Ex Parte Borgert et alDownload PDFPatent Trial and Appeal BoardJul 18, 201713883603 (P.T.A.B. Jul. 18, 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. 13/883,603 05/06/2013 Jorn Borgert 2010P01035WOUS 7903 24737 7590 07/20/2017 PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS EXAMINER 465 Columbus Avenue SMITH, RUTH S Suite 340 Valhalla, NY 10595 ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 07/20/2017 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): marianne. fox @ philips, com debbie.henn @philips .com patti. demichele @ Philips, com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JORN BORGERT, INGO SCHMALE, JURGEN ERWIN RAHMER, BERNHARD GLEICH, and MICHAEL HARALD KUHN1 Appeal 2016-007351 Application 13/883,603 Technology Center 3700 Before JOHN E. SCHNEIDER, TIMOTHY G. MAJORS, and DAVID COTTA, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for imaging the colon which have been rejected for failing to satisfy the written description requirement, as indefinite, as anticipated, and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellant identifies the Real Party in Interest as Koninklijke Philips N.V. Appeal Br. 4. Appeal 2016-007351 Application 13/883,603 STATEMENT OF THE CASE Colon screening typically involves an endoscopic colonoscopy where a CCD or fiber optic camera on a flexible tube is passed through the anus. Spec. 2. While this technique provides a visual diagnosis of the examined area and permit’s biopsy or removal or lesions, the technique also brings about a risk of bowel perforation. Spec. 2. The Specification describes a non-invasive technique for imaging the colon using Magnetic Particle Imaging. Spec. 1. Claims 1—16 are on appeal. Claims 1 and 7 are the sole independent claims and read as follow: 1. A method for collecting data by using Magnetic Particle Imaging comprising the steps of: (a) pre-delivering magnetic particles to a colon of a subject; (b) generating an imaging magnetic field with a spatial distribution of the magnetic field strength such that an area of examination in the colon consists of a first sub-area of the colon with lower magnetic field strength, where the magnetization of magnetic particles which were pre-delivered to the colon is not saturated, and a second sub-area of the colon with a higher magnetic field strength, where the magnetization of said magnetic particles is saturated; (c) changing the spatial location of both sub-areas in the area of examination so that the magnetization of said particles changes locally; and (d) acquiring signals that depend on the magnetization in the area of examination influenced by this change, wherein the area of examination in the colon comprises a portion or segment of the colon and wherein steps (b) to (d) are carried out during an entire peristaltic cycle in said colon portion or segment, followed by a reassignment of the area of examination to a different portion or segment of the colon. 2 Appeal 2016-007351 Application 13/883,603 7. A food stuff configured for in vivo screening for cancerous diseases of the colon, colon inflammation, polyps, gastrointestinal patency or transit, or mucosa defects of the colon by Magnetic Particle Imaging comprising a magnetic particle suitable for Magnetic Particle Imaging, wherein said magnetic particle is an iron oxide particle which includes a coating, said iron oxide particle being resistant to gastrointestinal breakdown, wherein said food stuff is free of components which enhance the excretion of the magnetic particle. The claims stand rejected as follows: Claim 16 has been rejected under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 Claims 1—16 have been rejected under 35 U.S.C. § 112, second paragraph, as indefinite. Claim 7 has been rejected under 35 U.S.C. § 102(b) as anticipated by Boeve.3 Claims 1—6, 8, 9, 12—14, and 16 have been rejected under 35 U.S.C. §103 (a) as unpatentable over Boeve in view of Horn4, Geiger,5 or Loewke.6 2 In the Final Action mailed Aug. 31, 2015, the Examiner rejected claims 1— 16 under 35 U.S.C. § 112, first paragraph as (b) not being enabled. The Examiner has withdrawn this rejection. Ans. 5. 3 Boeve, WO 2009/074952 A2, published June 18, 2007 (“Boeve”). 4 Horn, US 2007/0078335 Al, published Apr. 5, 2007 (“Horn”). 5 Geiger et al., US 2008/0175459 Al., published July, 24, 2008 (“Geiger”). 6 Loewke et al., US 2010/0149183 Al, published June 17, 2010 (“Loewke”). 3 Appeal 2016-007351 Application 13/883,603 Claims 10, 11, and 15 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Boeve in view of Horn or Geiger or Loewke in further view of Johnston7, Doyle,8 or Bikram.9 WRITTEN DESCRIPTION Issue The issue is whether the evidence of record supports the Examiner’s finding that claim 16 fails to meet the written description requirement. The Examiner finds the Specification fails to contain any example as to how the peristaltic cycle of a patient can be determined. Final Act. 2. Appellants contend that the Specification describes how to determine a peristaltic cycle. Appeal Br. 9. In addition, Appellants contend that: a peristaltic cycle is a clearly observable biological process and a person with ordinary skill in the art would readily understand that the approximate time of a patient’s peristaltic cycle can be determined, for example, by observing the peristaltic movements during imaging. Therefore, a person with ordinary skill in the art would reasonably conclude that Applicants possessed the features of “determining a time period of the entire peristaltic cycle before performing steps (b)-(d)” on the basis of the aforementioned at least implicit descriptions. Thus, the original specification satisfies the written description requirement. Appeal Br. 10. 7 Johnston et al., US 2013/0023714 Al, published Jan. 24, 2013 (“Johnston”). 8 Doyle, US 2010/0297026 Al, published Nov. 25, 2010 (“Doyle”). 9 Bikram, US 2009/0148387 Al, published June 11, 2009 (“Bikram”). 4 Appeal 2016-007351 Application 13/883,603 Principles of Law “The ‘written description’ requirement. . . serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. . . . The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). “(1) [EJxamples are not necessary to support the adequacy of a written description [;] (2) the written description standard may be met. . . even when actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure.” Falknerv. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). Analysis Appellants have the better position. The Specification describes the invention, particularly the concept of a peristaltic cycle, in a manner that one skilled in the art would understand that Applicants were in possession of the invention as claimed. Spec. 17. The Examiner’s reliance on the lack of examples is unwarranted. Based on the record here, there is no requirement that the Specification must contain examples to satisfy the written description requirement. 5 Appeal 2016-007351 Application 13/883,603 Conclusion We conclude that the evidence of record does not support the Examiner’s finding that claim 16 fails to comply with the written description requirement. INDEFINITENESS Issue The issue with respect to this rejection is whether the evidence of record supports the Examiner’s conclusion that claims 1—16 are indefinite. The Examiner finds that claims 1—6 and 8—16 are indefinite in that the term peristatic cycle is not defined. Final Act. 3. The Examiner also finds that claim 6 is indefinite in that the term examining the colon does not appear to be different from imaging the colon. Id. With respect to claim 7, the Examiner finds that the term “free of components which enhance the excretion of the magnetic particle” is indefinite in that the Specification gives no examples of such components. Ans. 6. Appellants contend the claims are not indefinite in that one skilled in the art would understand how to determine the length of a patient’s peristaltic cycle. Appeal Br. 15. With respect to Claim 6, Appellants argue that the term examining is well understood in the art and encompasses more than merely imaging the colon but includes such activities as reviewing such images. Appeal Br. 16. Turning to claim 7, Appellants argue that one skilled in the art would understand what food stuffs would enhance excretion of the particles. Reply Br. 10. 6 Appeal 2016-007351 Application 13/883,603 Principles of Law “[I]t is well-established that the determination whether a claim is invalid as indefinite ‘depends on whether those skilled in the art would understand the scope of the claim when the claim is read in light of the specification.’” Atmel Corp. v. Information Storage Devices Inc., 198 F.3d 1374, 1378 (Fed. Cir. 1999) (quoting North Am. Vaccine, Inc. v. American Cyanamid Co., 7 F.3d 1571, 1579 (Fed. Cir. 1993)). Analysis Again, Appellants have the better position. The Specification clearly defines what is meant by the peristaltic cycle. Spec. 17. In addition, the Specification gives examples as to how the peristaltic cycle can be varied. Spec. 18. We agree with Appellants that one skilled in the art, reading the Specification, would understand the term peristaltic cycle and know how to measure it and control it. Appeal Br. 14, Reply Br. 7. The Examiner points to the lack of examples to support the conclusion of indefmiteness. Ans. 6. We are unpersuaded. The presence or absence of examples is not determinative of definiteness. The issue is whether one skilled in the art would be able to understand and determine the scope of the claims. For the reasons stated above, we agree with Appellants that it does. Appeal Br. 14, Reply Br. 7. Turning to claim 6, we agree with Appellants that one skilled in the art would understand the term “examining” to include both imaging a section of the colon and then reviewing the images. Reply Br. 8. This interpretation is reasonable when read in light of the Specification. See, 7 Appeal 2016-007351 Application 13/883,603 Spec. 8 (screening refers to analytical or visual examination of the colon), Spec. 24 (screening, i.e., examination). With respect to claim 7, we agree with Appellants that one skilled in the art would understand what is meant by the term “free of components which enhance the excretion of the magnetic particle.” Reply Br. 10. Foodstuffs which enhance or promote bowel movements are well known in the art and the Specification specifically teaches against using them. Spec. 23. The Examiner has not pointed to any evidence to support a conclusion otherwise. Conclusion of Law We conclude that the evidence of record does not support the Examiner’s conclusion that claims 1—16 are indefinite. ANTICIPATION Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s finding that claim 7 is anticipated by Boeve. The Examiner finds that Boeve discloses a magnetic particle which is coated to be gastroresistant and comprises iron oxide. Final Act. 3. The Examiner finds that since Boeve is silent as to components which enhance excretion of the particles, such components must be absent. Final Act. 4. Appellants argue that while Boeve discloses administering the magnetic particles in food or drink, Boeve does not teach that the food must be free of components which enhance the excretion of the particles. Appeal 8 Appeal 2016-007351 Application 13/883,603 Br. 18—19. Appellants contend that the food of Boeve may or may not contain components which enhance excretion of the particles. Appeal Br. 19. Appellants also contend that Boeve does not teach the limitation “configured ‘for in vivo screening for cancerous diseases of the colon.’” Id. Principles of Law “A reference may anticipate inherently if a claim limitation that is not expressly disclosed ‘is necessarily present, or inherent, in the single anticipating reference.’ The inherent result must inevitably result from the disclosed steps; ‘[ijnherency . . . may not be established by probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379—80 (Fed. Cir. 2012) (citations omitted, alterations in original). “[T]he examiner must provide some evidence or scientific reasoning to establish the reasonableness of the examiner’s belief that the functional limitation is an inherent characteristic of the prior art” before the burden is shifted to Applicants to disprove the inherency. Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986). Analysis Appellants have the better position. While Boeve teaches that the magnetic particles can be administered with food, Boeve is silent as to the composition of the food. Boeve 9,11. 8—14. As Appellants point out, it was well known in the art that certain foodstuffs can enhance excretion. Reply Br. 10. Thus the food referenced in Boeve may or may not contain components which enhance excretion. Appeal Br. 19. 9 Appeal 2016-007351 Application 13/883,603 The Examiner contends that since Boeve is silent as to the presence of excretion-enhancing components, such components must be absent. Ans. 6. We are unpersuaded. It is the Examiner’s burden to provide evidence or sufficient reasoning that supports the proposition that excretion enhancing components are necessarily absent. Ex parte Skinner, 2 USPQ2d at 1789. Here that Examiner has not pointed to any sufficient evidence or scientific reasoning to support the proposition that excretion enhancing components are necessarily absent in the foods used in Boeve. Conclusion We conclude that a preponderance of the evidence does not support the Examiner’s finding that claim 7 is anticipated by Boeve. OBVIOUSNESS Issue Both rejections under 35 U.S.C. § 103(a) rely on the same primary reference, Boeve, and the arguments presented by Appellants and the Examiner are the same. Therefore, we treat the rejections together. The issue with respect to these rejections is whether a preponderance of the evidence supports the Examiner’s conclusion that the rejected claims would have been obvious over Boeve combined with Horn, Geiger, or Loewke; or Boeve combined with Horn, Geiger, or Loewke in further view of Johnson, Doyle, or Bikram. The Examiner finds that Boeve teaches: a method for collecting data by using Magnetic Particle Imaging comprising the steps of: (a) delivering magnetic particles to a colon of a patient; (b) generating an imaging 10 Appeal 2016-007351 Application 13/883,603 magnetic field with a spatial distribution of the magnetic field strength such that an area of examination in the colon consists of a first sub-area of the colon with lower magnetic field strength, where the magnetization of a magnetic particle which were pre-delivered to the colon is not saturated, and a second sub-area of the colon with a higher magnetic field strength, where the magnetization of said magnetic particle is saturated; (c) changing the spatial location of both sub-areas in the area of examination so that the magnetization of said particles changes locally; and (d) acquiring signals that depend on the magnetization in the area of examination influenced by this change, wherein the area of examination in the colon comprises a portion or segment of the colon. Final Act. 4—5. The Examiner acknowledges that Boeve is silent as to the duration of the examination, but finds that determination of the optimum duration would have been an obvious design choice. Final Act. 5. Appellants contend that Boeve is silent as to performing the examination during an entire peristaltic cycle or during any other biological process. Appeal Br. 23. Appellants argue that Boeve is directed to an entirely different process and would not lead one skilled in the art to optimize the process for examination of the colon. Reply Br. 14. 11 Appeal 2016-007351 Application 13/883,603 Principles of Law “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citation omitted). “Even when obviousness is based on a single prior art reference, there must be a showing of a suggestion or motivation to modify the teachings of that reference.” In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1316-17 (Fed. Cir. 2000) (citation omitted). Analysis Once again we find that Appellants have the better position. As the Examiner acknowledges, Boeve is completely silent as to conducting the claimed steps of (a)-(d) of the examination during an entire peristaltic cycle of a patient. Final Act. 5. In addition, while Boeve discusses applying the described method to the intestinal tract, Boeve does not tie the imaging process to any biological function. Appeal Br. 23. The Examiner argues that conducting the claimed steps during an entire peristaltic cycle would have been obvious as matter of design choice. Final Act. 5. We are unpersuaded. The burden is on the Examiner to articulate a motivation to modify the method of Boeve to arrive at the claimed method. Here the Examiner has not given a reason why one skilled in the art would modify Boeve as suggested by the Examiner. This is especially true as the method of Boeve is not directed to colon screening or conducting an examination during any particular biological process, but to 12 Appeal 2016-007351 Application 13/883,603 imaging an unspecified body region and to using the magnetic particles to heat a region in the body. Boeve 1. Conclusion of Law We conclude that a preponderance of the evidence does not support the Examiner’s conclusion that claims 1—6 and 8—16 would have been obvious over Boeve combined with (i) Horn, Geiger, or Loewke, or (ii) Boeve combined with Horn, Geiger, or Loewke, in further view of Johnson, Doyle, or Bikram. SUMMARY We reverse the rejection under 35U.S.C. § 112, first paragraph. We reverse the rejections under 35U.S.C. § 112, second paragraph. We reverse the rejection under 35 U.S.C. § 102(b). We reverse the rejections under 35 U.S.C. § 103(a). REVERSED 13 Copy with citationCopy as parenthetical citation