Allen B. Kantrowitz et al.Download PDFPatent Trials and Appeals BoardAug 29, 201911560021 - (D) (P.T.A.B. Aug. 29, 2019) 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. 11/560,021 11/15/2006 Allen B. Kantrowitz KAB-10002/38 5052 13173 7590 08/29/2019 Blue Filament Law 700 E. Maple Road Suite 450 Birmingham, MI 48009 EXAMINER BARSKY, JARED ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 08/29/2019 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): ag@bluefilamentlaw.com ap@bluefilamentlaw.com patentdocketing@bluefilamentlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ALLAN B. KANTROWITZ and ROBERT D. FANELLI __________ Appeal 2017-010077 Application 11/560,021 Technology Center 1600 __________ Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and MICHAEL A. VALEK, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants1 submit this appeal under 35 U.S.C. § 134(a) involving claims to a digestive tract barrier. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants identify the Real Parties in Interest as the named inventors, Allan B. Kantrowitz and Robert D. Fanelli. App. Br. 2. Appeal 2017-010077 Application 11/560,021 2 STATEMENT OF THE CASE Appellants’ “invention in general relates to an intestinal nutrient absorption barrier and in particular to a disintegratable or segmentable barrier.” Spec. ¶ 2. As the Specification explains, obesity is one of the leading causes of death in the United States, and is associated with various co-morbidities such as higher incidences of depression and several cancers. Id. ¶¶ 3–4. Some approaches to addressing obesity include placement of an intestinal barrier that creates a physical impediment between the ingested material and the intestinal epithelial cells, thus limiting absorption of caloric intake. Id. ¶ 6. According to the Specification, some of the known barriers raise safety concerns, such as unintentional dislodgment or kinking, which can block portions of the gastrointestinal tract and require emergency surgery. Id. Moreover, concerns remain over the need for subsequent surgical procedures to safely collapse and retrieve the barrier. Id. In light of the above issues, the Specification explains, “there exists a need for a digestive tract barrier that disintegrates in a controlled manner after deployment.” Id. ¶ 8. According to the Specification, “[t]he material or stitches that make up the barrier [of the invention] disintegrate in a controlled manner from a distal end to proximal end relative to a securement that affixes the tube in a preselected position with the subject digestive tract.” Id. The Specification explains that “[d]isintegration is facilitated by formation of the barrier from biodegradable material, stitching non- degradable swatches with disintegrating stitching, or the use of a MEMS cutter.” Id.; see also id. ¶ 16 (“The barrier wall 18 is composed of multiple swatches 20 of implant-compatible non-degradable fabric or sheet Appeal 2017-010077 Application 11/560,021 3 polymer.”), ¶ 17 (“The stitching 22 is in the form of a biodegradable fiber or a scissionable nonbiodegradable fiber.”). Claims 2, 28, 29, 31, and 36–47 are on appeal. Claim 2 is illustrative, and reads: 2. A digestive tract barrier having an upper end and a lower end relative to a subject digestive tract comprising: a material having dimensions of a tube, said tube sized to deploy within the subject digestive tract, said tube comprising a plurality of material swatches of implant-compatible non- degradable polymer dimensioned such that more than one of said plurality of swatches are joined to define a diameter of the tube; a securement affixed to said tube to retain said tube in a preselected position within the subject digestive tract; stitching joining said plurality of swatches; a stitch cutter adjacent to said stitching; and a passive radiofrequency identification (RFID) tag having a RFID frequency in operative control of said stitch cutter. App. Br. 18 (Claims App.). Claim 40, the other independent claim on appeal, is similar to claim 2, but recites first and second stitch cutters adjacent, respectively, to a first and a second stitch. App. Br. 20. And, claim 40 also recites first and second passive RFID tags with different frequencies in operative control of the respective first and second stitch cutters. Id. Appeal 2017-010077 Application 11/560,021 4 The claims stand rejected2 as follows: Claims 2, 28, 29, 31, 36–38, and 40–46 under 35 U.S.C. § 103(a) as obvious over Berry,3 Kagan,4 Ertas,5 and Smith.6 Final Act. 5–10; Adv. Act. 4–9; Ans. 3–8. Claims 39 and 47 under 35 U.S.C. § 103(a) as obvious over Berry, Kagan, Ertas, Smith, Zhang,7 and Xinli.8 Final Act. 10–17; Ans. 8–15. DISCUSSION Claim Construction We begin with claim interpretation because it is a prerequisite to comparing the claims to the prior art. During prosecution, claim terms are given their broadest reasonable interpretation as understood by a person of ordinary skill in the art in light of the specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Claim 2 recites, inter alia, “[a] digestive tract barrier having an upper end and a lower end relative to a subject digestive tract comprising: . . . stitching joining a plurality of swatches; a stitch cutter adjacent to said stitching; and a passive radiofrequency identification (RFID) tag having a 2 Claims 2, 28, 29, 31, and 36–47 were also rejected under 35 U.S.C. § 112, first paragraph, for failure to comply with the written description requirement. Final Act. 5. The Examiner withdrew that rejection in the Advisory Action dated October 27, 2016 (“Adv. Act.”). Adv. Act. 2. 3 Berry, US 5,306,300, issued Apr. 26, 1994. 4 Kagan et al., US 2005/0177181 A1, published Aug. 11, 2005. 5 Ertas et al., US 7,976,461 B2, issued July 12, 2011. 6 Smith et al., US 2006/0087442 A1, published Apr. 27, 2006. 7 Zhang et al., Electrostatic micromotor and its reliability, 45 MICROELECTRONICS RELIABILITY 1230–1242 (2005). 8 Xinli et al., Advantages of Electrostatic Micromotor and Its Application to Medical Instruments, IEEE 2466–2468 (2002). Appeal 2017-010077 Application 11/560,021 5 RFID frequency in operative control of said stitch cutter.” The issue is whether claim 2 is reasonably interpreted, in light of the Specification, to encompass a collection of separate, disconnected parts of separate devices or whether the claims requires that the parts of the barrier are connected in such a way that they form a single unit. Based on our review of the Specification, we conclude that the claims9 on appeal require the recited “stitch cutter” and RFID “tag” be structures that are integral to the claimed “digestive tract barrier” itself. Claim 2, for example, requires a digestive tract barrier “comprising” a stitch cutter. Claim 2 also requires “a stitch cutter adjacent to said stitching” of the barrier, which language the Examiner earlier (and correctly) interpreted “to mean that the stitch cutter is [an] integral component of the claimed ‘digestive tract barrier.’” November 27, 2015 Office Action 3.10 As we explain below, however, in attempting to show a disclosure in the prior art satisfying this claim element, the Examiner later cites structures that are part 9 We note that the interpretation of the pending claims has been a subject of dispute on numerous occasions throughout prosecution. See July 9, 2014 Office Action 2–3 (rejecting the claims as indefinite for purportedly including components “extraneous to the digestive tract barrier itself”), November 27, 2015 Office Action 2–3 (rejecting the claims for lack of written description because the Specification allegedly “does not support ‘a digestive tract barrier’ comprising ‘a stitch cutter.’”). Although the § 112 rejections are not expressly appealed here, those rejections illustrate a lack of clarity about the proper interpretation of the claims, and prudence dictates that we get to the root of, and resolve, the claim construction issue before turning to the prior art. 10 The Examiner, however, then proceeded to reject the claims, so interpreted, as lacking written description support—apparently believing that the Specification only supported the stitch cutter being part of an extraneous device, such as on part of an endoscope. Nov. 27, 2015 Office Action 3. Appeal 2017-010077 Application 11/560,021 6 of a separate endoscopic device, and the Examiner provides no rationale to explain why it would have been obvious to include such separate structures as part of the digestive tract barrier itself. See, e.g., Ans. 6–8 (citing Ertas and Smith). Accordingly, after earlier in prosecution stating what we conclude is the correct interpretation, the Examiner later applies the prior art against the claims, advancing an incorrect interpretation, where explicitly recited claim structures need not be part of the claimed digestive tract barrier. Appellants earlier urged the correct interpretation and later amended their claims in an effort to make the integral nature of the claim elements even more clear and explicit. Indeed, in response to a statement from the Examiner that it was “unclear if Applicant is intending to include a stitch cutter as part of the implantable barrier or merely mentioning it as an additional component that is near the claimed barrier,”11 Appellants stated: Applicants do intend to include a stitch cutter as part of the implantable barrier, and this feature should be afforded patentable weight. As the pending claims are article claims in form, it is submitted that the association of the stitch cutter as part of the claimed invention represents a clear and unambiguous recitation that is consistent with the specification as[] filed. June 29, 2015 Appeal Br. 8 (emphasis added); see also March 28, 2016 Amendment and Remarks (“Claims 2 and 40 have been amended to explicitly recite that the stitch cutter is adjacent to the stitching and mounted to the tube. Thus, the stitch cutter is an integral component of the claimed digestive tract barrier[.]”). Based on the Applicants’ (Appellants’) 11 July 9, 2014 Office Action 3. Appeal 2017-010077 Application 11/560,021 7 arguments, the Examiner withdrew the action from an earlier appeal, withdrew a rejection for indefiniteness, and proceeded with further prosecution. November 27, 2015 Office Action. The Examiner, nevertheless, then rejected the claims for lack of written description support under 35 U.S.C. § 112, first paragraph. Id. at 2– 3. The Examiner’s position was that the Specification, specifically paragraph 18, described a stitch cutter as “separate and extraneous to” the digestive tract barrier, such as being part of an endoscopic cutting implement—not part of the barrier as required by the claims. Id. at 3. The Examiner’s position, however, is based on an overly narrow reading of what the Specification describes. The Examiner correctly notes that the Specification’s paragraph 18 describes “[s]cission of a nonbiodegradable fiber stitching” may involve “deployment of an endoscopic cutting implement to selectively cut portions of the barrier.” Spec. ¶ 18. But paragraph 18 plainly describes other and alternative embodiments, including embodiments that include a MEMS cutter, where the Specification describes “activating radiofrequency to the RFID tag engages the stitch cutter positioned proximal to a stich to cut the stitch thereby releasing a portion of the barrier device.” Id. And the Specification describes embodiments that comprise “deployment of multiple stitch cutters along the length of the inventive barrier.” Id. (emphasis added). On this record, we conclude the skilled artisan would reasonably understand the stitch cutters and RFID tags disposed along and integral to the barrier itself, and that the broadest reasonable interpretation of claims 2 and 40 is that the claims are drawn to such embodiments—not embodiments where the required structures are split among multiple and separate devices, such as might be implemented with a system where features of an endoscope in Appeal 2017-010077 Application 11/560,021 8 some way interoperative with features that are integral to a digestive tract barrier.12 Obviousness Turning to the asserted obviousness of the claims over Berry, Kagan, Ertas, and Smith,13 the rejection of record fails under the correct interpretation of the claims, which is discussed above. Appellants contend “[a] review of the prior art of record finds NO contemplation, teaching or motivation of RFID or microcutters in the context of, or associated with an intestinal barrier device.” App. Br. 9. We agree on this record. The Examiner does not cite any teachings in the art of using RFID tags or stitch cutters that are integral to a digestive tract barrier. Nor has the Examiner provided any persuasive, evidence-backed reasoning to demonstrate why it would have been obvious to modify the digestive barriers of Berry and/or Kagan such that the modified barriers would 12 Were it otherwise, the definiteness of the claims would be called into question. Although the earlier amendment offered by Applicants (that the structures are “mounted” to the tube/barrier) may have made the claims more explicit or clear, such additional language is not necessary as the claims already make sufficiently clear (and the Applicants argued) that the recited structures are integral to the barrier itself. See June 29, 2015 Appeal Br. 8. The Appellants apparently withdrew the proposed amended language (regarding “mounting”), which they earlier added to overcome the Examiner’s indefiniteness rejection, in order to overcome the Examiner’s later written description rejection. See Adv. Act. 2 (noting that the written description/new matter rejection was being withdrawn in view of Applicants’ claim amendments, which struck (see Ans. 15) the “mounted to said tube” language). 13 Zhang and Xinli are further relied upon only to address discrete elements of dependent claims 39 and 47. The rejection of claims 39 and 47, thus, relies on the same findings and reasoning for combining Berry, Kagan, Ertas, and Smith as pertinent to independent claims 2 and 40. Appeal 2017-010077 Application 11/560,021 9 include, for example, a stitch cutter on the barrier itself. To the contrary, the Examiner cites the combined disclosures of Ertas and Smith to show that endoscopes having RFID and cutting features would have been obvious. Ans. 6–8. But, as explained above concerning claim construction, that an endoscope may include such features does not render obvious the inclusion of those features in the digestive tract barrier itself, as recited in independent claims 2 and 40. The rejection of record also fails for at least three additional reasons. First, the Examiner does not demonstrate persuasively that the prior art discloses the claimed “plurality of material swatches . . . dimensioned such that more than one of said plurality of swatches are joined to define a diameter of the tube.” This claimed feature is illustrated in, for example, the Specification’s Figure 3, which shows multiple swatches (20) disposed around and forming the circumference of the barrier tube. Spec. Fig. 3; Reply Br. 2. As claimed, at least one swatch is on one side of the tube and a different swatch (together a “plurality” of swatches) is disposed directly opposite the first swatch on the other side of the tube—the collection of swatches together defining a “diameter” of the tube/barrier. The Examiner, citing Kagan’s teaching of a gastrointestinal sleeve comprising “segments” that may themselves biodegrade or otherwise be separated from each other by degradation of biodegradable material holding the segments together, finds that this disclosure meets the relevant claim language concerning swatches. Ans. 4–6 (citing Kagan ¶ 73). But even if Kagan’s segments were interpreted as being swatches, the Examiner fails to explain how such a structure represents a “plurality of swatches” and that “more than one of said plurality of swatches are joined to define a diameter of the tube” as claimed. The fact that Kagan’s segments (the alleged swatches) might be “small” is Appeal 2017-010077 Application 11/560,021 10 not a sufficient explanation. Ans. 19–20. And, if Kagan’s teaching is reasonably read as suggesting cylindrical or ring-shaped segments, as Appellants point out, that would not meet the claim language. Reply 3. A single ring-shaped segment is not a plurality of segments defining a diameter of the tube. Second, the Examiner does not explain where the art teaches or suggests the recited “stitching joining said plurality of swatches” as in both claims 2 and 40. Indeed, the Examiner admits that neither Berry nor Kagan disclose “stitching” as claimed. Final Act. 6 (“Berry does not teach biodegradable stitching joining said plurality of swatches”); 8 (Kagan “does not explicitly teach said biodegradable joining material is in the form of stitches.”). A vague (and seemingly inapposite) reference to use of sutures and surgical fasteners for a different purpose in Kagan is insufficient to show that the claim language is taught or suggested in the art. Final Act. 7 (citing Kagan ¶ 13). The Examiner also does not explain where, if at all, any of the remaining references disclose this claim element. Hence, there is a failure of proof on this record as to one of the explicitly recited claim elements. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (The Examiner “bears the initial burden . . . of presenting a prima facie case of unpatentability.”). Third and finally, even if we found that Kagan’s segments were non- bio-degradable “swatches” as claimed and that Kagan’s “biodegradable attachment portions,” which attach the segments, could be considered “stitching,” the rejection would still fail. The Examiner provides no persuasive, non-hindsight-based rationale for adding a mechanical cutting means—specifically, a stitch cutter—to the modified gastrointestinal sleeve of Berry and Kagan, which so modified would purport to include Kagan’s Appeal 2017-010077 Application 11/560,021 11 small non-biodegradable segments and its biodegradable attachment portions. See, e.g., Final Act. 8–9. Assuming the biodegradable attachment portions could be considered “stitching,” those portions would biodegrade at the planned degradation rate and release the non-biodegradable segments so that the segments could then pass through the rest of the gastrointestinal tract and be excreted as taught by Kagan. Why would a “stitch cutter” be necessary to mechanically cut through biodegradable portions of the gastrointestinal sleeve that would biodegrade in due course in the manner expected? The present record does not answer this question. Instead, the Examiner reasons that the skilled person would consider endoscopes with cameras and cutting devices (such as disclosed in Ertas) to remove a securement, such as sutures, set at implantation to hold a device in place. Final Act. 9. But that reasoning is detached from what is actually claimed. Absent hindsight, we see no sufficient reason provided for adding a stitch cutter to the modified sleeve of Berry and Kagan. For all the above reasons, the preponderance of the evidence on this record does not support the Examiner’s conclusion that claims 2 and 40 would have been obvious over Berry, Kagan, Ertas, and Smith. Accordingly, we reverse the rejection of claims 2 and 40 as well as the rejection of the appealed dependent claims. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) (“[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious.”). The Examiner did not assert or show that Zhang and Xinli make up for the above-noted deficiencies of Berry, Kagan, Ertas, and Smith. Appeal 2017-010077 Application 11/560,021 12 SUMMARY We reverse the rejection for obviousness on appeal. REVERSED Copy with citationCopy as parenthetical citation