Unrrep States PATENT AND TRADEMARK OFFICE Tass0| Toawa011 Tonathan I. Koha POD077O.USULGTOIRS wm Medtronic, Ine. (CRDM) . pace 710 MEDTRONIC PARKWAY NE THO CHOGIUAN MS: L.C340 Legal Patents MR POL Waeeco ae ARTUNIT PAPER NUMBER ouvir 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 communi following e-mail address(es): ssdocketingus@medtronie.com ‘medtronie_erdm_docketing@cardinal-ip.com ion was sent electronically on above-indicated "Notification Date” to the PTOL-9OA (Rev.0407)‘Application No. Applicant(s) 137289, 020, KUHN, JONATHAN Office Action Summary Examiner ‘ak Unit] AIR re rT Fy CHU CHUAN (Ju) LIU 3777 oon = The MAILING DATE of this communication appears on the cover sheet with the correspondence address = Period for Reply A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF THIS COMMUNICATION. serra tay be aia un bro t 5G 488). noo wa Hos ay apy ys UNO pee rep spaced above he mime scary per wi apy andl xe SK 2) MONTHS rm he malo dal hs communcaton Fale to epy win he sto oxo poof oy wl sto ease fu appicaon to become ABANDONED 05 US'S § 198 Keygen Ost Pao ete sr mang ae cori ovr ho ay ny Status 1)B2_ Responsive to communication(s) filed on 12/05/2013. DIA deciaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on 2a)Q3) This action is FINAL. 2000 This action is non-final 3). An election was made by the applicant in response to a restriction requirement set forth during the interview on ___ the restriction requirement and election nave been incorporated into this action. 4)C1 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is closed in accordance with the practice under Ex parte Quayle, 1985 C.D. 11, 453 0.G. 213, Disposition of Claims* 5) Claim(s) 123is/are pending in the application. 5a) Of the above claim(s)___is/are withdrawn from consideration. 6) Claim(s)___ is/are allowed. 7) Claim(s) 1-23islare rejected 8) Claims) islare objected to 900 Claims) are subject to restriction and/or election requirement. * if any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a Participating intellectual property ofice forthe corresponding application. For more information, please see hat it events/oohvindax iso or send an inquiry to PPHfeedbackouspto. Application Papers 10)L1 The specification is objected to by the Examiner 11)E] The drawing(s) filed on ___ is/are: )[] accepted or b)L] objected to by the Examiner. Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a. Replacement drawing sheet(s) including the correction is required if the drawing(s) i objected to. See 27 CFR 1.121(¢). Priority under 35 U.S.C. § 119 12)L] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). Certified copies: a)CIAll b)L) Some™ cL None of the 1.01 Certified copies of the priority documents have been received. 20) Certified copies of the priority documents have been received in Application No. 3.0) Copies of the certitied copies ofthe priority documents have been received in this National Stage application from the International Bureau (PCT Rule 17.2(a)) “ S00 the attached detailed Office action fra list ofthe carted copies not received. ‘Atachments) 1) Ba wotce ot Retrences cred (PT0-852) 2) renew summary 70-413) Paper No(s) a, 2) itomaton dscosure Sateen) (PTO'SBCEa andor PTOSBO8) Paper No(s)Mail Date 2 Dotter:Application/Control Number: 13/283,930 Page 2 Art Unit: 3777 DETAILED ACTION 1. The present application is being examined under the pre-AIA first to invent provisions 2. Applicant's amendments/ remarks filed on 12/05/2013 have been fully considered. 3. Claims 1-23 are pending for examination Claim Rejections - 35 USC § 103 4, The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is net identically disclosed or described as sat forth in section 102 of ths tt, i the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been ‘obvious at the time the invention was made to a person having ordinary skil in the art to which said subject matter pertains, Patentability shall nat be negatived by the manner in which the invention was made, 5. Claims 1-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Anderson et al. (USPN 5,879,294 — applicant cited) in view of Kiani-Azarbayjany et al. (USPN 5,638,816 — cited in previous action) and further in view of Lipson (USPGPUB 2005/0124870). In regard to claims 1 and 11, Anderson discloses a method and a system for using a medical device comprising an optical sensor to measure calibrated oxygen saturation in a body tissue (abstract, Figs. 1-4 and 15), comprising: establishing a standard spectral response of blood for a plurality of oxygen saturations (Figs 1-3); establishing a standard spectral response of a reference material (Fig. 7 and Col 9 lines 1-48; element 1504, Fig. 1 ind blood sample, Fig. 19 and associated descriptions); determining the spectral power output of the optical sensor (elementApplication/Control Number: 13/283,930 Page 3 Art Unit: 3777 1512, Fig. 15; Col 12 line 50 — Col 13 line 14); obtaining the optical sensor output signal response to the reference material (Fig. 7 and Col 9 lines 1-48); determining a calibration curve for the optical sensor (Fig. 4 and associated descriptions) using the standard spectral response of blood (Figs. 1-3); and storing the calibration curve (abstract, memory 1552, Fig. 15). Anderson does not specifically disclose determining a calibration curve for the optical sensor using the measured spectral power output and determining an optical gain using the standard spectral response of the reference material and the measured spectral power output of the optical sensor; and storing the optical gain. Kiani-Azarbayjany teaches the use of a plurality of LEDs to perform NIR spectroscopic measurements and a method comprises determining the output of an optical power sensor (element 301A, Fig. 28) of each LED to normalize the detected optical signal with a ratio a which represents the optical characteristic of each LED (Fig. 2B and Col 17 lines 17-29). Anderson discloses using an optical power sensor (element 1512, Fig. 15) to control the output of the light emitting source (broadband or four distinct wavelengths, Col 8 lines 16-19) to be maintained in a constant level (element 1512, Fig. 15). The normalization method and the light source configurations taught by Kiani-Azarbayjany is an alternative equivalent method to obtain accurate optical outputs of the spectroscopic system. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention was made to substitute the feedback control method and the light source (Anderson) with the feedback control method and the light sources configurations (Kiani-Azarbayjany) to yield predictable results. Anderson as modified by Kiani-Azarbayjany does not specifically disclose determining an optical gainApplication/Control Number: 13/283,930 Page 4 Art Unit: 3777 for converting a voltage signal, generated by the optical sensor to a remittance measurement, the optical gain being determined by: using the standard spectral response of the reference material and the measured spectral power output of the optical sensor to generate a remittance curve for the reference material that is expected to be measured by the optical sensor, and dividing the expected remittance curve by an actual voltage signal produced by the optical sensor responsive to the optical sensor detecting remitted light from the reference material. Lipson teaches determining an optical gain (scaling factor, [0067}) for converting a voltage signal (actual reading [0067]), generated by an optical sensor (Fig. 6) to an optical measurement signal ({0067}), the optical gain being determined by: using the standard spectral response of the reference material and the measured spectral power output of the optical sensor to generate a scaling factor ([0067)) to be used to in a sample measurement (Fig. 6 and [0067}). Anderson as modified by Kiani-Azarbayjany discloses the use of a reference material (element 606, Fig. 7-9; Col 9 line 1 — Col 10 line 35 of Anderson) and the detector calibration coefficients can be adjusted (Fig. 7-9 and Col 9 line 1 - Col 10 line 35 of Anderson). It is known in the art that the associated electronic elements andi or signal transmission path(s) of an optical detecting system have certain characteristics that may affect the detected optical signal(s) as evidenced by Al-Ali et al. (USPGPUB 2011/0196211). Thus, the actual output of the sensor (Figs. 7-9 of Anderson) may not be identical to the desired output corresponding to the property of the reference material. Lipson teaches the spectrum characteristic of the reference material can be preserved by scaling the actual readings with a scaling factor ([0067)). The scalingApplication/Control Number: 13/283,930 Page 5 Art Unit: 3777 factor can be determined by dividing the desired output corresponding to the property of the reference material with the actual output of the sensor. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention was made to modify the method and the system (Anderson as modified by Kiani-Azarbayjany) to incorporate the concept of the scaling factor determining method (Lipson) in order to better calibrate the optical sensor and obtain more accurate measurements. In regard to claims 2 and 12, Anderson as modified by Kiani-Azarbayjany and Lipson discloses the optical sensor comprises a plurality of light sources emitting light at spaced apart wavelengths (four distinct wavelengths, Col 8 lines 16-19 of Anderson; Fig. 2 of Kiani-Azarbayjany; Figs. 1-4 and 22-24 of Anderson), and wherein establishing the spectral response of blood comprises establishing the spectral response over a range of light wavelengths encompassing the spaced apart wavelengths (four distinct wavelengths, Col 8 lines 16-19 of Anderson; Figs. 1-4 of Anderson). In regard to claims 3 and 13, Anderson as modified by Kiani-Azarbayjany and Lipson discloses all the claimed limitation except measuring the optical sensor output signal response to the reference material at a plurality of temperatures and determining an optical gain for each of the plurality of temperatures. Anderson as modified by Kiani- Azarbayjany discloses the temperature of the blood sample is heated at 37°C + 0.5°C in the blood flow system (Fig. 19 and associated descriptions of Anderson). It is known that the temperature fluctuations would affect the optical characteristic of the blood sample. Therefore, It would have been obvious to one with ordinary skill in the art at the time of the invention was made to modify the method and the system to measure theApplication/Control Number: 13/283,930 Page 6 Art Unit: 3777 optical sensor output signal response to the reference material at a plurality of temperatures to obtain complete temperature-depended optical information in order to obtain more precise measurements. In regard to claims 4 and 14, Anderson as modified by Kiani-Azarbayjany and Lipson discloses all the claimed limitation except determining a temperature compensated optical gain curve for each of a plurality of spaced apart wavelengths emitted by the optical sensor, and storing the temperature-compensated optical gain curve for each of the wavelengths. Since the temperature-depended optical characteristics of the sample blood can be oblained, it would have been obvious to one with ordinary skill in the art at the time of the invention was made to modify the method and system to determine the temperature compensated optical gain curve for each desired wavelength in order to obtain more accurate optical measurements. In regard to claims 5 and 15, Anderson as modified by Kiani-Azarbayjany and Lipson discloses all the claimed limitations except computing a weighted average remittance at each of a plurality of wavelengths emitted by the optical sensor for each of the plurality of oxygen saturations using the standard spectral response of blood and the measured spectral power output. Anderson as modified by Kiani-Azarbayjany and Lipson discloses generating a calibration curve (Fig. 4 of Anderson) based on the optical measurements and calibrated optical characteristics of a plurality of wavelengths. However, the curve comprises discrete data points along all oxygen saturation ranges. In order to obtain information at specific oxygen saturation value, data interpolation/ weighted average method could be applied. Therefore, it would haveApplication/Control Number: 13/283,930 Page 7 Art Unit: 3777 been obvious to one with ordinary skill in the art at the time of the invention was made to modify the method and system to incorporate data interpolation’ weighted average method to the optical and calibration characteristics of the system in order to generate more complete calibration curve(s). In regard to claims 6 and 16, Anderson as modified by Kiani-Azarbayjany and Lipson discloses computing the calibration curve comprises converting the weighted average remittances for each of the plurality of oxygen saturations to an attenuation spectrum (absorbance, Figs. 1-4 and 20-24 of Anderson), In regard to claims 7 and 17, Anderson as modified by Kiani-Azarbayjany and Lipson discloses determining a scaled second derivative of the attenuation spectra for each of the plurality of oxygen saturations (Figs. 1-4 and 20-24 of Anderson) In regard to claims 8 and 18, Anderson as modified by Kiani-Azarbayjany and Lipson discloses determining calibration coefficients for a curve defining the plurality of oxygen saturations as a function of the scaled second derivative (Figs. 1-4 and 20-24 of Anderson). In regard to claims 9 and 19, Anderson as modified by Kiani-Azarbayjany and Lipson discloses computing a calibration coefficient for computing a total hemoglobin concentration index as a function of a second derivative of the attenuation spectra and the scaled second derivative (Figs. 1-4 and 20-24 of Anderson). In regard to claims 10 and 20, Anderson as modified by Kiani-Azarbayjany and Lipson discloses computing the oxygen saturation in a tissue (Figs. 1-4, of Anderson) by measuring a voltage signal of the optical sensor (element 320, Fig. 2B of Kiani-Application/Control Number: 13/283,930 Page 8 Art Unit: 3777 Azarbayjany), applying the stored optical gain to convert the voltage signal to a remittance signal (storing the optical gain, referring to claims 1 and 10 above; output of element 332, Fig. 2B of Kiani-Azarbayjany can be normalized by the stored gain of each LED), converting the remittance signal to an attenuation signal (absorbance data, (Figs. 1-4 and 20-24 of Anderson), computing a scaled second derivative of the attenuation signal (Figs. 1-4 and 20-24 of Anderson), and computing an absolute oxygen saturation of the tissue using the scaled second derivative and the stored calibration curve (Figs. 1-4 and 20-24 of Anderson). In regard to claim 21, Anderson as modified by Kiani-Azarbayjany and Lipson discloses all the claimed limitations except computing a dot product of the standard spectral response of the reference material measured by a spectrometer and the spectral power output of each wavelength emitted by the optical sensor. However, the standard spectral response of the reference material is known (element 606, Fig. 7-9 and associated descriptions of Anderson) and the normalized emitting power of each LED is obtained (referring to claim 1 above; Fig. 23 of Anderson). It would have been obvious to one with ordinary skill in the art at the time of the invention was made to modify the method to compute a dot product of the standard spectral response of the reference material measured by a spectrometer and the spectral power output of each wavelength emitted by the optical sensor in order to obtain the desired/ expected spectral output of sensor associated with the spectral properties of the reference materialApplication/Control Number: 13/283,930 Page 9 Art Unit: 3777 In regard to claims 22-23, Anderson as modified by Kiani-Azarbayjany and Lipson discloses all the claimed limitations except the limitations recited in claims 22-23. However, Anderson as modified by Kiani-Azarbayjany and Lipson discloses a general method for obtaining a calibration curve and an optical gain for an optical sensor. Similar steps can be applied to the same and/ or different types of optical sensors being utilized by monitoring systems (e.g. invasive or noninvasive; in vivo or in vitro) in order to generate device-specitic calibration parameters. The monitoring systems should be programed to perform associated calibrating functions by using the device-specific calibration parameters. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention was made to modify the method to be applied to same and/ or different types of optical sensors in order to better calibrate the optical sensors and obtain more accurate optical measurements. Response to Arguments 6. Applicant's arguments, see page 1 of Remarks, filed on 12/05/2013, with respect to claims 1, 6, and 16 have been fully considered and are persuasive. The objection of claims 1, 6, and 16 has been withdrawn. 7. Applicant’s amendment and argument with respect to claims 1-20 and new claims 21-23 filed on 12/05/2013 have been fully considered but they are deemed to be ‘moot in views of the new grounds of rejectionApplication/Control Number: 13/283,930 Page 10 Art Unit: 3777 Conclusion 8 Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a) A shortened statutory period for reply to this final action is set to expire THREE. MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. Inno event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action, Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN (JJ) LIU whose telephone number is (871)270-5507. The examiner can normally be reached on M-TH 7:00am~3:30pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen can be reached on (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.Application/Control Number: 13/283,930 Page 11 Art Unit: 3777 Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. (TSE CHEN/ Supervisory Patent Examiner, Art Unit 3777 CHU CHUAN (JJ) LIU/ Examiner, Art Unit 3777