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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/15/26 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 6/22/26, with respect to the rejection(s) of claim(s) 1-6, 8-19, 21 and 23-26 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Friedman et al. (U.S. Pub. 2005/0106710 hereinafter “Friedman”).
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(s) 1-4, 8-11, 13 and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazales et al. (U.S. Pub. 2017/0258550 hereinafter “Vazales”) in view of Gertner et al. (U.S. Pub. 2006/0167531 hereinafter “Gertner”) and Friedman et al. (U.S. Pub. 2005/0106710 hereinafter “Friedman”).
Regarding claims 1, 8, 24-25, Vazales discloses a system for performing intra-corporeal ultraviolet therapy, the system comprising: an endotracheal tube (ETT) (e.g. 101); and a light catheter (e.g. ¶33) comprising: a light delivery portion (e.g. 120), the light delivery portion comprising a set of LEDs (e.g. ¶¶111, 424) positioned to emit light circumferentially outward (e.g. see Fig. 2c); and an ETT connector configured to connect to the ETT (e.g. ¶¶ 62, 64, 123, 26, 161) with a flap valve (e.g. ¶¶171, 186). Vazales teaches the claimed limitations but fails to disclose that the light delivery portion is disclosed at the proximal end and further includes a cooling tube disposed inside the light catheter. However, Gertner teaches that it is known in the art to use leds positioned at the proximal end of the catheter combined with a cooling tube as set forth in Figure 2, element 150; Paragraphs 156, 171, 173 to provide a known means for providing directed light along with cooling channels that prevent the device from damaging tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Vazales, with proximal LEDs and cooling tubes by Gertner, since such a modification would provide the predictable results of providing directed light along with cooling channels that prevent the device from damaging tissue. Vazales in view of Gertner teach the claimed invention including using a cooling fluid, but fail to explicitly claim a cooling channel being centered with and in direct contact with the LEDs. Friedman teaches that it is known to use centrally located cooling channels that are in direct contact with the LEDs as set forth in Figure 2, element 114; Figure 4, element 164 and Paragraphs 12, 54-56, 64-65 to provide enhanced cooling to prevent damage to the LED and/or injury to the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Vazales in view of Gertner, with the centrally located cooling channel as taught by Friedman, since such a modification would provide the predictable results of providing enhanced cooling to prevent damage to the LED and/or injury to the patient.
Regarding claim 2, meeting the limitations of claim 1 above, Gertner further discloses wherein a portion of each LED in the set of LEDs is in direct contact with the cooling tube (e.g. ¶156, 171, 173).
Regarding claim 3, meeting the limitations of claim 1 above, Gertner further discloses wherein within the cooling tube, a coolant gas flows in a first direction towards the at least one opening and exits via the at least one opening, and flows backwards within the light catheter in a second direction opposite to the first direction (e.g. ¶¶135, 156, 171, 173).
Regarding claim 4, meeting the limitations of claim 1 above, Gertner further discloses a heat sink coupled to each LED in the set of LEDs (e.g. ¶179).
Regarding claims 9-11, meeting the limitations of claims 1 and 8 above, Vazales teaches that a compressor system comprising: one or more processors (e.g. control unit; ¶114); an air compressor (e.g. ¶214); and a dual connector (e.g. ¶214; See Figs. 3A-3B), a light catheter (e.g. 103) and a control system (e.g. control unit; ¶114) that controls the duration and intensity of the LEDS are known in the art to be connected to endotracheal tubes.
Regarding claim 13, meeting the limitations of claim 1 above, Gertner further discloses wherein the intensity comprises at least 1,100 microwatt/cm2, 1,500 microwatt/cm2, 2,000 microwatt/cm2, 2,100 microwatt/cm2, 2,200 microwatt/cm2, 2,300 microwatt/cm2, 2,400 microwatt/cm2, 2,500 microwatt/cm2, 2,600 4901-5572-6448 2 microwatt/cm2, 2,700 microwatt/cm2, 2,800 microwatt/cm2, 2,900 microwatt/cm2, 3,000 microwatt/cm2, or 2 milliwatt/cm2 (e.g. ¶¶3, 212).
Regarding claim 26, meeting the limitations of claim 1 above, Gertner further discloses wherein: the light catheter is included in a UV light catheter assembly comprising a protective sleeve (e.g. ¶¶156, 171, 173); the light catheter is configured to be inserted into and deployed within the ETT (e.g. ¶¶156, 171, 173); the light catheter is housed in the protective sleeve when not inserted into the ETT (e.g. ¶¶156, 171, 173); the ETT connector is included in a proximal end of the UV light catheter assembly (e.g. see Figs. 1-3B, Vazales); the ETT connector houses a proximal tip of the light catheter (e.g. see Figs. 1-3B, Vazales); and the ETT connector is configured to directly couple the UV light catheter assembly to the ETT (e.g. see Fig. 3B; Vazales).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazales in view of Gertner and Friedman as applied to claims 1-3 above, and further in view of Bak (U.S. Pub. 2012/0321509 A1).
Regarding claims 5-6, Vazales in view of Gertner and Friedman discloses the claimed invention including the using UV light but fails to explicitly state the system utilizes a peak within the wavelength range of 340-349nm. However, Bak teaches that it is known to UV light with a peak wavelength between 340-349nm as set forth in Paragraphs 21-22 and 52 to provide a known wavelength that disinfects and sterilizes a breathing tube. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Vazales in view of Gertner and Friedman, with the UV range as taught by Bak, since such a modification would provide the predictable results of using a known wavelength range that achieves a disinfecting and sterilizing effect.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazales in view of Gertner and Friedman as applied to claims 1-3 above, and further in view of Anderson et al. (U.S. Pub. 2020/0121943 hereinafter “Anderson”).
Regarding claim 12, Vazales in view of Gertner and Friedman discloses the claimed invention including the light illumination but is silent as to the duration of the illumination. However, Anderson teaches a similar UV therapy and states that the system provides stimulation for at least 20 minutes as set forth in Paragraph 100 and Abstract to provide substantial and reliably treatment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Vazales in view of Gertner and Friedman, with the duration as taught by Anderson, since such a modification would provide the predictable results of providing a duration over 20 minutes to provide substantial and reliable treatment.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazales in view of Gertner and Friedman as applied to claims 8-13 above, and further in view of Dahm (U.S. Pub. 2010/0220472).
Regarding claim 14, Vazales in view of Gertner and Friedman teach a method of deploying the light catheter in the system for performing intra-corporeal ultraviolet therapy of claim 11, the method comprising: connecting the ETT connector (e.g. 13; Vazeles) to the ETT (e.g. 14; Vazales); deploying the light catheter into the ETT by advancing the light catheter through the flap valve (e.g. ¶30; Vazales); providing instructions to the controller to energize the set of LEDs (e.g. 128; Friedman), but fails to explicitly state that the system controls the air compressor to pump air through the air passageway into the cooling tube and out of the at least one opening. However, Dahm discloses using the controller to regulate the light and the air flow to control the temperature during operation as set forth in Figure 5 and Paragraphs 87-89 to provide a means for operating the LEDs without overheating and damaging tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Vazales in view of Gertner and Friedman, with the fan and light control as taught by Dahm, since such a modification would provide the predictable results of controlling the air and light for providing optimum treatment.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazales in view of Gertner and Friedman as applied to claim 14 above, and further in view of Azamian et al. (U.S. Pub. 2016/0128767 hereinafter “Azamian”)
Regarding claims 15-16, Vazales in view of Gertner and Friedman teach a method of deploying the light catheter in the system for performing intra-corporeal ultraviolet therapy with a controller that automatically regulates the light and air to minimize temperature damage, but fails to explicitly state that the system utilizes a thermistor as a sensor as an input. However, Azamian discloses using thermistor during operation as set forth in Figure 5 and Paragraphs 87-89 to provide measurement of tissue temperatures and energy delivery during the treatment for feedback. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Vazales in view of Gertner and Friedman, with the thermistor as taught by Azamian, since such a modification would provide the predictable results of controlling the air and light for providing optimum treatment without overheating.
Claim(s) 17-19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hellstrom et al. (U.S. Pub. 2014/0235942 hereinafter “Hellstrom”) in view of Gertner et al. (U.S. Pub. 2006/0167531 hereinafter “Gertner”) and Friedman et al. (U.S. Pub. 2005/0106710 hereinafter “Friedman”).
Regarding claim 17, Hellstrom teaches a method of treating a patient with a respiratory infection (e.g. ¶51), the method comprising: intubating the patient with an ETT (Figs. 1-2; claims 1 and 20; ¶31); connecting a light catheter to the ETT (e.g. ¶51), wherein the light catheter comprises a set of LEDs and a cooling channel (e.g. ¶¶19, 85); radiating UV-A light outwardly from the light catheter along a substantial length of the light catheter from the set of LEDs to treat an infection in the patient while ventilating the patient (e.g. ¶51 “Wavelengths may be in the range...350-600 nm for anti-microbial action’; In 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); MPEP 2144.05. The prior art and the instant claim overlaps at 350 nm) from a UV light source positioned in the delivery tube to emit UV wavelengths outward from the delivery tube (Fig. 2-5; [0051]) for a threshold duration and a threshold intensity (Fig. 15; [0051]; [0085). Hellstrom discloses the claimed invention above including the light catheter (e.g 10 of Hellstrom) but fails to explicitly state the exact construction of the light catheter. However, Gertner teaches that it is known in the art to use leds positioned at the proximal end of the catheter combined with a cooling tube as set forth in Figure 2, element 150; Paragraphs 156, 171, 173 to provide a known means for providing directed light along with cooling channels that prevent the device from damaging tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Hellstrom, with proximal LEDs and cooling tubes by Gertner, since such a modification would provide the predictable results of providing directed light along with cooling channels that prevent the device from damaging tissue. Hellstrom in view of Gertner teach the claimed invention including using a cooling fluid, but fail to explicitly claim a cooling channel being centered with and in direct contact with the LEDs. Friedman teaches that it is known to use centrally located cooling channels that are in direct contact with the LEDs as set forth in Figure 2, element 114; Figure 4, element 164 and Paragraphs 12, 54-56, 64-65 to provide enhanced cooling to prevent damage to the LED and/or injury to the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Hellstrom in view of Gertner, with the centrally located cooling channel as taught by Friedman, since such a modification would provide the predictable results of providing enhanced cooling to prevent damage to the LED and/or injury to the patient.
Regarding claim 18, meeting the limitations of claim 17 above, Hellstrom further discloses wherein the infection comprises at least one of pneumonia, a bacteria, a virus, an RNA virus, a coronavirus, or SARS-CoV-2 (e.g. ¶¶ 14, 51).
Regarding claim 19, meeting the limitations of claim 17 above, Gertner further discloses wherein the intensity comprises at least 1,100 microwatt/cm2, 1,500 microwatt/cm2, 2,000 microwatt/cm2, 2,100 microwatt/cm2, 2,200 microwatt/cm2, 2,300 microwatt/cm2, 2,400 microwatt/cm2, 2,500 microwatt/cm2, 2,600 4901-5572-6448 2 microwatt/cm2, 2,700 microwatt/cm2, 2,800 microwatt/cm2, 2,900 microwatt/cm2, 3,000 microwatt/cm2, or 2 milliwatt/cm2 (e.g. ¶¶3, 212).
Regarding claim 23, meeting the limitations of claim 17 above, Hellstrom further discloses wherein radiating the light outwardly from the ETT is performed using a UV light source integrated in a catheter, introduced inside a canal in the ETT (e.g. Figs. 3-5 and ¶18).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hellstrom in view of Gertner and Friedman as applied to claim 17 above, and further in view of Anderson et al. (U.S. Pub. 2020/0121943 hereinafter “Anderson”).
Regarding claim 21, Hellstrom in view of Gertner and Friedman discloses the claimed invention including the light illumination but is silent as to the duration of the illumination. However, Anderson teaches a similar UV therapy and states that the system provides stimulation for at least 20 minutes as set forth in Paragraph 100 and Abstract to provide substantial and reliably treatment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Hellstrom in view of Gertner and Friedman, with the duration as taught by Anderson, since such a modification would provide the predictable results of providing a duration over 20 minutes to provide substantial and reliable treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vecchio et al. (U.S. Pub. 2019/0175933) -discloses an endotracheal system with a light catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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