Ex Parte Ehman

Patent Trial and Appeal BoardJul 14, 2016

12990859 (P.T.A.B. Jul. 14, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/990,859 11/03/2010 26710 7590 07118/2016 QUARLES & BRADYLLP Attn: IP Docket 411 E. WISCONSIN A VENUE SUITE 2350 MILWAUKEE, WI 53202-4426 FIRST NAMED INVENTOR Richard L. Ehman 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. 630666.00271 3870 EXAMINER SMITH, RUTHS ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 07/18/2016 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): pat-dept@quarles.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RICHARD L. EHMAN Appeal2014-005995 Application 12/990,859 Technology Center 3700 Before EDWARD A. BROWN, GEORGE R. HOSKINS, and ARTHUR M. PESLAK, Administrative Patent Judges. HOSKINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Richard L. Ehman ("Appellant") 1 appeals under 35 U.S.C. Â§ 134 from the Examiner's decision rejecting claims 1, 4--13, and 17 in this application. The Board has jurisdiction over the appeal under 35 U.S.C. Â§ 6(b). We AFFIRM. 1 The Appeal Brief identifies Mayo Foundation for Medical Education and Research as the real party in interest. Appeal Br. 1. Appeal2014-005995 Application 12/990,859 CLAIMED SUBJECT MATTER Claim 1 is the sole independent claim on appeal, and it recites: 1. A method for generating a report of a predicted, future potential for disease incidence in a subject, the steps compnsmg: a) performing a first in vivo measurement of a mechanical property of tissues of the subject to determine a first value of stiffness of the tissues of the subject wherein the tissues examined appears to be normal in appearance; b) performing a second in vivo measurement of a mechanical property of tissues of the subject to determine a second value of stiffness of the tissues of the subject, wherein the second in vivo measurement is performed under different conditions from the first in vivo measurement; c) comparing the first value and the second value to determine a change value and correlating at least one of the first value, the second value, and the change value with a normal subject to probe deviations of the at least one of the first value, the second value, and the change value from the normal subject; and d) generating a report based on step c) indicating future potential for disease incidence in the tissues. Appeal Br. A-1 (Claims App.). REJECTIONS ON APPEAL Claims 1, 4--13, and 17 stand rejected under 35 U.S.C. Â§ 112, first paragraph, for lack of written description. Claims 1, 4--13, and 17 stand rejected under 35 U.S.C. Â§ 112, second paragraph, as indefinite. 2 Appeal2014-005995 Application 12/990,859 Claims 1, 4--11, 13, and 17 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over a Manduca Article2 alone or in combination with Ehman (US 2006/0264736 Al, pub. Nov. 23, 2006) and Zara (US 2009/0116032 Al, pub. May 7, 2009). Claim 12 stands rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the Manduca Article alone or in combination with Ehman and Zara, and further in view of Smith3 and Biagini4. ANALYSIS A. Written Description and Indefiniteness Rejections All claims on appeal (claims 1, 4--13, and 17) stand rejected under 35 U.S.C. Â§ 112, first paragraph, for lack of written description, on the basis that the originally-filed Specification "fails to disclose that the tissue examined appears to be normal in appearance." Final Act. 2. All claims on appeal also stand rejected under 35 U.S.C. Â§ 112, second paragraph, as being indefinite, on the basis that "[i]n claim 1 it is unclear as to how the tissue is visualized for determining it is 'normal in appearance'." Id. at 2-3. Appellant does not address eitherÂ§ 112 rejection in the Appeal Brief. See Appeal Br. i (Table of Contents), 4. We, therefore, summarily sustain bothÂ§ 112 rejections of claims 1, 4--13, and 17. See MPEP Â§ 1215.03 ("An appellant may, of course, choose not to present arguments or rely upon 2 Armando Manduca, Dynamic Magnetic Resonance Elastography, Mayo Clinic College of Medicine (May 2006). 3 Michael Smith, Imaging May Lessen Liver Biopsies to Diagnose Fibrosis, MEDPAGE TODAY (Oct. 2007), http://www.medpagetoday.com/ InfectiousDisease/Hepatitis/6866 (accessed Oct. 25, 2012). 4 G. Biagini & G. Ballardini, Liver Fibrosis and Extracellular Matrix, 8 J. HEPATOL. 115-24 (Jan. 1989), Abstract. 3 Appeal2014-005995 Application 12/990,859 particular evidence as to certain claim rejections; however, such arguments and evidence are waived for purposes of the appeal and the Board may summarily sustain any grounds of rejections not argued."). B. Obviousness based on the Manduca Article, alone or in combination with Ehman and Zara Claims 1, 9-11, and 13 In rejecting claim 1, the Examiner cites the Manduca Article, Section 6 ("Applications"), as disclosing a method of measuring tissue stiffness using magnetic resonance elastography (MRE) (claim 1, step a)), and reporting an image of the tissue in a color-coded fashion to show where an elevated stiffness indicates disease causing tissue is located. Final Act. 3. The Examiner finds Manduca Section 6 does not disclose comparing first and second measurements of tissue stiffness under different conditions (claim 1, steps b }-c) ), or "indicating future potential for disease incidence" (claim 1, step d)). Id. at 3--4. The Examiner determines it would have been obvious to modify the Manduca Section 6 MRE imaging to include such steps, in light of other disclosures in the Manduca Article, or in light of Ehman and Zara. Id. Concerning comparing first and second measurements of tissue stiffness under different conditions, the Examiner finds the Manduca Article discloses "ultrasound elasticity imaging involves obtaining images with and without compression applied"-that is, under different conditions. Final Act. 3 (emphasis added); Ans. 6; see Manduca Article, Â§ 3 ("Elasticity Imaging Techniques"), i-f 1. The Examiner further finds Ehman discloses MRE imaging of elastic properties of tissue, "where two images are acquired under different conditions and the difference is used to analyze the tissue." 4 Appeal2014-005995 Application 12/990,859 Final Act. 3 (citing Ehman, Fig. 5, iii! 44--46); Ans. 6. The Examiner determines, in light of those disclosures, it would have been obvious to modify the Manduca Section 6 MRE imaging "such that two sets of data are acquired under different conditions as such is a well-known expedient in the art for analyzing elastography images." Final Act. 3. Appellant argues the Manduca Article fails to disclose or suggest comparing first and second measurements of tissue stiffness under different conditions. Appeal Br. 6-7. Appellant contends the Manduca Article teaches "using only one MRE data acquisition that is then compared to pre-determined mechanical properties of a 'normal tissue' and a 'breast cancer tissue."' Id. at 7 (citing Manduca Section 6) (emphasis added). Appellant argues Ehman does not change that failing of the Manduca Article, because Ehman uses MRE on a subject's lungs by applying vibrations to the chest wall to reconstruct a shear modulus from the MRE image data. Id. at 12 (citing Ehman, Abstract). Appellant's arguments are not persuasive of Examiner error. As to the Manduca Article, the rejection is not premised on Manduca Section 6 disclosing comparing first and second MRE measurements of tissue stiffness under different conditions. Instead, the rejection is premised on Manduca Section 3 disclosing comparing first and second ultrasound measurements of tissue stiffness under different conditions. Appellant's arguments do not address that finding, or the Examiner's determination that it would have been obvious to apply such a teaching from the ultrasound imaging of Manduca Section 3 to the MRE imaging of Manduca Section 6, as the application of "a well-known expedient in the art for analyzing elastography images." Final Act. 3. 5 Appeal2014-005995 Application 12/990,859 As to Ehman, we are not persuaded a person of ordinary skill in the art would be dissuaded from applying the teachings of Ehman to Manduca Section 6, simply because the former images a subject's lungs whereas the latter images a subject's breast, brain, or liver. Both Ehman and Manduca Section 6 concern MRE imaging of the human body-that is, applying an acoustic palpation actuator to the subject and recording the effects with an MRI imaging apparatus. Ehman i-fi-136, 44; Manduca ArticleÂ§ 4. Given these commonalities, a person of ordinary skill in the art would have known to apply, in a predictable manner, Ehman's teachings of comparing first and second measurements of tissue stiffness under different conditions (with and without palpation) to the MRE imaging method ofManduca Section 6. See Ehman i1 44. Appellant does not challenge the Examiner's reason for this combination, which is the application of "a well-known expedient in the art for analyzing elastography images." Final Act. 3. Concerning the claimed indicating future potential for disease incidence, the Examiner finds the Manduca Article, Section 1 ("Introduction"), "discloses that precancerous tissue changes are associated with mechanical properties." Final Act. 3--4. The Examiner further finds Zara discloses "elastographic imaging including imaging displacement of the tissue to infer mechanical properties which may be indicative of ... precancerous conditions ... indicative of future potential for disease incidence such as cancer[]." Id. at 4 (citing Zara i132). The Examiner determines, in light of those disclosures, it would have been obvious to modify the Manduca Section 6 MRE imaging to determine the presence of precancerous tissue which can lead to cancer if not treated. Id. 6 Appeal2014-005995 Application 12/990,859 Appellant argues Manduca Section 1 fails to disclose or suggest generating a report indicating future potential for disease incidence. Appeal Br. 6-8. According to Appellant, the Manduca Article discloses using MRE "in tumor detection, disease characterization, and other applications," but not in "predict[ing] a future potential disease condition." Id. at 6. Appellant acknowledges Manduca Section 1 states: "Research has also suggested that pre-cancerous tissue changes are associated with alterations in mechanical properties" of the tissue. Manduca Article Â§ 1 (citations omitted) (emphasis added); Appeal Br. 7. Appellant relies on the Manduca Declaration5 as establishing "one of ordinary skill in the art will readily understand that so- called 'pre-cancerous' tissue is, in fact, diseased tissue, as it reflects early, but actual presence of cancer cells." Appeal Br. 7 (citing Manduca Deel. ,-r 7). The Manduca Declaration states the term "pre-cancerous" in Manduca Section 1 "was in reference to a well-known breast condition known as 'ductal carcinoma in situ."' Manduca Deel. ,-r 7 (underlining removed). The Examiner does not address the Manduca Declaration in the Final Office Action. See Final Act. 2-5. In an Advisory Action and the Answer, the Examiner states the Manduca Declaration will not be entered because it was not timely filed before the Appeal Brief on January 21, 2014. Adv. Act. (mailed Feb. 25, 2014) (citing 37 C.F.R. Â§ 41.33(d)(2)); Ans. 6. However, the record establishes Appellant filed the Manduca Declaration with a Request for Continued Examination on March 13, 2013. See Reply Br. 2-3. 5 See Appeal Br. (Evidence App.), Declaration Under Rule 1.132 of Armando Manduca, dated March 12, 2013. 7 Appeal2014-005995 Application 12/990,859 Indeed, in the succeeding Non-Final Office Action, the Examiner entered the Manduca Declaration, and stated: The [Manduca Declaration] is insufficient . . . because: the interpretation of the claim language and the use of the term "pre-cancerous" is considered to be too narrow .... The finding of pre-cancerous cells clearly provides an indication of a future disease state. Non-Final Office Action (mailed June 28, 2013), 2 and 4. Thus, we determine the Manduca Declaration is properly before us as part of the record on appeal. We agree with the Examiner, however, that the Manduca Declaration's interpretation of the term "pre-cancerous" in Manduca Section 1 is too narrow. Dr. Manduca's conclusory statement that "pre- cancerous" actually means "diseased tissue, as it reflects early, but actual presence of cancer cells" (Manduca Deel. i-f 7) is not supported by citation to other disclosures in the Manduca Article or other evidence of record. The notion that "pre-cancerous" is synonymous with "actual presence of cancer cells" seems to be erroneous upon initial consideration, and requires more support in order to be persuasive. Similarly, Dr. Manduca's explanation that "pre-cancerous" in Manduca Section 1 refers to "ductal carcinoma in situ" is unsupported by citation to other evidence in the record. Perhaps the"[ 4, 5]" Sarvazyan and Burke et al. articles cited in Manduca Section 1 would shed light on these issues, but those articles do not appear to be in the record of the present application. See Manduca Article,Â§ 1 & REFERENCES. For these reasons, we are not persuaded by Dr. Manduca's explanation of the meaning of "pre-cancerous" in Manduca Section 1. 8 Appeal2014-005995 Application 12/990,859 Further, even if Dr. Manduca's explanation were persuasive, the Examiner also relies on Zara in relation to the claimed "indicating future potential for disease incidence." Final Act. 4. Appellant responds: "Appellant fails to see how Zara, which is specifically directed to [optical coherence tomography (OCT)], could be combined with Manduca [Section 6] and Ehman, which are directed to MRE." Appeal Br. 12. Appellant contends the Examiner's combination would improperly change the MRE principle of operation of Manduca Section 6. Id. According to Appellant, "although Zara indicated that OCT imaging may be used to image the displacements of the tissues to infer mechanical properties which may be indicative of, for example, ... precancerous conditions," Zara fails to disclose any further steps "such as claimed" to predict a future potential disease condition. Id. We are not persuaded that the Examiner errs in relying on Zara. While Zara gathers data using OCT rather than MRI, both imaging methods apply an acoustic palpation actuator to the subject in order to generate imaging data of interest. Zara i-f 32; Manduca Article Â§ 4. Appellant does not articulate any reasoning as to why it would not have been predictable for a person of ordinary skill in the art to apply Zara's disclosure of using OCT imaging palpation to diagnose precancerous conditions, to modify the Manduca Section 6 MRE imaging palpation, to diagnose precancerous conditions which can lead to cancer if not treated. Final Act. 4. For the foregoing reasons, we sustain the rejection of claim 1 as unpatentable over the Manduca Article, either alone or in combination with Ehman and Zara. Appellant does not argue for the patentability of claims 9 Appeal2014-005995 Application 12/990,859 9-11 and 13 separately from their common parent claim 1. Appeal Br. 4- 14. Therefore, we likewise sustain the rejection of claims 9-11 and 13. Claims 4-8 Appellant discusses each of claims 4-7 separately from their common parent claim 1. Appeal Br. 8-9, 13. One argument presented is the same as for claim 1, namely, the Manduca Article does not provide for comparing first and second measured stiffness measured under different conditions "because, at best, [the Manduca Article] only contemplates one in vivo measurement and does not teach comparisons re la ti ve to two measurements of normal-appearing tissue." Id. at 8-9. This argument is not persuasive for the reasons provided above. Appellant also discusses the limitations in these claims directed to calculating stiffness values "at each image pixel" (claims 4 and 5), "comparing each image pixel" (claim 6), and displaying an image indicating "which pixel locations" have a value deviating from normal (claim 7). Appeal Br. 8-9, 13 (emphases added to claim limitations). We are not persuaded of Examiner error in these regards, because we agree with the Examiner's finding that the Manduca Article "disclose[s] providing values of stiffness at each pixel." Ans. 6 (citing Manduca Article, Â§ 4); see also Manduca Article, Â§ 6, Figs. 4-5 (pixelated images of breast tissue produced byMRE). Thus, we sustain the rejection of claims 4-7 as unpatentable over the Manduca Article, either alone or in combination with Ehman and Zara. Appellant does not argue for the patentability of claim 8 separately from its 10 Appeal2014-005995 Application 12/990,859 parent claim 7. Appeal Br. 4-14. Therefore, we likewise sustain the rejection of claim 8. Claim 17 Appellant discusses claim 17 separately from its parent claim 1. Appeal Br. 9, 13-14. Claim 17 recites step a) of claim 1 "includes performing the first in vivo measurement after the subject has been fasting," and step b) of claim 1 "includes providing a sugar solution to the subject for ingestion prior to performing the second in vivo measurement." Id. at A-4 (Claims App.). The Examiner reasons "in the absence of any showing of criticality, the manner in which conditions are varied for the two sets of data acquired would have been an obvious design choice based on the type of diagnosis being provided." Final Act. 4. The Examiner further determines "the different conditions would have been an obvious design choice, readily determined to achieve an optimum result, without undue experimentation, based on the type of diagnosis being provided." Ans. 7. Appellant argues: [NJ one of the references teach[ es] or suggest[ s] fasting before the first in vivo measurement and ingesting a sugar solution before the second in vivo measurement as indicated in claim 1 7. Manduca does not even disclose using multiple in vivo measurements from the subject, so it would not make sense for Manduca to disclose different setups for multiple in vivo measurements. Appeal Br. 9, 13-14. This argument is not persuasive of error, because it does not address the design choice rationale of the rejection. Thus, we sustain the rejection of claim 17 as unpatentable over the Manduca Article, either alone or in combination with Ehman and Zara. 11 Appeal2014-005995 Application 12/990,859 C. Obviousness based on the Manduca Article, alone or in combination with Ehman and Zara, and further in view of Smith and Biagini Appellant does not argue the rejection of dependent claim 12 separately from its parent claim 1. See Appeal Br. 4--14. Therefore, for the reasons provided above, we sustain the rejection of claim 12 as unpatentable over the Manduca Article, either alone or in combination with Ehman and Zara, and further in view of Smith and Biagini. DECISION The Examiner's decision to reject claims 1, 4--13, and 17 is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended, under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 12