Ex Parte Gaur et alDownload PDFPatent Trial and Appeal BoardSep 6, 201713039067 (P.T.A.B. Sep. 6, 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. 13/039,067 03/02/2011 Shantanu Gaur ALLRNZ00700 1052 40518 7590 09/06/2017 LEVINE BAGADE HAN LLP 2400 GENG ROAD, SUITE 120 PALO ALTO, CA 94303 EXAMINER TON, MARTIN TRUYEN ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 09/06/2017 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 SHANTANU GAUR, SAMUEL LEVY, and JONATHAN WECKER Appeal 2016-007093 Application 13/039,067 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 appeal1 under 35U.S.C. § 134 involving claims to a device for temporarily occupying a portion of a stomach. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the real party in interest as Allurion Technologies, Inc. (App. Br. 3). Appeal 2016-007093 Application 13/039,067 Statement of the Case Background “Typical weight loss treatment modalities, excluding diet and exercise, have focused either on promoting malabsorption ... or restricting gastric volume (for example, gastric bypass surgery, gastric bands, and/or intragastric balloons)” (Spec. 1:20-23). “[SJurgical interventions remain highly invasive, expensive, and only applicable to morbidly obese patients” {id. at 1:24—25). Expandable polymer systems comprised of hydrogels or cellulose derivatives have been described previously but typically suffer from limited efficacy and numerous disadvantages. Residence time in the stomach is typically less than six hours, requiring a substantial and rigorous regimen of treatment compliance to provide round-the-clock satiety. Insufficient structural integrity in the inhospitable gastric milieu typically drives this short residence time. (Spec. 2:3-7). The Claims Claims 44^48, 50-58, and 60-65 are on appeal. Claim 63 is representative and reads as follows: 63. A method of inducing weight loss in a patient comprising: positioning a construct within a stomach, such that the construct includes a fluid-permeable membrane, and a filler material enclosed within the one or more fluid permeable membrane, wherein the construct is adapted to enter the stomach of a patient in a first compressed state, and responsive to insertion into the stomach, to expand into a second expanded state, and wherein the fluid-permeable membrane is structurally unmodified in a gastric environment; and 2 Appeal 2016-007093 Application 13/039,067 delivering a degradation formulation into the stomach, such that the degradation formulation causes disruption of the structural integrity of the construct and causes release of the filler material from the construct such that the filler material passes from the stomach. The issues A. The Examiner rejected claims 44, 47, 48, 50, 51, 53—55, 57, 58, 60, and 62—65 under 35 U.S.C. § 103(a) as obvious over Kasic2 and Weitzner3 (Final Act. 4—11). B. The Examiner rejected claims 45 and 46 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, and Marco4 (Final Act. 11—13). C. The Examiner rejected claim 52 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, and Dann5 (Final Act. 13). D. The Examiner rejected claim 56 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, Dann, and Lew6 (Final Act. 14—15). E. The Examiner rejected claim 61 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, and Sampson7 (Final Act. 15). A. 35 U.S.C. § 103(a) over Kasic and Weitzner The Examiner finds Kasic teaches a device for temporarily occupying a portion of a stomach for use with a degradation material that permits release of the 2 Kasic, II, US 2009/0192535 Al, published July 30, 2009. 3 Weitzner et al., US 2008/0249635 Al, published Oct. 9, 2008 4 Marco et al., US 2007/0156248 Al, published July 5, 2007. 5 Dann et al., US 2007/0010864 Al, published Jan. 11, 2007. 6 Lew et al., US 5,167,962, issued Dec. 1, 1992. 7 Sampson et al., US 6,981,980 B2, issued Jan. 3, 2006. 3 Appeal 2016-007093 Application 13/039,067 device from the stomach (Figure 2; 20), the device comprising: a membrane (Figure 4C; 110) having at least one responsive material mechanically secured thereto to form an expandable structure having an enclosed volume (Figure 4C; 130), wherein the reference teaches that the device may have a membrane made from a first material and a second material, wherein the first and second materials are operably connected to form the enclosure volume, with one of the first or second materials having a differing degradation rate from the other (Final Act. 4). The Examiner acknowledges that Kasic “does not specifically teach a degradation material, wherein the . . . mechanical properties of the responsive material do not change until the degradation material structurally weakens the responsive material” (Final Act. 5). The Examiner finds Weitzner teaches “a device for temporarily occupying a volume of the stomach, wherein one or both elements of the device may be biodegradable or dissolvable by a solvent, which manually breaks down the material” (id.). The Examiner finds it would have been obvious to weaken the responsive material of the Kasic reference by introducing a degradation material to the stomach after a sufficient period, the degradation material being a solvent, as in the Weitzner reference, to allow for a patient to control the time of expulsion of the expandable structure from the patient’s stomach (id.). The issue with respect to obviousness is: Does the evidence of record support the Examiner’s conclusion that Kasic and Weitzner render obvious the method and constructs of claims 44, 62, and 63? 4 Appeal 2016-007093 Application 13/039,067 Findings of Fact 1. Kasic teaches “devices and methods related to treatment of obesity in animals or humans” (Kasic 12). 2. Kasic teaches the device is configured so that the maximum size of the self- expanding component is sufficiently small that each component can be passed from the stomach through the pyloric sphincter. Accordingly, the user or medical practitioner need not be worried about whether the component has appropriate biodegradation rates or that the device will obstruct the pyloric sphincter or the GI tract. (Kasic 113). 3. Kasic teaches a “swallowable self-expanding gastric space occupying device. In an aspect, the device has a membrane through which gastric liquid or fluid can pass, wherein the membrane provides an enclosure volume separated from the gastric environment by the membrane” (Kasic 114). 4. Kasic teaches “the membrane is a composite, in that it may be made from two or more distinct materials that may be different chemically to provide a different rate of degradation” (Kasic 114). 5. Kasic teaches: “Within the enclosure volume is a self- expanding component, such as a plurality of self-expanding components. The components are capable of expanding in volume upon contact with a gastric fluid, such as water for example, thereby expanding the device from an unexpanded volume to an expanded volume” (Kasic 114). 5 Appeal 2016-007093 Application 13/039,067 6. Kasic teaches: The first and second materials are operably connected to form the enclosure volume and the first material has a higher rate of decomposition in the gastric environment than the second material. The operable connection between the two materials provides a well-defined enclosure volume, but upon substantial degradation or dissolution of at least a portion of the first material, the enclosure opens, thereby releasing the self expanding components from the enclosure. (Kasic 119). 7. Kasic teaches: Materials 610 and 620 can dissolve (e.g., degrade) at different times so that after a user-selected time, an opening in the membrane becomes large enough to release the self expanding components. For example, material 620 may be a material that does not degrade or dissolve in the stomach, such as, for example a highly cross-linked polymer, a silicone-based material, or other inert material as known in the art including, but not limited to, fats, waxes, carbohydrate polymers (poly and oligosaccharides). In that situation, the dissolution of 610 results in release of material 620 from the membrane, loss of membrane integrity, release of self-expanding components 300 and movement out of the stomach and through the lower GI tract. (Kasic 181). 8. Kasic teaches that a “material that is ‘not substantially biodegradable’ refers to a material that does not significantly dissolve, erode or otherwise decompose or degrade, and maintains overall physical integrity, such as a decrease in bulk material volume or mass that is less than 10%, for a user-specified time period” (Kasic 151). 6 Appeal 2016-007093 Application 13/039,067 9. Weitzner teaches “a gastric balloon 200 . . . [that] includes a net or bag 204 which, after insertion into a desired portion of the GI tract (e.g., the stomach), is filled with a filler material until the balloon 200 takes up a desired volume” (Weitzner 116). 10. Weitzner teaches portions of the net 204 and/or the filler material may be biodegradable or dissolvable. For instance, the net 204 may be dissolvable by application of a solvent, a dissolving solution or heat, or may be designed to dissolve after a predetermined period of time after exposure to stomach fluids (e.g., three months). Once the net 204 is dissolved or manually broken, the filler material may be exposed to the same or another dissolving agent, and may be absorbed or passed through the digestive system. (Weitzner^ 16). Principles of Law “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 4—11; FF 1—10) and agree that the claims are rendered obvious by the prior art. We address Appellants’ arguments below. Appellants contend it is apparent from Kasic’s disclosure that the principle of operation or the intended purpose of Kasic is a gastric space occupying device that is tailored to degrade on its own after a well-defined time in the gastric environment of the 7 Appeal 2016-007093 Application 13/039,067 patient. Appellant has previously argued that these teachings of Kasic contradict Appellant’s claims which require a non- degradable membrane and a responsive material where the non- degradable membrane and responsive material both remain structurally unmodified in the stomach until the responsive material contacts a degradation material that is added or delivered to the stomach. (App. Br. 10). Appellants contend “while Kasic teaches a composite membrane that might include a material with a lower (or no) degradation rate, the entirety of the composite membrane is still susceptible to degradation to release the device’s components and therefore cannot be considered a non-degradable membrane” (id.). We find this argument unpersuasive because the rejection is not one that is premised on Kasic alone. Weitzner teaches several known equivalent modes of dissolution of obesity gastric devices including dissolution after a “predetermined period of time,” “dissolvable by application of a solvent,” or use of “a dissolving solution” (FF 10). Thus, although Kasic suggests an obesity gastric device that uses materials which dissolve “after a user- selected time” (FF 7) to release the components of the stomach space filling device, Weitzner’s teaching that known alternative equivalent modes of dissolution of obesity gastric devices to dissolution after a “predetermined period of time” include dissolution “by application of a solvent,” or use of “a dissolving solution” (FF 10), reasonably renders selection of these alternative modes of dissolution obvious in the absence of a secondary consideration. Our position finds substantial support in the underlying facts of the KSR decision itself, where the Supreme Court was not persuaded by the 8 Appeal 2016-007093 Application 13/039,067 Federal Circuit’s reliance upon a statement from an “expert that claim 4 was nonobvious because, unlike in Rixon, the sensor was mounted on the support bracket rather than the pedal itself.” KSR, 550 U.S. at 415. That is, like the current case, some reconstruction of the prior art elements in KSR amounting to a change in the principle of operation of the pedal sensor from mechanical to electrical would have been required to arrive at the claimed invention. The Court, however, found that “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. Here, the obvious substitution of Weitzner’s mode of controlling dissolution of gastric devices with “a dissolving solution” (FF 10) for Kasic’s mode of controlling dissolution by use of materials that dissolve “after a user-selected time” (FF 7) is such an obvious substitution. Appellants contend section [0081] of Kasic explicitly teaches a composite membrane where the mesh fabric material 610 degrades but the second material 620 does not. But this composite membrane is still designed to degrade as dissolution of the mesh fabric 610 results in release of materials 620 from the membrane - i.e., a degradable membrane. (App. Br. 12). Appellants contend “any attempts to modify Kasic to meet Appellant’s claim requirements ignore the clearly stated intended purpose of Kasic to provide a gastric space occupying device where the membrane (or composite membrane) described by Kasic degrades as a result of being placed in the patient’s gastric environment” {Id. at 12—13). 9 Appeal 2016-007093 Application 13/039,067 We find this argument unpersuasive for the reasons already discussed above and because “[n]on-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). A reference “must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” Id. Appellants’ argument fails to address the incorporation of the teachings of Weitzner that demonstrate the ordinary artisan was aware of multiple equivalent techniques for removing unwanted gastric devices including that dissolution of membrane material “by application of a solvent,” or use of “a dissolving solution” are both alternatives to a membrane that dissolves after a “predetermined period of time” (FF 10). Appellants provide no evidence that selection of these alternative modes of dissolution, suggested by Weitzner, would have been unobvious solutions to Kasic’s desire for dissolution “after a user-selected time” (FF 7). Appellants contend “that the Examiner is attempting to modify the Kasic device to comprise a fully non-degradable composite membrane but provides no discussion on why one skilled in the art would proceed contrary to the numerous explicit teaching of Kasic that discuss a degradable composite membrane” (App. Br. 13). We find this argument unpersuasive for the equivalence reasons given above and because Kasic specifically defines a “not substantially biodegradable” material (FF 8) and suggests the use of such a material in combination with another material that is “degradable” or, to use the language of claim 44, “responsive” (FF 7). Specifically, Kasic teaches 10 Appeal 2016-007093 Application 13/039,067 “material 620 may be a material that does not degrade or dissolve in the stomach” (FF 7). Kasic then teaches the embodiment where “the dissolution of 610 results in release of material 620 from the membrane, loss of membrane integrity, [and] release of self-expanding components 300” (FF 7). Thus, Kasic teaches a composite membrane composed of a non- degradable material and a second material that is degradable, reasonably rendering the device of claim 44 obvious when combined with Weitzner’s suggestion to use materials that are “dissolvable by application of a solvent” or through use of “a dissolving solution” (FF 10). Appellants contend that the Examiner used impermissible hindsight reconstruction to combine the “solvent” of Weitzner (see Weitzner, paragraph [0016]) and the modified gastric space occupying device of Kasic in order to deprecate the Appellant’s claimed invention. One of ordinary skill in the art would not have been motivated by the teachings of Kasic at the time of the invention to combine the “solvent” of Weitzner with the self-degradable device of Kasic because Kasic’s device would have no need for a solvent to aid in the breakdown of the device. (App. Br. 13). We are not persuaded. While we are fully aware that hindsight bias may plague determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1,36 (1966), we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. 11 Appeal 2016-007093 Application 13/039,067 As already discussed, Weitzner teaches three alternative approaches to dissolving the outer membrane of an obesity gastric device (FF 10), one of which is the approach chosen by Kasic (FF 7). Therefore, Weitzner clearly renders the other two approaches that fall within the scope of the claims obvious as known predictable alternatives in the absence of evidence of secondary considerations. We note that no such evidence has been argued by Appellants. We therefore agree with the Examiner that the ordinary artisan would have recognized an alternative to [Kasic’s] predetermined degradation time would be the degradation of the second material, or response material, through the introduction or a solvent or degradation material, wherein a person having ordinary skill in the art would be motivated make this modification to allow a patient to control the time of expulsion of the expandable structure from the patient’s stomach. (Ans. 4—5, citing Weitzner 116; FF 10). Conclusion of Law The evidence of record supports the Examiner’s conclusion that Kasic and Weitzner render obvious the method and constructs of claims 44, 62, and 63. B.-E. 35 U.S.C. § 103(a) rejections Appellants do not separately argue these rejections. The Examiner provides sound fact-based reasoning explaining why the further combinations of Kasic and Weitzner with Marco, Dann, Lew, and Sampson render the rejected claims obvious (see Final Act. 11—15). Having affirmed the rejection of claims 44, 62, and 63 over Kasic and Weitzner for the 12 Appeal 2016-007093 Application 13/039,067 reasons given above, we also find the further rejections render the rejected claims obvious for the reasons given by the Examiner. SUMMARY In summary, we affirm the rejection of claims 44, 62, and 63 under 35 U.S.C. § 103(a) as obvious over Kasic and Weitzner. Claims 47, 48, 50, 51, 53—55, 57, 58, 60, 64, and 65 fall with claims 44, 62, and 63. We affirm the rejection of claims 45 and 46 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, and Marco. We affirm the rejection of claim 52 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, and Dann. We affirm the rejection of claim 56 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, Dann, and Lew. We affirm the rejection of claim 61 under 35 U.S.C. § 103(a) as obvious over Kasic, Weitzner, and Sampson. 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 13 Copy with citationCopy as parenthetical citation