DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Specification The disclosure is objected to because of the following informalities: The reference character “112” has been used to refer to “light delivery catheter” in paragraph 0062, line 8 and “the needle catheter” in paragraph 0062, line 9. Appropriate correction is required. Claim Objections Claims 1 , 7 and 8 are objected to because of the following informalities: Regarding claim 1, line 6, the recitation “skin tissue” has been amended to recite “the skin tissue” in order to refer to “a skin tissue” recited in claim 1, line 1. Claim 7 recites the limitation “the disinfection conditions” in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 7 recites the limitation “the information” in line 7. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 8, line 2, the recitation “angel” appears to be amended to recite “angle”. Claim 8 recites the limitation “the end” in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 8 and 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 8, the recitation “wherein the light is radiated toward …the light delivery catheter” renders the claim indefinite because the claim is unclear if the claimed invention is positively reciting an action of light being radiated towards the end of the injection needle or if the claimed invention is capable to emit the light toward the end of the injection needle at a claimed angle range. For examination purposes, examiner construes that the device is capable to radiate the light toward the end of the injection needle at a claimed angle. Regarding claims 15-16, the recitation of “an end portion of the injection needle” renders the claim indefinite because the claim is unclear if “the injection needle” is positively claimed as a part of the claimed invention. For examination purposes, examiner construes that the device is capable to be used with the injection needle as claimed. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 1 , 3, 4, 6, 8 and 14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Butler (US 2004/0193218 A1) . Regarding claim 1, Butler teaches a light-based disinfection device (figure 1A) configured to achieve disinfection (paragraph 0059, lines 1-5) of a skin tissue by placing light in close proximity to an injection needle for drug injection, the light-based disinfection device (figure 1A) comprising: a light delivery catheter 112 comprising one end portion (end portion of element 112 connected to element 122) connected to a control device 122 and a remaining end portion (remaining portion of element 112) configured to direct light from a light source 104 (paragraph 0058) controlled by the control device toward skin tissue; a needle catheter 106 comprising one end portion (portion of element 106 connected to element 118) connected to a drug container 118 and to accommodate a catheter line (line of element 106) that supplies a drug, and a remaining end portion (remaining portion of element 106 could be connected to an injection needle using appropriate connector) configured to accommodate an injection needle that receives the drug from the catheter line and injects the drug into a patient's body; and a coupler 102a (prior art specification uses the reference character 102 however examiner would refer to element 102a as shown in figure 2A to refer to cannula) configured to couple the light delivery catheter and the needle catheter in parallel to each other in a longitudinal direction (longitudinal direction of element 102) . Regarding claim 3, Butler teaches wherein the light source 104 comprises an optical element (end of element 104 that transmits light) disposed at the remaining end portion of the light delivery catheter 112 to be connected to control lines and power lines (lines connecting ends of element 104 to elements 116 and 122) extending from the control device 122 . Regarding claim 4, Butler teaches wherein the light source 104 comprises an optical fiber 104 that delivers light generated by the control device 122 and has an end portion disposed at the remaining end portion of the light delivery catheter 112. Regarding claim 6, Butler teaches wherein the light source 104 is configured to be controlled by the control device 122 (paragraph 0058) in terms of one or more disinfection conditions from among a light intensity, a light emission time, selection of a continuous or pulsed light delivery method, a light output energy or power range, selection of a light distribution, and a number of times of disinfection operation. Regarding claim 8, Butler teaches wherein the light (see figure 3A where light is radiated at 90 degrees with respect to a distal end of element 106 where a needle could be attached) is radiated toward the end of the injection needle at an angle of 30 to 90 degrees by the remaining end portion of the light delivery catheter. Regarding claim 14, Butler teaches wherein the coupler 102a comprises a tube (element 102a is a tube) configured to wrap bodies of the light delivery catheter and the needle catheter to place the bodies of the light delivery catheter and the needle catheter therein. Claims 1 , 2, 9-12, 15, 16, 18 and 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Pesach et al. (US 2010/0152644 A1) . Regarding claim 1, Pesach teaches a light-based disinfection device (figures 18 , 19 and 31 ) configured to achieve disinfection (using appropriate light waves, disinfection could be achieved) of a skin tissue by placing light in close proximity to an injection needle for drug injection, the light-based disinfection device comprising: a light delivery catheter (see “LC” in figure 2, paragraph 0196, lines 9-16 , hollow portion in element 3139 that allows passage of the light ) comprising one end portion (portion connected to processing unit, paragraph 0149, lines 7-11) connected to a control device (paragraph 0149, lines 7-11) and a remaining end portion (remaining portion of “LC” in figure 2 below) configured to direct light from a light source 301, 803, 804 , 3132 controlled by the control device toward skin tissue; a needle catheter 303, 802 (examiner construes “needle catheter” as being a portion that receives/transmits fluid/drug something similar to “C” shown in figure 2 below , portion of element 3139 through which element 3138 passes ) comprising one end portion (portion of element 303, 802 connected to the drug source) connected to a drug container 3130 (paragraph 0195, lines 7-9, source that contains drug) and to accommodate a catheter line (line inside element 303, 802 , 3139 that transfers drug) that supplies a drug, and a remaining end portion (remaining portion of element 303, 802 that comes in contact with the patient is capable to accommodate the injection needle using appropriate connector) configured to accommodate an injection needle that receives the drug from the catheter line and injects the drug into a patient's body; and a coupler 300, 302, 800 (component that keeps two lumens of element 3139 connected to one another) configured to couple the light delivery catheter and the needle catheter in parallel (at least a portion of elements 301, 804, 803 and 303, 802 are parallel, alternatively, “LC” in figure 2 below is parallel) to each other in a longitudinal direction. Regarding claim 2, Pesach teaches wherein the light-based disinfection device is configured to insert the injection needle of the needle catheter into a chemoport inserted into the patient’s body (injection needle connected to the end of elements 303, 802 using appropriate connector is capable to be inserted into a chemoport inserted into the patient’s body. Regarding claim 9, Pesach teaches wherein the light delivery catheter further comprises a light diffusion prevention film 3137, 3135 (paragraph 0197, lines 1-5, “optical absorption coating”) at the remaining end portion (see figure 31) to block light reflected or scattered rearward when the light from the light source is radiated to the skin tissue. Regarding claim 10, Pesach teaches wherein the light diffusion prevention film 3137, 3135 (paragraph 0197, lines 1-5, “optical absorption coating”) is configured to be rotatable or bendable (by rotating entire device, elements 3137, 3135 or “optical absorption coating” can be rotated). Regarding claim 11, Pesach teaches wherein the light diffusion prevention film 3137, 3135 comprises a coating film 3137, 3135 configured to reflect or scatter light (see figure 31). Regarding claim 12, Pesach teaches wherein the light diffusion prevention film (paragraph 0197, lines 1-5, “optical absorption coating”) comprises a coating film (paragraph 0197, lines 1-5) configured to absorb light. Regarding claim 15, Pesach teaches wherein when an end portion of the injection needle at the remaining end portion of the needle catheter is bent and directed in a different direction with respect to the longitudinal direction (if the injection needle with bent is attached to the needle catheter of Pesach, the remaining portion of the light delivery catheter will be extending in an extension direction without being bent at least to some portion since attachment of the injection needle to the needle catheter does not need modifying the placement of the remaining end portion of the light delivery catheter) , the remaining end portion of the light delivery catheter extends in an extension direction without being bent. Regarding claim 16, Pesach teaches wherein, when an end portion of the injection needle at the remaining end portion of the needle catheter is bent and directed in a different direction with respect to the longitudinal direction (if the injection needle with bent is attached to the needle catheter of Pesach, the remaining end portion of the light delivery catheter will be staying bent with respect to the end portion of the injection needle and will still continue to direct the light toward the skin tissue since attachment of the injection needle to the needle catheter does not need modifying the placement of the remaining end portion of the light delivery catheter) , the remaining end portion of the light delivery catheter is bent in the other direction to direct the light toward the skin tissue. Regarding claim 18, Pesach teaches wherein the remaining end portion of the light delivery catheter (see “LC” in figure 2 above) comprises a light radiation portion (portion comprising element “LC” in figure 2 above) having a hole (a hole is construed to be formed as an opening in the region where element “C” in figure 2 above is present) for inserting the injection needle (injection needle with appropriate coupler could be inserted into “C” in figure 2 above) , and wherein a plurality of light sources 803, 804 controlled by the control device are arranged around the hole of the light radiation portion (elements 803 and 804 are present on either sides of element 801) . Regarding claim 19, Pesach teaches further comprising: a light radiation regulation portion 3137, 3135 configured to diffuse or scatter the light from the remaining end portion of the light delivery catheter to regulate the light to have a predetermined light radiation range, light radiation intensity, or light distribution on the skin tissue (see figure 31) . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Butler (US 2004/0193218 A1) in view of Babaev (US 2003/0153961 A1) and further in view of Rhodes et al. (US 2013/0267888 A1) . Regarding claim 5, Butler discloses the claimed invention substantially as claimed, as set forth above in claim 1. Butler further discloses wherein the light source 104 is configured to emit laser beams, near-ultraviolet rays, visible rays or near-infrared rays as continuous or pulsed light with a wavelength ranging from 400 nm to 3000 nm (paragraph 0044) but is silent regarding an energy density of 0.01 to 10 J/cm 2 . Rhodes teaches a method and apparatus to inactivate infectious agents wherein an energy density of 0.1 to 100 J/cm 2 (paragraph 0016) for the purpose of performing sterilization process (paragraph 0016). However, Rhodes is silent regarding an energy density of 0.01 to 10J/cm 2 . It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the energy density of Rhodes from between 0.1 to 100 to between 0.01 and 100 J/cm 2 since it has been held that “[ i ]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [ 0059 ] indicating the energy density “may” be within the claimed range). Butler is further silent regarding power density of 0.01 to 10W/cm 2 . However, Babaev a device for wound treatment wherein power density of 0.01 to 10W/cm 2 (paragraph 0046, lines 15-20) for the purpose of disinfecting the wound surface and improve healing outcome (paragraph 0015). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the power density of Butler to incorporate power density of 0.01 to 10W/cm 2 as taught by Babaev for the purpose of disinfecting the wound surface and improve healing outcome (paragraph 0015). Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Butler (US 2004/0193218 A1) in view of Kopperschmidt et al. (US 2019/0374668 A1) . Regarding claim 7, Butler discloses the claimed invention substantially as claimed, as set forth above in claim 1. Butler further discloses the control device can be programmed (paragraph 0035) and therefore, one of ordinary skill in the art can infer that Butler is inherently disclosing the presence a user interface. However, Butler does not explicitly recite further comprising: a user terminal connected to the control device in a wired or wireless manner, wherein the user terminal is configured to control an operation of the light source by transmitting the disinfection conditions or a schedule comprising one or more lists of the disinfection conditions stored in advance to the control device, to store information on the controlled disinfection conditions or schedule which have been transmitted to the control device and under which the operation of the light source has been controlled, and to provide the information in response to a user's inquiry request. Kopperschmidt teaches a design of an automatic disinfecting machine further comprising: a user terminal (paragraph 0107, “user interface device”, paragraph 0104, lines 1-6) connected to the control device in a wired or wireless manner, wherein the user terminal (paragraph 0022, lines 14-18) is configured to control an operation of the light source by transmitting the disinfection conditions or a schedule comprising one or more lists of the disinfection conditions stored in advance to the control device, to store information on the controlled disinfection conditions or schedule which have been transmitted to the control device and under which the operation of the light source has been controlled, and to provide the information (paragraph 0107, “output”) in response to a user's inquiry request for the purpose of using the user input commands to control the operation of the light source (paragraph 0107, paragraph 0022, lines 14-18) . Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of Butler to incorporate further comprising: a user terminal connected to the control device in a wired or wireless manner, wherein the user terminal is configured to control an operation of the light source by transmitting the disinfection conditions or a schedule comprising one or more lists of the disinfection conditions stored in advance to the control device, to store information on the controlled disinfection conditions or schedule which have been transmitted to the control device and under which the operation of the light source has been controlled, and to provide the information in response to a user's inquiry request as taught by Kopperschmidt for the purpose of using the user input commands to control the operation of the light source (paragraph 0107, paragraph 0022, lines 14-18) . Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 2010/0152644 A1) . Regarding claim 13, Pesach discloses the claimed invention substantially as claimed, as set forth above in claim 1. Pesach is silent regarding wherein the coupler comprises a catheter connector configured to be placed and rotated around the light delivery catheter or the needle catheter in one embodiment. However, Pesach teaches in a different embodiment wherein the coupler 756 comprises a catheter connector 756 (element 756 could be rotated around element 751 by rotating element 753) configured to be placed and rotated around the light delivery catheter or the needle catheter for the purpose of using an alternative mechanism of separating the device into two parts, disposable and reusable, thereby storing different components of the device into two separate parts (paragraph 0178) . Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the coupler of one embodiment of Pesach to incorporate wherein the coupler comprises a catheter connector configured to be placed and rotated around the light delivery catheter or the needle catheter as taught by different embodiment of Pesach for the purpose of using an alternative mechanism of separating the device into two parts, disposable and reusable, thereby storing different components of the device into two separate parts (paragraph 0178) . Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pesach et al. (US 2010/0152644 A1) in view of Thawer et al. (US 2020/0054842 A1) . Regarding claim 17, Pesach discloses the claimed invention substantially as claimed, as set forth above in claim 1. Pesach further discloses wherein, the injection needle at the remaining end portion of the needle catheter extends in an extension direction without being bent (injection needle without bent could be attached to the remaining end portion of the needle catheter) but is silent regarding the light source disposed at the remaining end portion of the light delivery catheter is configured to be rotated or bendable such that a light radiation direction can be changed. However, Thawer teaches a design of a tip determiner for an injection device comprising the light source 114, 116 disposed at the remaining end portion of the light delivery catheter 102 is configured to be rotated (paragraph 0071, lines 1-9) or bendable such that a light radiation direction can be changed for the purpose of changing the direction of the light radiation thereby radiating light on the desired site of interest to perform necessary medical procedure (paragraph 0071, lines 1-9). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of Pesach to incorporate the light source disposed at the remaining end portion of the light delivery catheter is configured to be rotated or bendable such that a light radiation direction can be changed as taught by Thawer for the purpose of changing the direction of the light radiation thereby radiating light on the desired site of interest to perform necessary medical procedure (paragraph 0071, lines 1-9). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NILAY J SHAH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9689 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 8:00 AM-4:30 PM EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT CHELSEA STINSON can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-1744 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NILAY J SHAH/ Primary Examiner, Art Unit 3783