Ex Parte Paul et alDownload PDFPatent Trial and Appeal BoardDec 29, 201612744201 (P.T.A.B. Dec. 29, 2016) 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. 12/744,201 05/21/2010 Saurav Paul 0B-053602US 9848 (065513-0731) 67337 7590 01/03/2017 DYKEMA GOSSETT PLLC (STJ) 4000 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402 EXAMINER GUPTA, VANI ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 01/03/2017 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): MN_IPMail @ dykema. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SAURAV PAUL and ISRAEL BYRD Appeal 2015-002451 Application 12/744,201 Technology Center 3700 Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A. POLLOCK, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL This is a decision on appeal1 under 35 U.S.C. § 134(a) from the Examiner’s rejection of claims 1—5, 7, 8, 10, 11, 18, 19, 20, 22, 23, 36, and 47. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as St. Jude Medical, Atrial Fibrillation Division, Inc. (App. Br. 1). Appeal 2015-002451 Application 12/744,201 STATEMENT OF THE CASE Claim 1 is representative of the claims on appeal and reads as follows 1. A system for diagnosis or treatment of a tissue in a body, comprising: a deformable, tubular body defining a proximal end and a distal end; a first optic fiber disposed within said tubular body extending from said proximal end to said distal end of said body; a first electromagnetic radiation source located at or near said proximal end; an electromagnetic radiation sensor located at or near said proximal end; and an electronic control unit configured to: selectively activate said first electromagnetic radiation source to direct a first set of electromagnetic radiation through said first optic fiber to said tissue, said tissue containing a first substance introduced into said tissue that alters radiation characteristics of said tissue; receive a signal generated by said electromagnetic radiation sensor in response to a second set of electromagnetic radiation received through one of said first optic fiber and a second optic fiber disposed within and extending from said proximal end to said distal end of said tubular body, said second set of electromagnetic radiation originating from said tissue in response to said first set of electromagnetic radiation as altered by said first substance; and determine a first characteristic of said tissue responsive to said signal, wherein said first characteristic includes at least a stage of necrosis of a region of interest in said tissue; and a focusing lens disposed in one of (i) a distal end of said first optic fiber configured to focus said first set of electromagnetic radiation and (ii) a distal end of said second optic fiber configured to focus said second set of electromagnetic radiation. (App. Br. 13; Claims Appendix.) 2 Appeal 2015-002451 Application 12/744,201 Issue The Examiner has rejected claims 1—5, 7, 8, 10, 11, 18, 19, 20, 22, 23, 36, and 47 under 35 U.S.C. § 103(a) as obvious in view of Benaron2 and Ryan3 (Ans. 2—10). The issue: Does the preponderance of evidence of record support the Examiner’s conclusion that the combination of Benaron and Ryan would have made obvious a system for tissue diagnosis or treatment comprising an electronic control unit that is configured to identify a stage of necrosis in a tissue based on “electromagnetic radiation originating from said tissue in response to said first set of electromagnetic radiation as altered by said first substance,” as required by claim 1 Findings of Fact We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art as set out in the Answer and Final Action. For emphasis only we highlight the following: 1. Benaron teaches a tool for nondestructive interrogation of tissue including a light source emitter and detector (Benaron, Abstract). 2. Benaron teaches that the tool includes “one or more optical emitting windows through which light emitted by a light source is launchedt_- t_- c,- J c,- to illuminate tissue, and one or more optical detecting windows through which the light illumination in response to the launched emitted light is coupled and detected or sensed by a light detector” (Benaron, col. 4,11. 46 51). 2 David A. Benaron et al., US 5,807,261, Sept. 15, 1998 (“Benaron”). 3 S. Eric Ryan, US 2008/0125634 Al, May 29, 2008 (“Ryan”). 3 Appeal 2015-002451 Application 12/744,201 3. Benaron teaches that “[t]he emitted light may be at one or more discrete wavelengths or a broadband light source or a combination” thereof (Benaron, col. 4,11. 51—54). 4. Benaron discloses that “each given tissue type has a range of spectral characteristics that is identifiably different from the ranges of the other tissue types” (Benaron, col. 7,11. 40-42). This permits obtaining spectral characteristics over a broad spectrum for different tissues, selecting certain ones of discrete wavelengths from the spectrum, by which the tissue structures and tissue types of interest differ, and classifying tissue types by [the] selected ranges of spectral characteristics that are unique fertile different tissue types, e.g,, for bile duet, urine containing structures, blood containing structures (arterial and venous), lymph containing structure, nerve tissue, muscle, fat, tissue exudate, inflammatory substances, drugs, toxins, metabolites, tumors, organs, air, water and other body components. (Benaron, col. 7,11. 42—53.) 5. Benaron discloses that, in one embodiment, “fluorescently tagged monoclonal antibodies selectively absorbed by particular tissue structures can be used to locate that: tissue based on the fluorescent: property” (Benaron, col. 7,11. 53—56). “j’Tjhe introduction of fluids having unique spectral characteristics into a tissue structure, e.g., a gastrointestinal duct, or a kidney, also can be considered in identifying such tissue or structure” (Benaron, col. 7,!!. 56—59). “Radioisotopes, chemiluminescent, electrochemilumineseent and magnetizable particulate tags that are selectively absorbed or adsorbed can be similarly used” (Benaron, col. 7,11. 59-62). 6. Benaron teaches that although the spectra for a particular tissue type will vary from one person to another and from one location to another, 4 Appeal 2015-002451 Application 12/744,201 "‘a set of spectxa can be selected which permit a wide variation from person to person . , . [but wherein] transmission spectra ranges for the different tissue types are sufficiently and clearly distinct” (Benaron, col. 15,11. 21— 26), “This enables the interrogation tool 10 . . . to discriminate and identify many different major tissue types” (Renaron, col, 15,11, 26-28). 7. Benaron teaches that a library of tissue types based on transmission spectra can be created (Benaron, col. 15,11. 57 59). “The library also can include a set of spectra records corresponding to different pathological states of a selected tissue class, such as normal, precancerous, and cancerous states of a given tissue class, e.g., pancreas, liver, lung, or more than one given tissue” (Renaron, col. 15,11. 60-64). 8. Benaron teaches that, in one embodiment, a “camera captures an image of the field which is stored as pixels in a memory array” and the “paged memory can be analyzed by a computer to yield c[o]lorimetric information about each pixel of the image. The colorimetric information can be further analyzed for spectral fingerprints of various tissue qualities, e.g., bloodvessels or ureters” (Benaron, col 27,11. 12—22), 9. Benaron teaches that the “colorimetry technique can be used to identify areas of endometriosis . . . a.l characteristics of normal tissue and the endometriosis can be . . . used to decide whether the tissue being interrogated is normal or abnormal. . . [and] to determine when the endometriosis has been effectively removed” (Benaron, col. 28,11. 18—26). “In bowel surgery, an optical probe can be similarly used to identify obstructions or inflamed tissue beds” (Benaron, col. 28,!!. 27—28). “Similarly, in cancer surgery ... a pathological tissue classification can be 5 Appeal 2015-002451 Application 12/744,201 used to distinguish cancerous tissue from noneaneerous and other types of healthy tissue” (Benaron, col. 28,11. 28 33). 10. Ryan teaches an apparatus that “includes a catheterized optical probe connected to a spectroscopic analysis system programmed to identify (in vivo) and accurately locate infarcted myocardial tissue and various types of surrounding tissue affected by the infarction'’ (Ryan, f 10). “The catheter further includes an integrated treatment system which . . . can be accurately positioned . . . [for] treatment delivery to affected areas surrounding necrotic tissue (e.g. periinfarct areas)” (Ryan, f 10). “[T]he treatment system , . . inject[s] various compounds and/or therapeutic agents (e.g. stem cells, gene etc.) intended for aiding in the regeneration of necrotic tissue and/or revitalization of affected surrounding tissue” (Ryan, f 10). 11. Ryan teaches that the“ability to identify myocardial infarcts is dependent upon the time that has elapsed since the ischemic event took place” (Ryan, 63). “Infarcts resulting in sudden cardiac death and are less than 12 hours old are usually not apparent upon gross examination . . . Changes during this time period are histochemica! and require adjunctive staining to identi fy the affected area of necrosis” (Ryan, f 63). “After 24 hours, however, pallor is often grossly present due to stagnated blood within the lesion” (Ryan, % 63). 12. Ryan teaches that, in absorbance spectrum analysis, “[p jeak regions associated with necrotic tissue . . . that are not generally present or directly associated with normal myocardium, can be detected and analyzed to distinguish, characterize, and locate an infarct region” (Ryan, f 92). “Peak regions associated with calcified and fibrous tissue . . . and locate surrounding tissue affected by an infarct” (Ryan, f 92). 6 Appeal 2015-002451 Application 12/744,201 13. Ryan teaches that in order to “position the catheter for providing treatment, spectroscopic analysis can also distinguish the types and conditions of tissue within and surrounding a heart, including three major diseased states associated with myocardial infarct: necrotic tissue, calcified tissue, and fibrous tissue” (Ryan, % 99). “[TJhe tissue can be characterized as being normal myocardial tissue, affected tissue surrounding a myocardial infarct region (edema inflammatory zone), fibrosis, and/or necrotic or calcified myocardial infarct lesions” (Ryan, f 99). “Spectral analysis reflecting high degrees of e[]dema content and/or inflammation indicate a region of tissue surrounding infarcted or necrotic tissue” (Ryan, 14. Ryan teaches that the identification of “fibrous or calcified tissue can often help identify the center of a myocardial infarct region, which can be surrounded by fibrous or calcified tissue” (Ryan, f 103). “Data about tissue and blood, including oxygenation content and pH, is also obtainable using known spectroscopic analysis techniques and is useful for aiding [the] diagnosis” (Ryan, 1103). “Analysis of oxygenation can be used in part to help assess whether myocardial tissue is damaged (e.g. necrotic) or normal • ■ • [by] characterizing spectra obtained from oxy and deoxy-hemoglobin” (Ryan, ff 103). “Collagen levels can also be measured to aid in the comparison of fibrous tissue associated with necrosis and normal (relatively collagen-free) tissue” (Ryan, f 103). 7 Appeal 2015-002451 Application 12/744,201 Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results,” KSR Ini 7 Co. v. Tele/lex Inc., 550 U.S. 398, 416 (2007). If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, 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. It is proper to “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. See also id. at 421 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”). Analysis The Examiner finds that Benaron discloses a system for “diagnosis or treatment of a tissue in a body” (Ans. 2) that comprises most of the components of claim 1, including “a first electromagnetic radiation source . . . [and] an electromagnetic radiation sensor” at or near the proximal end (Ans. 3). The Examiner finds that Benaron also suggests “an electronic control unit (22). . . [that] activate[s] said first electromagnetic radiation source to direct a first set of electromagnetic radiation through . . . fiber optic fiber[s] ... to said tissue,” wherein the tissue contains an introduced substance (Ans. 3). The Examiner finds that Benaron discloses that “radioisotopes, chemiluminescent, electrochemiluminescent and 8 Appeal 2015-002451 Application 12/744,201 magnetizable particulate tags that are selectively absorbed or adsorbed into the tissue affect[] the tissue so that it may be located based on the fluorescent property of the affected tissue” (id. at 4). The Examiner finds that Benaron discloses introduced substances “may have spectral characteristics that, when introduced into the tissue structure may affect the tissue in a way so that it is identifiable by its unique spectral characteristics” (id.). The Examiner finds that Benaron discloses “identifying diseased, or abnormal or unhealthy, tissue per the spectral characteristics collected” (id. at 5). The Examiner acknowledges that Benaron does not disclose determining a stage of necrosis of a tissue but finds that Ryan discloses the use of spectral analysis to characterize tissue “as being normal tissue or necrotic tissue” (id.). The Examiner concludes that it would have been obvious to one of ordinary skill in the art to modify Benaron’s systems “for identifying diseased tissue with Ryan’s teachings of qualifying diseased tissue as necrotic ... [to identify] healthy tissue and less healthy tissue, and therefore provide treatment or surgery with optimal results by avoiding tissues that are comparably healthier” (id. at 6). Appellants argue that Benaron “discloses identifying a tissue type via use of an introduced substance,” but does not disclose identifying a tissue condition, particularly a stage of necrosis, using an introduced substance (App. Br. 7; see Reply Br. 3). Appellants’ arguments are not persuasive. Benaron generally discloses that spectroscopic analysis may be used to determine tissue types and tissue conditions (FFs 1—3). That is, Benaron discloses that spectroscopic analysis may be used to identify tissue types such as blood 9 Appeal 2015-002451 Application 12/744,201 vessels, lymph containing structures, and internal organs, and may be used to identify tissues conditions such as inflamed tissue, diseased tissue, pathological tissue, precancerous tissue, and cancerous tissue (FFs 4, 6, 7, and 9). Although Benaron discloses, in one embodiment, that a colorimetric technique can be used to identify tissue conditions, Benaron also discloses that the colorimetric technique can be used in conjunction with spectral analysis (FF 8). Additionally, Benaron also generally discloses that introduced substances such as drugs, fluorescently tagged monoclonal antibodies, radioisotopes, and chemiluminescent tags may be used in conjunction with a spectroscopic analysis (FF 5). Thus, one of ordinary skill in the art would have understood Benaron to suggest that spectroscopic analysis that uses introduced substances could be used to identify both tissue types and tissue conditions, i.e. inflamed tissues and diseased tissue (see Ans. 12-13). Appellants argue that Benaron, as modified by Ryan, “does not disclose determining a tissue characteristic (stage of necrosis) responsive to a signal that is based on sensed electromagnetic radiation originating from the tissue altered by an introduced substance” (App. Br. 9, (emphasis removed)). Appellants argue that Ryan does not cure the deficiencies of Benaron because Ryan “does not disclose or suggest identifying a tissue condition (i.e., stage of necrosis) based on an introduced substance” (App. Br. 9). Appellants’ arguments are not persuasive. Ryan discloses a spectroscopic method and apparatus for identifying and treating tissues affected by myocardial infarct (FFs 10—13). Ryan discloses the use of spectroscopy to analyze tissue characteristics such as chemical, blood, and 10 Appeal 2015-002451 Application 12/744,201 oxygen content, in order to locate tissues affected by myocardial infarct (FF 14) for the purposes of treatment. Ryan discloses that, with spectral analysis, tissue can be characterized as normal myocardial tissue, affected tissue surrounding a myocardial infarct region, i.e. a zone with inflammation and edema inflammatory zone, and necrotic or calcified infarct lesions (FFs 13 and 14). Ryan discloses that infarcts that are less than 12 hours old show only histochemical changes and require adjunctive staining to identify the necrosis (FF 11). Although Ryan does not specifically disclose that necrotic lesions are identified using an introduced substance and spectroscopic analysis, it would have been obvious to one of ordinary skill in the art to use an introduced substance for spectroscopic analysis of tissue, as disclosed by Benaron, to identify necrotic tissue. In particular, Ryan discloses that early infarct lesions require histochemical staining for identification and it would have been obvious to use added substances for the purpose of identifying early infarct lesions (FF 11). Appellants argue that Benaron discloses that “the radioisotopes, chemiluminescent, electroluminescent and magnetizable particulate tags are selectively absorbed or adsorbed into tissue, and may affect the tissue in a way so that it is identifiable by its unique spectral characteristics” (App. Br. 10). Appellants argue that “one of ordinary skill in the art would expect that the substances . . . [would] affect a particular tissue type in the same way regardless of the stage of necrosis” (App. Br. 10-11). Appellants’ arguments are not persuasive. As discussed above, Ryan discloses that early myocardial infarct lesions can be identified with histochemical staining and that necrotic tissue differs from normal myocardial tissue in terms of fibrosis and calcification. Thus, one of 11 Appeal 2015-002451 Application 12/744,201 ordinary skill the art would expect that added substances could be used to identify conditions within tissue, i.e. necrotic tissue and myocardial tissue affected by an infarct, as well as for identifying different tissue types. The evidence of record supports the Examiner’s conclusion that the combination of Benaron and Ryan would have made obvious a system for diagnosis or treatment of a tissue in a body as recited in claim 1. Accordingly, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a). SUMMARY We affirm the rejection of claim 1 under 35 U.S.C. § 103(a). Claims 2—5, 7, 8, 10, 11, 18, 19, 20, 22, 23, 36, and 47 have not been argued separately and therefore fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). 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 12 Copy with citationCopy as parenthetical citation