CTNF 19/185,421 CTNF 98747 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement 06-49-07 AIA The information disclosure statement filed 09/29/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Griffiths et al (US20080147147A1; hereinafter referred to as Griffiths) in view of Wung et al (US5623931A; hereinafter referred to as Wung) . Regarding Claim 1 , Griffiths discloses a method of guiding a needle into and illuminating a blood vessel or graft in a subject (“This invention relates generally to vein locating or vein visualization devices, and more specifically to devices that use near-infrared (NIR) or ultrasound energy to locate or visualize venous structures in patients.” [0001]), the method comprising: inserting a needle guide insert comprising a needle guide into a base of a housing of a trans-illuminating needle guide device (“A key component of the vein finding device 10, 110, 210 is a per-patient sterile disposable coupler/needle guide 350, as shown in FIG. 5. The disposable coupler 350 fits over the patient contact end 135 (shown also in FIG. 2) of the device” [0035], “Further, the housing 112 of the device 110 may also include one or more visible light illuminating sources 134, such as LEDs, which are disposed to be near the surface 118 of the skin, so that visual detection of near-surface veins is facilitated and/or improved.” [0030]); placing the trans-illuminating needle guide device on a skin surface of the subject (“Once the device has been activated, it is placed on the patient's skin, so that the disposable coupler 350 is in contact with the skin surface.” [0038]); illuminating the skin surface of the subject using a plurality of light emitting diodes (LEDs) disposed within the housing of the trans-illuminating needle guide device, thereby locating the blood vessel or graft beneath the skin surface (“the housing 112 of the device 110 may also include one or more visible light illuminating sources 134, such as LEDs, which are disposed to be near the surface 118 of the skin, so that visual detection of near-surface veins is facilitated and/or improved.” [0030]); adjusting the needle guide (“The coupler 350 may contain multiple guides so that it can be used for a variety of needle entry angles, depending on the type of IV access to be performed.” [0035]); inserting the needle into a channel of the needle guide to guide the needle, inserting the needle into the blood vessel or graft (“the coupler 350 may include an integral needle guide 354 so that once the vein is located the operator may insert a catheter 356 or introducer needle (in the case of PICC lines) so that it is guided towards the vein identified by the device” [0035]); and disengaging the needle from the needle guide (“Once the vein has been located and/or the IV needle placed, the device 10, 110, 210 may be turned off and the disposable coupler 350 discarded.” [0039]). Griffiths does not specifically disclose selecting a needle insertion depth by adjusting the needle guide, at the selected needle insertion depth. However, in a similar field of endeavor, Wung teaches a disposable/reusable needle guide which can be: (a) utilized with many ultrasound probes; (b) attached and detached from such ultrasound probes easily and rapidly; and (c) utilized with biopsy needles. Wung also teaches selecting a needle insertion depth by adjusting the needle guide, at the selected needle insertion depth (“As further shown in FIG. 4, needle support 130 is further comprised of grooves 610, 620, and 630 for supporting needles. The three grooves are used to support a needle at three different angles for use in performing differing surgical procedures or for providing penetration of a needle to a different depth within a patient's body.” [Pg. 6 Col. 3 Lines 39-44]) It would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Griffiths as outlined above with selecting a needle insertion depth by adjusting the needle guide, at the selected needle insertion depth as taught by Wung, because it allows for performing differing surgical procedures or for providing penetration of a needle to a different depth within a patient's body [Pg. 6 Col. 3 Lines 42-44] 07-22-aia AIA Claim s 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Griffiths in view of Wung as applied to Claim 1 above, and further in view of Butcher et al (US20100125283A1;hereinafter referred to as Butcher) . Regarding Claim 2 , Griffiths in view of Wung discloses all limitations noted above except that selecting the needle insertion depth further comprises moving: i) a first deflectable plate of the needle guide along a first angled slot defined by a side wall of the needle guide insert, and ii) a second deflectable plate of the needle guide along a second angled slot and a groove of a plurality of grooves defined by the side wall of the needle guide insert. However, in a similar field of endeavor, Butcher teaches a universal needle guide comprising a body, a first needle aperture and a second needle aperture [Abstract]. Butcher also teaches that selecting the needle insertion depth further comprises moving: i) a first deflectable plate of the needle guide along a first angled slot defined by a side wall of the needle guide insert, and ii) a second deflectable plate of the needle guide along a second angled slot and a groove of a plurality of grooves defined by the side wall of the needle guide insert (“FIG. 4 is another embodiment of a universal needle guide 210 having at least one sliding plate. In FIG. 4 an upper support portion 214 is defined by a bottom surface 232 and two side surfaces 234 and 236. The first plate 202 is positioned within the upper support portion 214 such that the first plate 202 abuts the bottom surface 232 and the two side surfaces 234 and 236, but does not extend the height of the side surfaces 234 and 236. The first plate 202 also has a substantially v-shaped notch 226 centered on a top surface 204 of the first plate 202 and extending downwardly therefrom. A second plate 206 may also have a complimentary v-shaped notch 244 centered on the bottom surface 208 of the second plate 206 and extending upwardly therefrom. However, it is understood that the v-shaped notch 244 of the second plate 206 may be omitted. The second plate 206 is slidably engaged with the side surfaces 234 and 236 of the upper support portion 214.” [0029], “the second plate 206 may include at least one locking tab 216 on at least one side 218 of second plate 206 to lock second plate 206 in a specific position. The locking tab 216 is positioned complementary to a plurality of notches 220 on at least one of side surfaces 234 and 236; however, other types of locking mechanisms could be used.” [0030]). It would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Griffiths in view of Wung as outlined above with selecting the needle insertion depth further comprises moving: i) a first deflectable plate of the needle guide along a first angled slot defined by a side wall of the needle guide insert, and ii) a second deflectable plate of the needle guide along a second angled slot and a groove of a plurality of grooves defined by the side wall of the needle guide insert as taught by Butcher, because it allows the universal needle guide to support a larger needle gauge [0030]. Regarding Claim 3 , Griffiths discloses all limitations noted above except that each groove of the plurality of grooves corresponds to a different needle insertion depth. However, in a similar field of endeavor, Wung teaches that that each groove of the plurality of grooves corresponds to a different needle insertion depth (“As further shown in FIG. 4, needle support 130 is further comprised of grooves 610, 620, and 630 for supporting needles. The three grooves are used to support a needle at three different angles for use in performing differing surgical procedures or for providing penetration of a needle to a different depth within a patient's body.” [Pg. 6 Col. 3 Lines 39-44]) It would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Griffiths as outlined above with selecting a needle insertion depth by adjusting the needle guide, at the selected needle insertion depth as taught by Wung, because it allows for performing differing surgical procedures or for providing penetration of a needle to a different depth within a patient's body [Pg. 6 Col. 3 Lines 42-44] Regarding Claim 4 , Griffiths in view of Wung discloses all limitations noted above except that inserting the needle guide insert further comprises: compressing the first and second deflectable plates towards each other. However, in a similar field of endeavor, Butcher teaches that inserting the needle guide insert further comprises: compressing the first and second deflectable plates towards each other (“FIG. 4 is another embodiment of a universal needle guide 210 having at least one sliding plate. In FIG. 4 an upper support portion 214 is defined by a bottom surface 232 and two side surfaces 234 and 236. The first plate 202 is positioned within the upper support portion 214 such that the first plate 202 abuts the bottom surface 232 and the two side surfaces 234 and 236, but does not extend the height of the side surfaces 234 and 236. The first plate 202 also has a substantially v-shaped notch 226 centered on a top surface 204 of the first plate 202 and extending downwardly therefrom. A second plate 206 may also have a complimentary v-shaped notch 244 centered on the bottom surface 208 of the second plate 206 and extending upwardly therefrom. However, it is understood that the v-shaped notch 244 of the second plate 206 may be omitted. The second plate 206 is slidably engaged with the side surfaces 234 and 236 of the upper support portion 214.” [0029], “the second plate 206 may include at least one locking tab 216 on at least one side 218 of second plate 206 to lock second plate 206 in a specific position. The locking tab 216 is positioned complementary to a plurality of notches 220 on at least one of side surfaces 234 and 236; however, other types of locking mechanisms could be used.” [0030]). It would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Griffiths in view of Wung as outlined above with inserting the needle guide insert further comprises: compressing the first and second deflectable plates towards each other as taught by Butcher, because it allows the universal needle guide to support a larger needle gauge [0030]. Conclusion 07-96 The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (US20240050122A1). Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th 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, Christopher Koharski can be reached on (571) 272-7230. 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. /Steven Maldonado/ Patent Examiner, Art Unit 3797 /CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797 Application/Control Number: 19/185,421 Page 2 Art Unit: 3797 Application/Control Number: 19/185,421 Page 3 Art Unit: 3797 Application/Control Number: 19/185,421 Page 4 Art Unit: 3797 Application/Control Number: 19/185,421 Page 5 Art Unit: 3797 Application/Control Number: 19/185,421 Page 6 Art Unit: 3797 Application/Control Number: 19/185,421 Page 7 Art Unit: 3797
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