusov does not overcome the deficiencies of Burbank ’034 and Sirimanne with respect to claim 1.” App. Br. 35. As above, we are not persuaded there are any deficiencies regarding the rejection of claim 1 in view of Burbank and Sirimanne, and consequently, we sustain the rejection of dependent claim 26. Regarding claims 31 and 32, both of these claims recite a ratio, by weight, of a polymeric solute. For similar reasons discussed above regarding claim 23, we are not persuaded the Examiner properly presented an initial prima facie case of obviousness in rejecting these claims. Although Appellants do not present any arguments to this effect, as we stated above, “[t]he Patent Office has the initial duty of supplying the factual basis for its rejection.” Warner, 379 F.2d at 1017. Here, because the Examiner has not made such initial factual findings as required, we likewise do not sustain the Examiner’s rejection of claims 31 and 32. 12 Appeal 2016-003215 Application 14/143,738 DECISION The Examiner’s rejections of claims 1, 21, 22, 24-30, 33, 35, and 36 are affirmed. The Examiner’s rejections of claims 23, 31, 32, and 37 are reversed. 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-IN-PART 13 Copy with citationCopy as parenthetical citation