Ex Parte Hadba et alDownload PDFPatent Trial and Appeal BoardJun 20, 201612527445 (P.T.A.B. Jun. 20, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/527,445 08/17/2009 50855 7590 06/22/2016 Covidien LP 555 Long Wharf Drive Mail Stop SN-I, Legal Department New Haven, CT 06511 FIRST NAMED INVENTOR Ahmad R. Hadba 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. H-US-00601 (203- 5140) 4687 EXAMINER NEGARESTAN, FARSHAD ART UNIT PAPER NUMBER 3768 NOTIFICATION DATE DELIVERY MODE 06/22/2016 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): mail@cdfslaw.com SurgicalUS@covidien.com medtronic_mitg-si_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AHMAD R. HADBA and RUSSELL HEINRICH1 Appeal2014-002038 Application 12/527,445 Technology Center 3700 Before NINA L. MEDLOCK, ROBERT L. KINDER, and KENNETH G. SCHOPPER, Administrative Patent Judges. KINDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants seek our review under 35 U.S.C. § 134(a) of the Examiner's final rejection of claims 1--4, 6, 7, 9-13, and 15-20. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM-IN-PART. 1 The Appellants identify Covidien LP as the real party in interest. App. Br. 1. Appeal2014-002038 Application 12/527,445 Appellants' Invention Appellants' invention "relates to methods for endoscopic polypectomy," including "the use of sensors and materials which permit excellent visualization of a polyp during an endoscopic procedure and, where necessary, the removal of such a polyp." Spec. ,-r 2. Claim on Appeal Claims 1 and 12 are the only independent claims on appeal. These claims are illustrative of the subject matter on appeal: 1. A method comprising: introducing at least one media comprising at least one thermally responsive polymer into tissue comprising submucosa of a polyp; measuring a response to an external stimuli in the tissue, the external stimuli being separate from the media and selected from the group consisting of palpation, an air puff, and a light source under the polyp; and deducing a state of health of the tissue depending on the response to external stimuli. 12. A system comprising: a cannula for introducing at least one media comprising at least one thermally responsive polymer into tissue comprising submucosa of a polyp; and at least one sensor for determining changes in the tissue, wherein the cannula further comprises a pressure sensor for determining the pressure of the media in the submucosa. App. Br. 19-21 (Claims App'x). Examiner's Rejections I. Claims 1, 2, 7, and 9 are rejected under 35 U.S.C. § 103(a) over Scopton (US 2006/0070631 Al, pub. Apr. 6, 2006) and de la Torre (US 7,033,373 B2, Apr. 25, 2006). II. Claim 3 is rejected under 35 U.S.C. § 103(a) over Scopton, de la Torre, and Machida (US 4,411,257, Oct. 25, 1983). 2 Appeal2014-002038 Application 12/527,445 Ill. Claims 4, 6, 10, and 11 are rejected under 35 U.S.C. § 103(a) over Scopton, de la Torre, and Bryan (US 6,596,257 B2, July 22, 2003). IV. Claims 12, 13, and 20 are rejected under 35 U.S.C. § 103(a) over Scopton and Glowa (US 6,086,542, July 11, 2000). V. Claims 15-18 are rejected under 35 U.S.C. § 103(a) over Scopton, Glowa, and Bryan. VI. Claim 19 is rejected under 35 U.S.C. § 103(a) over Scopton, Glowa, Machida, and Hayafuji (US 5,634,463, June 3, 1997). ANALYSIS Claims 1, 2, 7, and 9 Appellants first contend that Scopton fails to "disclose or suggest subjecting a polyp to an external stimuli such as palpation, an air puff, or a light source under the polyp." App. Br. 7. Appellants further contend "[a] dye included in the media introduced with the submucosa of a polyp is clearly distinguishable from an external stimuli separate from the media, as recited in the claims." Id. Appellants' contentions are not commensurate in scope to the language of claim 1. Claim 1 requires "introducing at least one media comprising at least one thermally responsive polymer into tissue comprising submucosa of a polyp; measuring a response to an external stimuli in the tissue." Id. at 19. Claim 1 does not require "subjecting a polyp to an external stimuli" as Appellants contend. Instead, claim 1 requires measuring a response to an external stimuli in the tissue. Although the tissue comprises submucosa of a polyp, use of the term "comprising" is open ended, meaning the tissue is not limited to just submucosa of a polyp. See Ans. 8 ("The 3 Appeal2014-002038 Application 12/527,445 tissue comprises the submucosa of a polyp. So, the tissue is not limited to the polyp and its submucosa, but rather the tissue can include stomach wall."); see also MPEP § 2111. 03 ("The transitional term 'comprising', which is synonymous with 'including,' 'containing,' or 'characterized by,' is inclusive or open-ended and does not exclude additional, unrecited elements or method steps."). Thus, the Examiner need not show that the combination of prior art teaches subjecting a polyp to an external stimuli as Appellants contend. Further, the Examiner does not rely on the dye disclosed in Scopton as "an external stimuli in the tissue." See Ans. 3 ("Scopton does not explicitly disclose measuring a response to external stimuli"). Instead, the Examiner relies on de la Torre's teaching "of an endoscope to observe (i.e. measure the response by a camera) a patient's stomach while it is palpated" as corresponding to the claimed external stimuli. Id. Thus, the Examiner relies on de la Torre's palpation as the external stimuli. Id. Appellants also contend "nowhere does de la Torre disclose or suggest its device might be suitable for use in tissue comprising the submucosa of a polyp, as recited in independent claim 1." App. Br. 7. According to Appellants, "while de la Torre suggests using palpation as a means for determining the proper location for an incision to introduce its device into the stomach," it fails to "suggest introducing a stimuli to a polyp, including palpation ... and deducing a state of health of the tissue depending on the response to the external stimuli, as recited in claim 1." Id. at 8. The Examiner relies on Scopton as teaching introduction of at least one media comprising at least one thermally responsive polymer into tissue comprising submucosa of a polyp. Ans. 3, 8. Appellants also recognize, 4 Appeal2014-002038 Application 12/527,445 Scopton teaches a "the media introduced with the submucosa of a polyp .... " App. Br. 7. The Examiner relies on de la Torre as teaching use of "an endoscope to observe the response of the gastric surface (stomach wall) to external palpation." Ans. 8. The Examiner finds that because Scopton teaches using endoscopes for diagnosis of gastrointestinal (GI) tract, and because it is well known to use an endoscope for the observing the response of the tissue to palpation (the claimed stimuli), one of ordinary skill in the art would recognize the suitability of using the endoscope of Scopton for observing the response of the GI tissue to external palpation as taught by de la Torre. We find no error in the Examiner's findings. Appellants' arguments are also premised on claim 1 requiring "introducing a stimuli to a polyp" (App. Br. 8), which, as discussed above, is not commensurate in scope to the actual claim language. Scopton discloses that the thermally responsive polymer is injected to the submucosa of a polyp to facilitate endoscopic procedures, and de la Torre teaches palpating a patient's tissue and observing the response to the palpation by an endoscope. See Ans. 3. We agree with the Examiner that it would have been obvious "to apply palpation and endoscopic observation as taught by de la Torre in the method of Scopton to diagnose the state of health of the patient" as required by claim 1. Id. at 3--4. For the reasons set forth above, and for the reasons provided by the Examiner, we sustain the Examiner's rejection of claim 1 under 35 U.S.C. § 103(a) over Scopton and de la Torre. Because Appellants do not separately argue claims 2, 7, and 9, apart from their dependency from claim 1, we likewise sustain the Examiner's rejection of claims 2, 7, and 9 under 35 U.S.C. § 103(a) over Scopton and de la Torre. 5 Appeal2014-002038 Application 12/527,445 Claim 3 Claim 3 recites "[t]he method of claim 1, wherein the external stimuli comprises an air puff and measuring the response is performed with a device comprising a tonometer." App. Br. 13 (Claims App'x). The Examiner finds Machida teaches an inspection endoscope used to examine a colon, including a tonometer to obtain tension information and a pressure gauge to obtain information regarding pressure in the colon. Ans. 4. The Examiner further finds a tonometer as disclosed by Machida encompasses an air tonometer which measures the response of the tissue to a stimuli from an air puff. Id. at 9. Appellants contend Machida's reference to tonometers for use in the colon does not disclose or suggest measuring a response to an external stimuli such as an air puff, nor does Machida' s reference to pressure gauges suggest a system including a cannula having a pressure sensor for determining the pressure of the media in the submucosa. App. Br. 19; Reply Br. 3. The Examiner has not persuasively established that Machida's general reference to data "displayed on a tonometer" or "a data device 44 such as a pressure gauge" relates to the claim limitation requiring an air puff and measuring the response of the air puff by a tonometer. See Ans. 4 (citing Machida, col. 1, 11. 53-55, col. 3, 11. 5-8). Likewise, Machida's general mention of obtaining data concerning "the inner pressure of the colon" does not necessarily relate to an external stimuli (air puff) being measured in the tissue as required by claim 3. Machida, col. 3, 11. 32-38. For the reasons set forth above, and based on the record before us, we do not sustain the Examiner's rejection of claim 3. 6 Appeal2014-002038 Application 12/527,445 Claims 4, 6, 10, and 11 Initially, we note that Appellants argue the Examiner's rejection of claims 4, 6, 10, and 11 is erroneous for reasons similar to those that Appellants argue the rejection of claim 1 is erroneous. See App. Br. 12-13. Inasmuch as we are not persuaded by any of Appellants' arguments regarding claim 1, we sustain the rejections of claims 4, 6, 10, and 11. Appellants also contend Bryan does not disclose the light sources recited in claims 4 and 6. App. Br. 13; Reply Br. 4. Appellants, however, fail to provide any explanation as to why or how the Examiner erred. See 37 CPR§ 41.37(c)(l)(iv) ("The arguments shall explain why the examiner erred as to each ground of rejection contested by appellant." (emphasis added)). As such, we find Appellants' contention unpersuasive. See also Ans. 5 (Examiner finding "bioluminescence agent (e.g. Renilla luciferase, Col. 32, L. 36-39) ... as a light source"). Claims 12, 13, and 20 Initially, we note that Appellants argue the Examiner's rejection of claims 12, 13, and 20 is erroneous for reasons similar to those that Appellants argue the rejection of claim 1 is erroneous. See App. Br. 14; Reply 4. Inasmuch as we are not persuaded by any of Appellants' arguments regarding claim 1, we sustain the rejection of claims 12, 13, and 20. Appellants also contend "nowhere does Glowa disclose or suggest the use of its device to introduce a thermally responsive polymer into the submucosa of a polyp." Reply Br. 4. We find this contention unpersuasive. First, Appellants contention is not commensurate in scope to claim 12, which requires "introducing at least one media comprising at least one 7 Appeal2014-002038 Application 12/527,445 thermally responsive polymer into tissue comprising submucosa of a polyp." App. Br. 21. Next, the Examiner relies on Scopton, and not Glowa, as teaching this limitation. See Ans. 6 ("Scopton discloses a system comprising: a cannula ... for introducing at least one media comprising at least one thermally responsive polymer ... into tissue comprising submucosa of a polyp."). Appellants next argue the Examiner erred in finding that Glowa's pressure sensor could be used with any device, and Glowa does not, in fact, suggest the use of a pressure sensor on any cannula, or in the system recited in claim 12. App. Br. 14. The Examiner finds "Glowa teaches a cannula for enabling fluid inflow (i.e. injection) during endoscopic procedures (abstract) which is equipped with a pressure sensor to determining the pressure of a media." Ans. 6. Thus, according to the Examiner, "it would have been obvious to one of ordinary skill in the art at the time of the invention to apply a pressure sensor as taught by Glowa in the cannula of Scopton to determine the pressure of the media in the submucosa." Id. The Examiner's findings are persuasive. Glowa's device is described for use in endoscopic surgical procedures. Glowa, col. 1, 11. 9-10; see also id. at col 1, 11. 38--40 ("Pressure sensing devices may be provided in a variety of configurations depending upon ... the particular surgical procedure."). Thus, we find no error in the Examiner's determination that Glowa' s pressure sensor could be applied to the cannula of Scopton to determine the pressure of the media in the submucosa. For the reasons set forth above, and for the reasons provided by the Examiner (Ans. 6, 10), we sustain the Examiner's rejection of claim 12 8 Appeal2014-002038 Application 12/527,445 under 35 U.S.C. § 103(a). Because Appellants do not separately argue claims 13 and 20 apart from their dependency from claim 12, we likewise sustain the Examiner's rejection of claims 13 and 20 under 35 U.S.C. § 103(a). Claims 15-18 Initially, we note that Appellants argue the Examiner's rejection of claims 15-18 is erroneous for reasons similar to those that Appellants argue the rejection of claim 12 is erroneous. See App. Br. 15. Inasmuch as we are not persuaded by any of Appellants' arguments regarding claim 12, we sustain the rejection of claims 15-18. Appellants also contend that Bryan fails to teach or suggest "thermally responsive polymers" and "a cannula having a pressure sensor." Id. However, the Examiner does not rely on Bryan as teaching these limitations. See Ans. 6, 7, 10. For the reasons set forth above, and for the reasons provided by the Examiner (Ans. 6, 7, 10), we sustain the Examiner's rejection of claims 15- 18 under 35 U.S.C. § 103(a). Claim 19 Claim 19 recites "[t]he system of claim 12, wherein the sensor comprises an air tonometer." App. Br. 22. Claim 12 also recites "at least one sensor for determining changes in the tissue." Id. at 21. The Examiner finds that Scopton and Glowa disclose the invention substantially as claimed, except for an air tonometer. Ans. 7. According to the Examiner, "Machida teaches an inspection endoscope that can be used to examine a colon (abstract)," and also a tonometer to obtain tension information of the colon. Id. The Examiner's finds that "Hayafuji teaches an air tonometer to accurately measure intraocular pressure of a subject's 9 Appeal2014-002038 Application 12/527,445 eye." Id. The Examiner explains "Hayafuji is relied upon for teaching a non-contact air tonometer as an alternative for [the] tonometer of Machida." Id. at 11. The Examiner determines it would have been obvious to one of ordinary skill in the art at the time of the invention to apply an air tonometer as taught by Machida and Hayafuji in the system and method of Scopton to measure pressure of the media in the polyp and obtain tension information of the polyp. Id. at 7-8. Appellants contend that Machida fails to "suggest a system including a cannula having a pressure sensor for determining the pressure of media in the submucosa of a polyp." App. Br. 16. Appellants contend Hayafuji discloses a non-contact tonometer capable of measuring intraocular pressure of a subject's eye, but the reference fails to teach the requirements of claim 19. Appellants also contend the Examiner engaged in impermissible hindsight, "as one skilled in the art would have no reason to use the ocular tonometer of Hayafuji for treating and/or removing polyps." Id. at 17. Appellants' arguments focus on the references individually without consideration of the combination proposed by the Examiner. See App. Br. 16-17; Reply Br. 6. Appellants' contentions also argue limitations that are not required by the claims. See Ans. 11 ("it is noted that the features upon which applicant relies (i.e., use the ocular tonometer of Hayafuji for treating and/or removing polyps) are not recited in the rejected claim(s)"). For example, claims 12 and 19 require a tonometer "for determining changes in the tissue." App. Br. 20-22. We agree with the Examiner that Hayafuji's non-contact air tonometer integrated with Machida's colon tonometer would be suitable for determining changes in the tissue as claimed. We also agree that the Examiner has provided a persuasive rationale for why one of 10 Appeal2014-002038 Application 12/527,445 ordinary skill in the art would integrate Hayafuji for its teachings of a non- contact tonometer capable of measuring pressure into the colon tonometer of Machida. See Ans. 7-8, 11. Further, Appellants' contention that one skilled in the art would have no reason to use the ocular tonometer of Hayafuji for treating or removing polyps is not commensurate in scope to claim 12, as discussed above. For the reasons set forth above, and for the reasons provided by the Examiner (Ans. 7, 10-11), we sustain the Examiner's rejection of claim 19 under 35 U.S.C. § 103(a). CONCLUSION The rejection of claims 1, 2, 7, and 9 under 35 U.S.C. § 103(a) over Scopton and de la Torre is affirmed. The rejection of claim 3 under 35 U.S.C. § 103(a) over Scopton, de la Torre, and Machida is reversed. The rejection of claims 4, 6, 10, and 11 under 35 U.S.C. § 103(a) over Scopton, de la Torre, and Bryan is affirmed. The rejection of claims 12, 13, and 20 under 35 U.S.C. § 103(a) over Scopton and Glowa is affirmed. The rejection of claims 15-18 under 35 U.S.C. § 103(a) over Scopton, Glowa, and Bryan is affirmed. The rejection of claim 19 under 35 U.S.C. § 103(a) over Scopton, Glowa, Machida, and Hayafuji is affirmed. 11 Appeal2014-002038 Application 12/527,445 DECISION We AFFIRM the Examiner's final rejection of claims 1, 2, 4, 6, 7, 9- 13, and 15-20. We REVERSE the Examiner's decision to reject claim 3. 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 12 Copy with citationCopy as parenthetical citation