Ex Parte Clendenen et alDownload PDFPatent Trial and Appeal BoardDec 11, 201714128694 (P.T.A.B. Dec. 11, 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. 14/128,694 02/25/2014 Steven R. Clendenen 451185.000018 9016 43548 7590 12/18/2017 FAEGRE BAKER DANIELS LLP PATENT DOCKETING - INTELLECTUAL PROPERTY 2200 WELLS FARGO CENTER 90 SOUTH SEVENTH STREET MINNEAPOLIS, MN 55402-3901 EXAMINER MEHL, PATRICK M ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 12/18/2017 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): PatentDocketing @ F aegreB D .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN R. CLENDENEN, CLIFTON R. HAIDER, BARRY K. GILBERT, and OLIVER WILLIAM SPEES1 Appeal 2017-010864 Application 14/128,694 Technology Center 3700 Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to a system and method for detecting vascular contamination by surgical anesthetic. Claims 1—4, 9-15, 20, and 33—37 are on appeal as rejected under 35 U.S.C. §§ 101 and 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as “Mayo Foundation for Medical Education and Research.” App. Br. 3. Appeal 2017-010864 Application 14/128,694 STATEMENT OF THE CASE The Specification states: The use of local anesthesia... renders an area insensitive to pain without affecting consciousness, speeding the detection of complications and patient recovery. However, when performing a nerve block, relatively large drug doses can be required to inhibit the nerve conduction to the surgical site. By way of example, injection volumes can be in the range of 20-40 cc. Unfortunately, as little as 1 cc of local anesthesia injected into an artery can cause seizure, and large intravascular local anesthesia injection will block the conduction system of the heart, possibly leading to cardiac arrest and death. . . . There remains, therefore, a continuing need for improved systems and methods for providing accurate and early warning of intravascular local anesthesia. Spec. 1—2. Claims 1 and 10 are the independent claims, are representative, and are reproduced below: 1. A method, comprising: applying light from one or more sources to tissue of a patient, wherein the light has multiple wavelengths and includes pulses of light having an excitation wavelength and a predetermined excitation pulse sequence; detecting the light by a light detector after the light has passed through the tissue of the patient, including detecting light having an emission wavelength that is different than the excitation wavelength; processing the detected light by a processing system, including: correlating pulse sequences of detected light having the emission wavelength with the predetermined excitation pulse sequence to identify the recovery of light having the emission wavelength, wherein the recovery of light having 2 Appeal 2017-010864 Application 14/128,694 the emission wavelength is representative of the presence of fluorescing dye-marked anesthetic in the patient’s bloodstream; and processing the detected light to determine the blood oxygen saturation level of the patient; and displaying concurrently the patient’s blood oxygen saturation level, and information representative of the presence of dye- marked anesthetic in the patient’s bloodstream based on the recovery of the light having the emission wavelength. 10. An instrument for use in connection with a patient receiving fluorescing dye-marked anesthetic, comprising: a probe configured to be positioned on the patient, including: a source of light having multiple wavelengths, including pulses of light having an excitation wavelength and a predetermined excitation pulse sequence; and a detector for detecting light, including light having an emission wavelength that is different than the excitation wavelength; a processing system coupled to the probe, wherein the processing system concurrently: correlates detected pulse sequences of light having the emission wavelength with the predetermined excitation pulse sequence to identify the recovery of light having the emission wavelength, wherein the recovery of light having the emission wavelength is representative of the presence of the fluorescing dye-marked anesthetic in the patient’s bloodstream; and processing the detected light to determine the blood oxygen saturation level of the patient; and a display coupled to the processing system to display the patient oxygenation information and information representative of the 3 Appeal 2017-010864 Application 14/128,694 presence of the dye-marked anesthetic in the patient’s bloodstream. App. Br. 18, 19 (Claims App’x.). The following rejections are on appeal: Claims 1—4, 9—15, 20, and 34—37 stand rejected under 35U.S.C. § 101 as being patent-ineligible. Final Action 3. Claims 1—4, 9—15, 20, and 33-37 stand rejected under 35 U.S.C. § 103(a) over Corlu,2 Chen,3 and Nagpal.4 Id. at 9. FINDINGS OF FACT Except as otherwise indicated herein, we adopt the Examiner’s findings of fact, reasoning on scope and content of the claims and prior art, and conclusions set out in the Final Action and Answer. We identify the following facts to highlight certain evidence. FF1. Corlu is directed to and discloses using “the fluorophore Indocyanine Green (ICG)[,j . . . injected intravenously” to obtain “images of human breast cancer based on fluorescence,” which teaches, generally, the “applying light,” “detecting light,” “processing light”, “and displaying light” claim elements, insofar as they relate to 2 Corlu et al., Three-dimensional in vivo Fluorescence Diffuse Optical Tomography of Breast Cancer in Humans, 15 Optics Express 6696—716 (2007) (“Corlu”). 3 US 5,402,779 (issued Apr. 4, 1995) (“Chen”). 4 Dr. Manish Nagpal, Combined Fluorescein, Indocyanine Angiography and Optical Coherent Tomography Using Spectralis, Rajasthan J. Opthamology (8 pages, numbered as printed from online source) (2011), http://www.rostimes.eom/2011RJO/-RJ020110101.htm, visited May 17, 2016 (“Nagpal”). 4 Appeal 2017-010864 Application 14/128,694 exciting a molecule with light, detecting the light then emitted by that molecule, correlating that detected emitted light as representative of the presence of the fluorescing molecule, and displaying that information. Corlu 6696 (Abstr.); see also Final Action 9—16 and Answer 12—18 (discussing Corlu). FF2. Corlu discloses “deliver[ing] light from four sinusoidally intensity modulated (70 MHz) laser diodes operating at 650, 690, 786 and 830 nm,” where “[a] diode laser at 786 nm is utilized for excitation of ICG and fluorescence,” which results in ICG having a CCD-camera-measured “excitation wavelength [of] 786 nm,” whereby “ICG pharmacokinetics” is derived, which teaches the claim elements relating to “multiple wavelengths” of applied light, “an excitation wavelength,” “detecting light by a light detector after the light has passed through the tissue,” the “emission wavelength that is different than the excitation wavelength,” and “correlating . . . detected light having the emission wavelength ... [so as to be] representative of the presence of the fluorescing dye ... in the patient’s bloodstream.” Corlu 6700-05; see also Final Action 9-16 and Answer 12—18 (discussing Corlu). FF3. Corlu discloses also collecting blood oxygen saturation (St02) data, along with ICG fluorescence data, and displaying each together, simultaneously, which teaches the “processing the detected light to determine the blood oxygen level” and “displaying concurrently” claim elements. Corlu 6703—14 (see Figs. 11, 14, 16); see also Final Action 9-16 and Answer 12—18 (discussing Corlu). 5 Appeal 2017-010864 Application 14/128,694 FF4. Chen discloses: A method and apparatus in which an anesthesia catheter is inserted into the epidural space of the patient. A blood soluble dye mixed with a local anesthetic is injected through the catheter and into the patient. A transducer clip is positioned on the finger of the patient for monitoring the light responsive characteristics of the patient's blood. A transducer signal is fed to a microprocessor for generating a real time display for indicating to the anesthesiologist that the dye, and therefore the local anesthetic, is present in the bloodstream. Chen Abstr.; see also Final Action 9, 11—14, 16—17 and Answer 12, 14—16, 18 (discussing Chen). FF5. Further to the preceding finding of fact, Chen discloses that the dye can be ICG dye, which “has been used since the 1940’s and has been shown to be safe when injected intravascularly. Its presence within the blood stream is detected at a distant site by the use of spectrophotometric equipment.” Chen 4:41—65.; see also Final Action 9, 11—14, 16—17 and Answer 12, 14—16, 18 (discussing Chen). Chen teaches ICG dye is useful in combination with and for non- invasively detecting anesthetic in a patient’s bloodstream, which reasonably identifies another use for the system and method of Corlu, which uses the same dye and roughly similar techniques. According to the Examiner, it would have been reasonable for the skilled artisan to expect to successfully use the system and method of Corlu in place of that of Chen for the purpose of Chen, that is, to detect anesthetic associated with ICG in the bloodstream. See Final Action 11. FF6. Chen discloses measuring light absorbance by ICG and the respective change in emitted light, rather than utilizing the known 6 Appeal 2017-010864 Application 14/128,694 fluorescing property of ICG in detecting the dye in a patient’s bloodstream. Chen 4:66—5:20. FF7. Nagpal is directed to and discloses combined fluorescein angiography (FA), indocyanine green (ICG) angiography, and optical coherent tomography (OCT), most specifically for non-invasively imaging the vasculature of the retina, and discloses that the light absorption and light emission properties of ICG were well known. Nagpal 1; see also Final Action 9, 12—16 and Answer 12, 15—18 (discussing Nagpal). FF8. Nagpal discloses: simultaneous [ly measuring] FA and ICG-A, [where] the laser radiation is deflected by means of a resonant scanner so that the two are done quasi-simultaneously. The infrared laser is guided onto each line scan, and the blue radiation is applied during the return movement of the scanning mirror. Images are digitized upto the rate of 20 frames per second with the time separation between corresponding lines of two angiograms being in the order of 0.1ms. Nagpal 2 (also specifically disclosing “time sequence correlation” and “scan[ning] images at 40 kHz”); see also Final Action 9, 12—16 and Answer 12, 15—18 (discussing Nagpal). This teaches that excitation illumination can be applied at “a predetermined excitation pulse sequence” and that the related detected emitted light can then be correlated as representative of the presence of fluorescing dye in the bloodstream. See Answer 15—16. 7 Appeal 2017-010864 Application 14/128,694 DISCUSSION Only those arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision. Arguments not so presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). Obviousness “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. It is obvious to those skilled in the art to substitute one known equivalent for another, be those equivalents method steps or apparatus components. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) To the extent Appellants argue over the prior art references individually, such arguments are not persuasive. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). 8 Appeal 2017-010864 Application 14/128,694 Under the above-cited precedent in view of the facts highlighted above, we conclude the Examiner has established that the claims would have been obvious over the combination of Corlu, Chen, and Nagpal. See Final Action 9—17. As determined by the Examiner, Chen teaches and suggests that ICG dye is useful, safe, and compatible with anesthetic for non- invasively detecting associated anesthetic in a patient’s bloodstream using light. FF4—FF5. Further, while Chen uses the light-absorbing property of ICG to detect associated anesthetic (FF6), Corlu discloses that ICG’s known fluorescence can be detected in the bloodstream as well (and imaged), and also teaches the remainder of the method and apparatus defined by independent claims 1 and 10. FF1—FF3. Moreover, while Corlu and Chen do not specify using “a predetermined excitation pulse sequence” and the related elements that necessarily flow therefrom, as claimed, Nagpal teaches that, when using ICG fluorescence to image vasculature, a predetermined excitation pulse sequence and related correlation to the light for imaging and displaying is useful, particularly when imaging with multiple fluorescing markers. FF7—FF8. While Appellants separately group the claims in their Appeal Brief in arguing patentability over the Corlu-Chen-Nagpal combination, the arguments presented are substantially similar and we address them together, except where otherwise necessary. In arguing the patentability of claim 1 (and its dependent claims 2-4, 9, 36, and 37) and claim 10 (and its dependent claims 13—15, 20, and 33— 35), Appellants argue Corlu “has absolutely nothing to do with anesthetic monitoring” and “therefore does not teach the concurrent display of 9 Appeal 2017-010864 Application 14/128,694 information relating to the presence of anesthetic in the bloodstream and blood oxygen saturation.” App. Br. 12, 14. While Appellants are correct that Corlu is not directed to monitoring anesthetic, Chen is, and both references utilize the same fluorescing molecule, ICG, to detect its presence in the bloodstream. Because we conclude, for at least this commonality, that it would have been reasonable for the skilled artisan to have combined these references, Appellants’ argument over Corlu is not persuasive. Appellants argue Chen, while teaching using ICG dye as a marker for local anesthetic, “does not teach the use of the fluorescing properties of the ICG dye, as recited in the claims.” App. Br. 12, 14. Again, while Appellants are correct that Chen is not directed to using the (well known) fluorescing property of ICG to detect its presence in a patient’s bloodstream, Corlu does teach doing so and we have concluded that Corlu and Chen are reasonably combined. Therefore, Appellants’ argument over Chen individually is not persuasive. Further, Appellants argue, Since the imaging procedure described by the Corlu article does not involve anesthetic, there would have been no reason [to] incorporate the anesthetic monitoring technology of the Chen patent into the imaging procedure of the Corlu article. Perhaps even more significantly, the very different natures of the technologies of the Corlu and Chen references render them incompatible for combination. App. Br. 12, 15. Appellants urge that Corlu is directed to intentionally injecting dye for detection at a tumor while Chen is directed to monitoring the inadvertent entry of the anesthetic and dye into a patient’s bloodstream, which, Appellants contend, conflict with one another. Id. at 12—13, 15. We 10 Appeal 2017-010864 Application 14/128,694 conclude that it would have been reasonable to use the system components and methodology steps of Corlu for the similar or equivalent system components and methodology steps of Chen to achieve the objective of Chen, which is detecting the presence of ICG and associated anesthetic in a patient’s bloodstream. FF1—FF5. Therefore, Appellants’ arguments are not persuasive. Appellants also argue: the Nagpal article does not disclose the claimed use of pulsed light excitation and the correlation of a detected light sequence with the pulse sequence to identity the presence of dye-marked anesthetic. Instead, the Nagpal article describes the combined injection of both fluorescein and ICG dyes in connection with a simultaneous angiography technique during which fluorescein angiography (FA) images and ICG-An images are acquired simultaneously. The article describes the “time sequence correlation” pointed to in the Office Action as meaning “[bjoth the dyes are injected and, therefore, imaged simultaneously. Therefore the physiological difference in their distribution and circulation through the eye are easily discernible.” The described correlation therefore relates to the relative timing of the two imaging techniques. This disclosure is wholly unrelated to the correlation of predetermined excitation pulse sequences with the pulse sequences of detected light. App. Br. 13, 15 (internal footnotes omitted). The claims do not define any specific “predetermined excitation pulse sequence,” thus, any predetermined sequence of excitation illumination that is correlated with detected emission light (e.g., ICG fluorescing) so as to be representative of the fluorescing dye’s and associated anesthetic’s presence in a patient’s bloodstream falls within the scope of this claim element. Nagpal teaches such a predetermined excitation pulse sequence, as claimed, and it would have been obvious to use 11 Appeal 2017-010864 Application 14/128,694 such when collecting data based on a spectrum of excitation light, resultant marker fluorescence, and simultaneous blood O2 saturation data, as taught byCorlu. FF1-FF3, FF7-FF8. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[Ajppellanf s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”) For these reasons, Appellants’ argument is not persuasive. Appellants separately argue the non-obviousness of each of claim 11 and claim 12 over the cited prior art combination. App. Br. 16. However, the arguments presented essentially restate those presented for the patentability of claim 1, that the subject matter of the Corlu article has absolutely nothing to do with anesthetic monitoring. Unlike the claimed invention, the Corlu article does not teach or suggest either (1) processing detected light to identify the presence of dye-marked anesthetic in a patient's bloodstream, or (2) the display of information representative of the presence of dye-marked anesthetic in the patient's bloodstream. It therefore does not teach the simultaneous display of information relating to the presence of anesthetic in the bloodstream and blood oxygen saturation. Id. at 16—17. Therefore, for the reasons set forth above, we also are unpersuaded by this argument. For the reasons above, we affirm the obviousness rejection. Patent Eligibility “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Mayo Collaborative Servs. v. Prometheus Labs, Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalkv. 12 Appeal 2017-010864 Application 14/128,694 Benson, 409 U.S. 63, 67 (1972)). Claims directed to nothing more than abstract ideas (such as mathematical algorithms), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185 (1981); accord MPEP § 2106 (II) (discussing Diehr). In analyzing patent-eligibility questions under 35 U.S.C. § 101, the Supreme Court instructs us to “first determine whether the claims at issue are directed to a patent-ineligible concept.” Alice Corp. Pty Ltd. v. CLS Banklnt’l, 134 S. Ct. 2347, 2355 (2014). If the initial threshold is met, we then move to a second step and “consider the elements of each claim individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 566 U.S. at 97). Under the above-cited precedent, we conclude the claimed invention is not patent-ineligible. The Examiner determined that claim 1 is directed to the abstract idea(s) of: “correlating pulse sequences of detected light having the emission wavelength with the predetermined excitation pulse sequence to identify the recovery of light having the emission wavelength”, “the recovery of light having the emission wavelength is representative of the presence of fluorescing dye- marked anesthetic in the patient’s bloodstream”, “processing the detected light to determine the blood oxygen saturation level of the patient”. Final Action 3. The Examiner determined that claim 10 is directed to the abstract idea(s) of: “correlates detected pulse sequences of light having the emission wavelength with the predetermined excitation pulse sequence to 13 Appeal 2017-010864 Application 14/128,694 identify the recovery of light having the emission wavelength, wherein the recovery of light having the emission wavelength is representative of the presence of the fluorescing dye-marked anesthetic in the patient’s bloodstream” and “processing the detected light to determine the blood oxygen saturation level of the patient”. Notably, these steps are not required to be performed by a computer processor, per se, and thus also read on mental activity. Id. at 3^4. The Examiner further explained, “[t]he reasons that the limitations are considered an abstract idea are: although not drawn to the same subject matter, these claimed limitations are similar to mathematical concepts or operations for manipulating and/or relating data, organizing information through correlations; calculating parameters; and/or collecting and comparing known data, i.e. ‘an idea of itself.” Id. at 4. Having determined that the claims are directed to an abstract idea, which is patent-ineligible, turning to the second required analysis step under Alice, the Examiner determined that the receiving and displaying steps of claim 1 and the light source, sensor, and display elements of claim 10 were merely routine and conventional and, thus, not additional claim elements that amounted to significantly more than the abstract idea(s) so as to make the claims patent eligible. Id. 4—5. Appellants argue claims 1 and 10, and their respective depending claims, separately. However, the arguments are essentially the same and we address them together. Appellants argue the claimed invention is not directed to an abstract idea, but is directed to “a method for applying, detecting and processing light in a particular manner, and then displaying concurrently the patient’s blood oxygen saturation level and information representative of the presence 14 Appeal 2017-010864 Application 14/128,694 of dye-marked anesthetic.” App. Br. 6—7, 9. Appellants also argue that the “very specific approach claimed,” i.e., “correlating the pulse sequences of the detected light with the predetermined excitation pulse sequence to identify the recovery of light representative of the dye-marked anesthetic,” is an improvement in the technology because it “improve[es] morbidity.” Id. at 7, 9. Appellants further argue that “[t]he Office Action does not identify any particular abstract idea recited by the claims,” but merely concludes the claims are directed to such and points to limitations recited by the claims as describing the same. Id. at 7, 10. Appellants argue that, if the claims were found to be directed to an abstract idea, they recite substantial additional elements that provide patent eligibility, including: the steps of (1) applying pulses of light having a predetermined excitation pulse sequence, and (2) correlating the pulse sequences of the detected light (i.e., not the mere presence of the detected light itself) with the predetermined excitation pulse sequence. It is this correlation that is used to (3) identify the recovery of light that is representative of the presence of dye- marked anesthetic in the patient's bloodstream. Id. at 8, 10. While the Examiner has followed the correct steps of analysis required by the Supreme Court’s holding in Alice, we do not agree with the conclusion. The claims are not directed to merely manipulating data nor are they directed to mere mathematical calculations. The claims are also not directed to the natural phenomena of a correlation between a detectable amount of fluorescing dye and a count of dye molecules. The claims are also not 15 Appeal 2017-010864 Application 14/128,694 directed to the concept that a molecule can be made to fluoresce when excited by light; they are not directed to the concept that a fluorescent molecule can be attached to or provided with an anesthesia molecule. These would arguably be natural phenomena. The claims are directed to taking advantage of these concepts to (1) make anesthesia detectable and (2) noninvasively detect anesthesia in a patient’s blood; which, as explained in the Specification, can prevent seizure and cardiac arrest in the patient. See Diamond v. Diehr, 101 S.Ct. 1048 (1981) (the invention relied on a mathematical formula, the Arrhenius equation, as a part of a greater manufacturing process, but did not claim the equation itself, but rather, claimed an improved rubber curing process); Rapid Litigation Management LTD v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (the claimed process of producing a preparation of hepatocytes, as a whole, was not directed to a natural law itself and was not routine or conventional, it advantageously applied a natural discovery in a way that achieved a new and useful end). While the claims here may rely on natural phenomena and abstract mathematical correlations, as did those in Diehr and CellzDirect, “[a]t some level, ‘all inventions . . . embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.’” Alice, 134 S.Ct. at 2354 (quoting Mayo, 132 S.Ct. at 1293) (emphasis added); see also Amdocs (Israel) Ltd. v. Openet Telecom, Inc., 842 F.3d 1288, 1299 (Fed. Cir. 2016) (indicated the same in finding claims patent-eligible). The claims are not directed to, and would not preempt, measuring fluorescence or using math to correlate a fluorescence measurement to the presence of or an amount of a 16 Appeal 2017-010864 Application 14/128,694 fluorescing molecule. No more than this would likely be an abstract idea, but the claims go further and apply such features to a larger process or system, which cannot be ignored when considering the claims in their entirety. Having concluded that the claims are not directed to an abstract idea (or natural phenomena), we need not proceed to Alice’s step two. See Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017) (the claims relied on, but were “not merely directed to the abstract idea”). We reverse the patent-ineligibility rejection. SUMMARY The rejection of the claims as directed to patent-ineligible subject matter is reversed. The rejection of the claims as obvious over the cited prior art combination is affirmed. TIME PERIOD FOR RESPONSE 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 17 Copy with citationCopy as parenthetical citation