Ex Parte Moss et alDownload PDFPatent Trial and Appeal BoardJun 14, 201814642590 (P.T.A.B. Jun. 14, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/642,590 03/09/2015 40518 7590 06/14/2018 LEVINE BAGADE HAN LLP 2400 GENG ROAD, SUITE 120 PALO ALTO, CA 94303 FIRST NAMED INVENTOR Samuel MOSS 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. ALLRNZ00401 6384 EXAMINER TON, MARTIN TRUYEN ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 06/14/2018 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 SAMUEL MOSS, MATTHEWS. LAKE, JONATHAN WECKER, SHANTANU K. GAUR, SAMUEL G. LEVY, BRUCE A. HORWITZ, and JINYOUNG DANIEL GWAK Appeal2017-005269 Application 14/642,590 Technology Center 3700 Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and RACHEL H. TOWNSEND, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to a medical device for occupying a space within a patient's body. The Examiner rejected2 the claims as indefinite, anticipated, and obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm-in-part. 1 Appellants identify the Real Party in Interest as Allurion Technologies, Inc. (See App. Br. 3). 2 We herein refer to the Specification, filed Mar. 9, 2015 ("Spec."); Final Office Action, mailed Dec. 10, 2015 ("Final Act."); Appeal Brief, filed Nov. 14, 2016 ("App. Br."); Examiner's Answer, mailed Dec. 14, 2016 ("Ans."); and the Reply Brief, filed Feb. 14, 2017 ("Reply Br."). Appeal2017-005269 Application 14/642,590 Statement of the Case Background "Gastric bypass surgery is the current gold standard treatment for patients with a body mass index ('BMI') of greater than 40" (Spec. ,r 4). "While gastric bypass surgery results in decreased food consumption and weight loss for a majority of recipients, it requires life-altering, permanent anatomic modifications to the gastrointestinal tract and can result in severe complications" (Spec. ,r 4). "One less-invasive intervention that has begun to gain popularity is an intragastric balloon. Intragastric balloons can be placed endoscopically or positioned using other methods and generally must be removed endoscopically or rely on the body's natural digestive processes for removal" (Spec. ,r 6). The Claims Claims 1-16, 18, 21, 22, and 45 are on appeal. Independent claims 1 and 45 are representative and read as follows: 1. A medical device for occupying a space within a patient's body and for use with a fluid delivery conduit that allows transport of a fluid into the medical device, the medical device comprising: a device body defining a reservoir; a tunnel member having an elongate flattened shape, the tunnel member comprising a first open end located within the reservoir and a second open end located exterior to the device body, the tunnel member having at least two interior opposing surfaces that define a tunnel lumen extending between the first open end and the second open end; and where the tunnel lumen is sized to slidably receive the fluid delivery conduit within the second open end such that the fluid delivery conduit separates the interior opposing surfaces 2 Appeal2017-005269 Application 14/642,590 deforming the elongate flattened shape to an elongated expanded shape; wherein removal of the fluid delivery conduit causes the tunnel member to revert to the elongate flattened shape such that the interior opposing surfaces move together to narrow the tunnel lumen and increase a resistance to fluid flow through the tunnel lumen. 45. A fluid fill valve for use with a medical device for occupying a space within a patient's body and for use with a fluid delivery conduit the valve comprising: a first layer of fluid impermeable membrane and a second layer of fluid impermeable membrane, wherein a portion of the layers are sealingly joined to form a valve body, the valve body having an internal end disposed inside the device and an external end external to or at the surface of the device; wherein the first layer and second layer include an unsealed region that forms a lumen longitudinally extending in the valve body from the external end to the internal end: a substance within the lumen between the first layer and second layer that increases the resistance to fluid flow through the lumen; and where the first layer and second layer are configured to join together in the lumen reducing a diameter of the lumen region to resist passage of fluids therethrough, where the lumen is configured to permit advancement of the fluid delivery conduit therethrough. 3 Appeal2017-005269 Application 14/642,590 The Issues 3 A. The Examiner rejected claim 45 under 35 U.S.C. § I02(a)(l) as anticipated by Becker4 (Final Act. 6-7). B. The Examiner rejected claims 1, 2, 9, 10, 14, 16, 21, and 22 under 3 5 U.S.C. § I03(a) as obvious over Quijano 5 and Becker (Final Act. 8-13). C. The Examiner rejected claims 3-8 under 35 U.S.C. § I03(a) as obvious over Quijano, Becker, and Wiesner6 (Final Act. 13-14). D. The Examiner rejected claims 11-13 under 35 U.S.C. § I03(a) as obvious over Quijano, Becker, and Berman7 (Final Act. 14--15). E. The Examiner rejected claim 15 under 35 U.S.C. § I03(a) as obvious over Quijano, Becker, and Melinyshyn8 (Final Act. 15-16). F. The Examiner rejected claim 18 under 35 U.S.C. § I03(a) as obvious over Quijano, Becker, and Brister9 (Final Act. 16-17). A. 35 USC§ 102(a)(l) over Becker The Examiner finds Becker anticipates the valve of claim 45, which requires first and second layers with a lumen and "a substance within the 3 Because the Examiner, in the Advisory Action mailed Mar. 11, 2016, entered Appellants' After-Final amendment filed Feb. 9, 2016 that amended the claims to address the 35 U.S.C. § 112(b) rejection, and the Examiner does not restate this rejection in the Answer, we treat this rejection as withdrawn by the Examiner. 4 Becker, US 5,595,521, issued Jan. 21, 1997. 5 Quijano et al., US 2008/0243071 Al, published Oct. 2, 2008. 6 Wiesner et al., US 5,348,537, issued Sept. 20, 1994. 7 Berman et al., US 4,133,315, issued Jan. 9, 1979. 8 Melinyshyn et al., US 4,949,756, issued Aug. 21, 1990. 9 Brister et al., US 2010/0137897 Al, published June 3, 2010. 4 Appeal2017-005269 Application 14/642,590 lumen between the first layer and second layer that increases the resistance to fluid flow through the lumen" (see Final Act. 7; claim 45). The Examiner asserts that the heat-resistant ink of element 63 is a substance applied to an inner wall of the tunnel via the inner surface of layer 62, wherein said heat-resistant ink is applied to the film layer 62 to allow the film layers 62 and 64 to form a fluid tight seal, which increases the resistance to fluid flow through the tunnel when the seal is formed. Therefore, given that the substance of the heat-resistant ink allows for said fluid tight seal, it is therein a substance within the tunnel member that increases the resistance to fluid flow through the formation of the fluid tight seal. Furthermore, it may also be argued that any substance within the tunnel will inherently serve to increase the resistance to fluid flow through the tunnel by nature of simply decreasing the diameter of the tunnel at a specific portion of the tunnel lumen. Therefore, the heat-resistant ink on the inner wall of the film layer 62 may be interpreted as a substance that increases the resistance to fluid flow simply by decreasing the diameter of the lumen at the portion where it is applied. (Ans. 2-3). Appellants contend: The Examiner provides no support for the thickness of the applied ink. Furthermore, the Examiner ignores the texture/surface properties that the ink imparts on the valve layer. The Examiner fails to address the equally likely possibility that the application of the ink reduces a drag or a frictional resistance of fluids/liquids moving against the ink as compared to the valve film alone. (Reply Br. 3--4). The issue with respect to anticipation is: Does the evidence of record support the Examiner's conclusion that Becker teaches "a substance within the lumen between the first layer and second layer that increases the resistance to fluid flow through the lumen" as required by claim 45? 5 Appeal2017-005269 Application 14/642,590 Findings of Fact 1. Figure 7 of Becker is reproduced below: 22 40 ' ) .44 .~ ... _, ~ I r· 24 \ 63 / 28 76 32 "The ink coating 63 is applied to the bottom surface of upper valve layer 62, as shown, for example, in FIG[]. 7 ... It is important that the heat-resistant ink 63 be applied in the region of bonding portion 56 to prevent unintentional valve closure during balloon manufacture" (Becker 5:5-9). Principles of Law "Inherency ... may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). Analysis We find that Appellants have the better position because there is no evidence in Becker that the ink coating layer 63 "increases resistance to fluid flow through the lumen" as required by claim 45. In the Specification, the substances that increase resistance can be a hygroscopic material, a material swells upon contact with the patients bodily fluids or a liquid within the reservoir, a low-solubility material, a bio-compatible lubricant, and/or a viscous material where after removal of the fluid delivery member a cohesion of the viscous material increases a force required to separate the interior opposing surfaces. 6 Appeal2017-005269 Application 14/642,590 (Spec. ,r 12). Notably absent from this description of materials that increase resistance is "ink." We also are not persuaded by the Examiner's reasoning that an "ink coating layer" would inherently constrict the passageway and thereby inherently increase resistance (see Ans. 2-3). Becker does not apply the ink for such a purpose, applying the ink instead to prevent bonding during balloon manufacture thereby "prevent[ing] unintentional valve closure during balloon manufacture" (See, e.g., Becker 4:65-5: 10). Moreover, as Appellants point out, inks which reduce the coefficient of drag may reduce, not increase, flow resistance (see Reply Br. 3--4 ). The Examiner has not provided evidence whether the ink coating layer in Becker has a frictional coefficient that would be expected to increase or decrease resistance relative to the layers on which it is coated. Therefore the Examiner does not provide the factual predicate necessary for establishing that Becker's "ink coating layer" necessarily serves to increase resistance. In addition, the Examiner has not established a prima facie case under the burden shifting rationale of In re Best, 562 F.2d 1252, 1254--55 (CCPA 1977), because the Examiner does not identify any specific inks used as coating layers in Becker that Appellants could test in order to rebut the inherency position. Conclusion of Law The evidence of record does not support the Examiner's conclusion that Becker teaches "a substance within the lumen between the first layer and second layer that increases the resistance to fluid flow through the lumen" as required by claim 45. 7 Appeal2017-005269 Application 14/642,590 B. 35 US.C. § 103(a) over Quijano and Becker The Examiner finds Quijano teaches a "medical device for occupying a space within a patient's body and for use with a fluid delivery conduit that allows transport of a fluid into the medical device [], the medical device comprising: a device body defining a reservoir [] and a valve for introducing fluid into the reservoir" (Final Act. 8). The Examiner acknowledges Quijano "does not specifically teach the specific structure of said valve" (Id.). The Examiner finds Becker teaches "a self-sealing valve system for inflatable structures, wherein the valve comprises a tunnel member having an elongate flattened shape" where the fluid delivery conduit separates the interior opposing surfaces deforming the elongate flattened shape to an elongated expanded shape [], wherein removal of the fluid delivery conduit causes the tunnel member to revert to the elongate flattened shape such that the interior opposing surfaces move together to narrow the tunnel lumen (Final Act. 8-9). The Examiner finds it obvious "to have the valve of the Quijano reference have the same structure as that of the Becker reference to provide an improved valve which may be inexpensively produced" (Id. at 9). The issue with respect to obviousness is: Does the evidence of record support the Examiner's conclusion that Quijano and Becker suggest a medical device with a valve as required by claim 1? Findings of Fact 2. Quijano teaches "intragastric balloons for treatment of morbid obesity" (Quijano 2). 8 Appeal2017-005269 Application 14/642,590 3. Figure 5 of Quijano is reproduced below: Fl(}. 5 "FIG. 5 shows an overall view of a 2-balloon gastric space filler system 10 of the present invention. The system may comprise an entrance section 11, a first balloon section 12, a second balloon section 14, an inter-balloon section 13, and a drug dispensing section 15" (Quijano ,r 53). 4. Quijano teaches that a "first drug reservoir pouch 27 A in the first balloon, the second drug reservoir pouch 27B in the second balloon and the drug reservoir 27C in the inter-balloon section may be in controlled fluid communication" (Quijano ,r 59). 5. Becker teaches "an improved valve for use with balloons" (Becker 1: 50-51) where the "present invention helps to insure the formation of a continuous tubular passageway which extends from the neck of the balloon to the balloon interior" (Becker 6: 1-3). 9 Appeal2017-005269 Application 14/642,590 6. Figures 1 and 2 of Becker are reproduced below: Fig. 1 Fig. 2 In the preferred embodiment, the valve 50 is inserted between balloon film layers 12, 14 and is bonded to the balloon films by the same operation which seals the marginal edges of the balloon films. As shown in FIGS. 1 and 2, for example, in a single step the various layers of assembly 10 are bonded together with heated dies conforming to the outer periphery of the balloon films (including heat-sealing portions 54, 58), as well as the cross sealing or valve seal 56 at the center of the "H" pattern. (Becker 4:7-15). 7. Figure 8 of Becker is reproduced below: ( 64 12 ) p· 8 .... tg. ' 1 63 14 10 i " 56 76 36 Appeal2017-005269 Application 14/642,590 "FIG. 8 is a view similar to that of FIG. 7 showing the probe at a later stage of insertion" (Becker 2:19--20). 8. Figure 12 of Becker is reproduced below: 50 Fig. 12 ... 14 "FIG. 12 is a cross-sectional view taken along the line 12-12 of FIG. 2, but shown after inflation" (Becker 2:28-29). Principles of Law "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 8-13; FF 1-8) and agree that the claims are obvious over the cited prior art. We select claim 1 as representative. 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv) ("[T]he failure of appellant to separately argue claims which appellant has grouped together shall constitute a waiver of any argument that the Board must consider the patentability of any grouped claim separately.") We address Appellants' arguments below. Appellants contend "the valve of Becker does not extend beyond the device body but remains within a neck of the balloon" (App. Br. 13). 11 Appeal2017-005269 Application 14/642,590 Appellants further contend "Becker teaches against insertion of any member through the valve otherwise the valve would stretch and fail to function as a valve" (Id.). We find these arguments unpersuasive because we agree with the Examiner that claim 1 "simply states that the valve must be sized to slidably receive the fluid delivery conduit within the second open end. This limitation does not suggest that the entirety of the conduit must be inserted to run through the valve" (Ans. 4). Even if we treated this functional recitation as having some structural consequence, Schreiber teaches that writing a claim that mixes structural and functional limitations comes at a price. In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). ("[C]hoosing to define an element functionally, i.e., by what it does, carries with it a risk."). The price is that when the structural limitations are met by a single prior art reference, and when the examiner "has reason to believe" that the prior art reference inherently teaches the functional limitation, the burden shifts to the patent applicant to show that the functional limitation cannot be met by the single prior art reference. Id.; see also Best, 562 F.2d at 1254--55 (CCPA 1977). Here the Examiner reasonably finds that the tip of the conduit, or the needle, shown in the Becker reference may slidably be received into the valve to fill the balloon without stretching the valve, as shown in Figures 7 and 8 of the Becker reference, [therefore] the reference does in fact teach the limitation and operation of the device as recited in the claims [and] would not render the device inoperable. (Ans. 4). That is, Figure 8 of Becker shows inflation probe 40 with tip 42 slidably received by valve 50 in the lumen defined by valve film layers 62 and 64 (FF 7) consistent with the requirement of claim 1. 12 Appeal2017-005269 Application 14/642,590 Appellants contend "Becker does not teach or suggest positioning of any conduit through the valve but instead teaches the use of slits at the opening of the valve to allow nesting of a probe within the slit area" (App. Br. 14). Appellants contend "the Examiner's assertion of stretching the valve cannot be satisfied by Becker under an anticipation analysis" (Id.). We find this argument unpersuasive because the rejection is for obviousness, not anticipation. It is the combination of Becker and Quijano, and what these references suggest together, not what either reference independently teaches, that renders claim 1 obvious. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As already noted, Figure 8 of Becker reasonably shows tip 42 slidably received by valve 50 (FF 7). Appellants contend "the Examiner does not provide any rationale as to why one would proceed contrary to the teaching of Becker and position any conduit through the valve seal or even how one would position a conduit having sufficient column strength through the delicate valve without damaging the valve" (Id. at 14). Appellants contend "Becker teaches against delivery of an inflation mechanism through the valve to deform from an elongated flattened shape to an elongated expanded shape. As noted above, Quijano does not teach this requirement either" (App. Br. 15). We find these arguments unpersuasive, both for the reasons given above regarding the functional nature of the limitation and because Appellants do not identify a teaching in Becker that discourages, discredits, or otherwise teaches away from any particular placement of the conduit in 13 Appeal2017-005269 Application 14/642,590 the valve. A teaching away requires a reference to actually criticize, discredit, or otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) ("The prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed"). The specific teaching identified by Appellants in column 1, lines 34--37 of Becker are drawn to prior art valves, not to the valves of Becker. Appellants contend: "An elongate expanded shape is not the same as an expanded shape. Clearly, claims 1 and 21 require that the tunnel lumen can receive the fluid delivery conduit to form an elongated expanded shape" (Reply Br. 5). We find this argument unpersuasive because we agree with the Examiner that the "fluid delivery conduit separates the interior opposing surfaces deforming the elongate flattened shape to an elongated expanded shape (Figure 8; 36)" (Final Act. 8). Neither Claim 1 nor the Specification define the extent of elongation required for either an "elongate flattened shape" or "an elongated expanded shape." Figures 7 and 8 of Becker show transition of a conduit from the flattened shape in Figure 7 to an expanded shape in Figure 8 that is elongate to some degree. Moreover, Becker teaches "the formation of a continuous tubular passageway" (FF 5) that is reasonably interpreted as an "elongate expanded shape." Thus, both a reasonable reading of Becker and a reasonable interpretation of the phrase "elongated expanded shape" support the Examiner's obviousness position. Conclusion of Law 14 Appeal2017-005269 Application 14/642,590 The evidence of record supports the Examiner's conclusion that Quijano and Becker suggest a medical device with a valve as required by claim 1. C. 35 US.C. § 103(a) over Quijano, Becker, and Wiesner Appellants contend "Becker does not teach or suggest any substance within its valve that increases a resistance to fluid flow through the lumen upon removal of a fluid delivery member" (App. Br. 16). Appellants contend: (Id.) One of skill in the art, using the teachings of Becker, would avoid putting extraneous materials in the valve given that such materials will increase the tension upon the valve film leading to deformation. The addition of Wiesner does nothing to address the contrary teachings of Becker, which cautions against stretching of the valve and teaches away from putting a substance into the valve[.] The Examiner responds "Becker does not contain contrary teachings with respect to the claimed invention" (Ans. 6). We find the Examiner has the better position. Becker does not teach away from valve stretching, as noted above, and Becker clearly suggests placing an ink coating in the valve (FF 1 ), even if that coating may or may not inherently result in increased resistance to fluid flow. Wiesner teaches the inclusion of a "lubricious material" where "[ u Jpon contact with an aqueous based liquid, the lubricous material causes the polymer material defining the bearing surface to swell, thereby sealing the interface between the bearing surface and the movable member so as to prevent the passage of a significant amount of liquid therethrough" (Wiesner 3 :22-2 7). The 15 Appeal2017-005269 Application 14/642,590 Examiner reasonably finds it obvious to combine Becker, Quijano and Wiesner to "additionally include the swellable substance of the Wiesner reference to further prevent the passage of significant amounts of liquid through the valve after removal of the fluid conduit" (Final Act. 14 ). D.-F. 35 US.C. § 103(a) Appellants do not separately argue these obviousness rejections, instead relying upon their arguments to overcome the combination of Quijano and Becker. The Examiner provides sound fact-based reasoning for combining each of Berman, Melinyshyn, and Brister (see Final Act. 14--17). Having affirmed the obviousness rejection of claim 1 over Quijano and Becker for the reasons given above, we also find that the further combinations render the rejected claims obvious for the reasons given by the Examiner. SUMMARY In summary, we reverse the rejection of claim 45 under 35 U.S.C. § 102( a )(1) as anticipated by Becker. We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Quijano and Becker. Claims 2, 9, 10, 14, 16, 21, and 22 fall with claim 1. We affirm the rejection of claims 3-8 under 35 U.S.C. § 103(a) as obvious over Quijano, Becker, and Wiesner. We affirm the rejection of claims 11-13 under 35 U.S.C. § 103(a) as obvious over Quijano, Becker, and Berman. We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as obvious over Quijano, Becker, and Melinyshyn. 16 Appeal2017-005269 Application 14/642,590 We affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as obvious over Quijano, Becker, and Brister. 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 17 Copy with citationCopy as parenthetical citation