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 .
Response to Arguments
Applicant's arguments filed 3/25/26 have been fully considered but they are not persuasive. The Applicant argues that states that the references fail to show LEDs that emit UV-A, a cooling tube with at least one opening, an ETT connector disposed at the proximal end and the light catheter deployed into the ETT to a desired length within the catheter. The Examiner respectfully disagrees. As previously noted in the prior action and shown below, Vazales clearly shows, LEDs that emit UV (e.g. ¶¶111, 424), an ETT connector at the proximal end of the light catheter that connects to the ETT when the light catheter is deployed to its desired length (e.g. ¶¶ 62, 64, 123, 26, 161). It is further noted that Vazales discloses the LEDs are located at the distal end of the catheter and fails to show that the LEDs are located at the proximal end of the catheter near the ETT connector. However, Gertner teaches that it is known in the art to use LEDs that emit UV-A light and are 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. It is further noted that the Applicant argues that Gertner fails to disclose a cooling tube with an opening towards the proximal end. The Examiner would like to direct that Applicant to the cited paragraph 173 that clearly discloses the cooling tubes and openings that are at the proximal end near the handle. The Applicant further argues that the light catheter fails to suggest or disclose that the light catheter is configured to be deployed into the ETT such that a desired length is positioned within the ETT. The Examiner respectfully disagrees. As cited in the prior action and below again, Paragraphs 62, 64, 123, 26, 161 clearly show that the light catheter is positioned within the ETT to the scope retention (ETT connector) depth and then locked to the ETT device thereby maintaining distal tip at the desired depth and locking the device in axial relation with the ETT. The Applicant argues that there is no disclosure that the ETT connector is disposed at a proximal location. The Examiner respectfully disagrees. The scope retention is clearly shown to be located at the proximal end of the light catheter. Therefore, since Vazales in view of Gertner teach each and every limitation as previously cited, the rejection stands.
Regarding claims 24-25, the Applicant argues that the device of Gertner fails to show a cooling tube that exits through the proximal portion of the device. The Examiner respectfully disagrees. The Examiner would like to direct that Applicant to the cited paragraph 173 that clearly discloses the cooling tubes and openings that are at the proximal end near the handle. Further the claims are silent to the degree of flexibility of the cooling tubes. The materials used in the cooling tubes have a degree of flexibility that meet the claimed limitations. Therefore, the rejections of claims 24-25 stand.
The Applicant further argues that claim 26 is allowable as the combination of references fails to disclose that the light catheter is configured to be inserted into the ETT and the catheter is houses in the protective sleeve when not inserted. The Examiner respectfully disagrees. The combination of references clearly shows that the light catheter is configured to be inserted and deployed within the ETT. Further the catheter has a protective sleeve over it (¶¶156, 171, 173). It is noted that device of Vazales in view of Gertner is disposed in the sleeve when inserted and when not inserted.
Regarding claims 17-19 and 23, the arguments are similar to those of claims 21 above regarding the Gertner reference and the arguments are the same as above regarding the Gertner reference.
It is noted that based on the Applicants arguments, it appears that the Applicant is claiming the embodiment shown in figures 65-66 of the application. In the description of figures 65-66 the description uses proximal for what normally would be considered distal. For example, Paragraph 227 states that the proximal end 6520 includes the ETT connector 6649. However, 6520 shows the distal end of the device which is the farthest from the point of origin of the device. Therefore, it appears as if the Applicant is trying to redefine the term proximal to mean the exact opposite of its ordinary meaning. It is noted that the written description asserts that the proximal end is the opposite of the known definition of the term, however, it is not clearly defined. Therefore, the rejections of the claims are using the term proximal to mean that the claimed limitation is closest to the point of origin and distal is farthest away from the point of origin. Clarity on this issue, from the Applicant, is required and would help in moving this case toward allowance.
Finally, The Applicant further argues that the finality of the next action is precluded as the Examiner did not consider all of the claim limitations. The argument is erroneous and moot for the reasons as discussed in detail above. All of the limitations were considered and rejected. Therefore, since all of the claims stand rejected this action is final.
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”).
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.
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 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 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, 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 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 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, 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 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 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, 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 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 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, 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”).
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.
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 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 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, 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
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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