DETAILED ACTION
The following Office Action is in response to the Request for Continued Examination filed on July 13, 2026. Claims 1, 8-19, 23, 29, and 31 are currently pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 13, 2026 has been entered.
Response to Amendment
Concerning the “I. The rejections of claims 8-13 and 31 under 35 USC 112 for indefiniteness” section on page 5 of the Applicant’s Response filed on July 13, 2026, the amendments to claims 8 and 31 to address the issues of indefiniteness have obviated the necessity of the rejections of the claims under 35 U.S.C. §112(b). Therefore, the rejections are withdrawn.
Response to Arguments
Concerning the “Claim 1 and 29 are not anticipated under 35 USC 102 by US 2019/0105123 to Kunkov” section on pages 5-6 of the Applicant’s Response filed on July 13, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Concerning the “III. Claims 1, 8-13, 15, 17, 19, and 23 are patentable under 35 USC 103 over US 2019/0282262 to Bouazza-Marouf et al. when considered in view of Kunkov” section on pages 6-7 of the Applicant’s Response filed on July 13, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Concerning the “IV. Claims 14 and 16 are patentable under 35 USC 103 over Bouazza-Marouf when considered in view of Kunkov and US 2012/0330159 to Orome et al.” and “V. Claim 18 is patentable under 35 USC 103 over Bouazza-Marouf when considered in view of Kunkov and US 5,100,387 to Ng” sections on pages 7-8 of the Applicant’s Response filed on July 13, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
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, 8-11, 15, 19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai (US 2006/0009787) in view of Kunkov (US 2019/0105123, hereinafter Kunkov).
Concerning claim 1, the Tai prior art reference teaches an apparatus (Figures 1-3 and 12-17), comprising: a needle guide (Figure 1; 1) including a plurality of needle guide apertures (Figure 3; 21) and a stop locator (Figure 16; 74 | [¶ 0079]), and wherein the plurality of apertures in the needle guide are all oriented at an angle A relative to the longitudinal axis of the needle guide whereby a particular aperture of said plurality of apertures is selected to insert the needle to the desired location and depth, at the angle A, under the skin of the patient (Figure 2; each aperture 21 may be described as having an angle A even if each angle is different; angle A may simply be a variable describing an angle and the claim does not say that each angle A of each aperture must be the same), but it does not specifically teach the stop locator including a plurality of clips adapted to receive and hold a needle, said plurality of clips defining stop receivers therebetween, said stop receivers being adapted to receive and position the stops at desired locations along the needle with the stops engaging the plurality of clips at each end thereof.
However, a stop locator (Figure 5A; clips 510 collectively may be interpreted as a stop locator), wherein the stop locator includes a plurality of clips (Figure 5A; 510), wherein said clips may be interpreted as defining stop receivers therebetween (Figure 5A; proximal face of each clip 510 may be defined as a stop receiver given they may be abutted, and therein received by a stop), said stop receivers capable of receiving and positioning the stops at desired locations along the needle with the stops engaging with the clip (the stops have not been positively recited and may be of any structure).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize the stop locator of the Kunkov reference in place of the stop locator of the Tai reference as a simple substitution of one stop locator (the special stopper with positioning protrusion and position fixing knob of the Tai reference) for another stop locator (the calibration system of the Kunkov reference) which would yield the predictable result of positioning the needle at a desired location and depth under skin of a patient in the same manner with simply a different method of locating a stop at a target depth of along a needle.
Concerning claim 8, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Kunkov reference further teaches the stop locator including graduations (Figure 5A; 508) and the plurality of stop receivers at spaced apart locations along the stop locator (Figure 5A; proximal face of each clip 510 defines stop receivers).
Concerning claim 9, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 8, wherein the Tai reference further teaches a support (Figure 1; 3, 4) capable of being used to mount the needle guide to a probe depending on the structure of the specific probe.
Concerning claim 10, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 9, wherein the Tai reference further teaches the support including a receiver (Figure 1; 42) for receiving and holding the needle guide.
Concerning claim 11, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 10, wherein the Tai reference further teaches the receiver comprising a spring clip (Figure 2; 242, 243).
Concerning claim 15, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Tai reference further teaches a support (Figure 17; 3, 4) capable of mounting the needle guide to a probe, depending on the specific structure of the probe, wherein the support includes a receiver (Figure 17; 32, 42 receives plate 2, therein allowing it to be defined as a receiver).
Concerning claim 19, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Tai reference further teaches the needle guide including a first section (Figure 17; 2) and a second section (Figure 17; 23) interconnected along an interface surface along a longitudinal axis of the needle guide and through each aperture of the plurality of guide needle apertures (Figure 3).
Concerning claim 23, the combination of the Tai and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Tai reference further teaches a support (Figure 1; 3, 4) capable of being used to mount the needle guide to a probe depending on the structure of the specific probe, wherein the support includes a receiver for receiving and holding the needle guide (Figure 1; 42), the receiver includes a socket (Figure 1; 45) and a cooperating spring clip (Figure 1; 243), and the needle guide includes a mounting end (Figure 1; 4) having a terminal projection (Figure 1; distal end of 242) adjacent a locking lug (Figure 1; proximal end of 242) and when the needle guide is secured to the support, the terminal projection is engaged in the socket (Figure 1; 45) and the spring clip (Figure 1; 243) is engaged with the locking lug.
Claim(s) 1, 8-10, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orome et al. (US 2012/0330159) in view of Kunkov (US 2019/0105123, hereinafter Kunkov).
Concerning claim 1, the Orome et al. prior art reference teaches an apparatus adapted for positioning an end of a needle at a desired location and depth under skin of a patient, comprising: a needle guide (Figure 1A; 10) including a plurality of needle guide apertures (Figure 1A; 20A-C) and a stop locator (Figure 27A; 750), and wherein the plurality of apertures in the needle guide are all oriented at an angle A relative to the longitudinal axis of the needle guide whereby a particular aperture of said plurality of apertures is selected to insert the needle to the desired location and depth, at the angle A, under the skin of the patient (Figure 2; each aperture 21 may be described as having an angle A even if each angle is different; angle A may simply be a variable describing an angle and the claim does not say that each angle A of each aperture must be the same), but it does not specifically teach the stop locator including a plurality of clips adapted to receive and hold a needle, said plurality of clips defining stop receivers therebetween, said stop receivers being adapted to receive and position the stops at desired locations along the needle with the stops engaging the plurality of clips at each end thereof.
However, a stop locator (Figure 5A; clips 510 collectively may be interpreted as a stop locator), wherein the stop locator includes a plurality of clips (Figure 5A; 510), wherein said clips may be interpreted as defining stop receivers therebetween (Figure 5A; proximal face of each clip 510 may be defined as a stop receiver given they may be abutted, and therein received by a stop), said stop receivers capable of receiving and positioning the stops at desired locations along the needle with the stops engaging with the clip (the stops have not been positively recited and may be of any structure).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize the stop locator of the Kunkov reference in place of the stop locator of the Orome reference as a simple substitution of one stop locator (the needle stop feature of the Orome reference) for another stop locator (the calibration system of the Kunkov reference) which would yield the predictable result of performing in the same manner in positioning the needle at a desired location and depth under skin of a patient with a different method of locating a stop at a target depth of along a needle.
Concerning claim 8, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Kunkov reference further teaches the stop locator including graduations (Figure 5A; 508) and the plurality of stop receivers at spaced apart locations along the stop locator (Figure 5A; proximal face of each clip 510 defines stop receivers).
Concerning claim 9, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 8, wherein the Orome reference further teaches a support adapted for mounting the needle guide to a probe (Figure 4; 54).
Concerning claim 10, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 9, wherein the Orome reference further teaches the support including a receiver for receiving and holding the needle guide (Figure 4; cavity of support 54 in which head of ultrasound probe 56 is received = receiver).
Concerning claim 15, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Orome reference further teaches a support (Figure 4; 54) adapted for mounting the needle guide to a probe wherein the support includes a receiver (Figure 4; 60).
Concerning claim 17, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 8, wherein the Orome reference further teaches an ultrasonic probe (Figure 4; 50) and a support adapted for mounting the needle guide to the ultrasonic probe (Figure 4; 54).
Claim(s) 11-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orome et al. (US 2012/0330159) in view of Kunkov (US 2019/0105123, hereinafter Kunkov) as applied to claims 1, 8-10, 15, and 17 above, and further in view of Takano et al. (US 4,688,578, hereinafter Takano).
Concerning claims 11 and 12, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 10, but does not specifically teach a spring clip.
However, the Takano reference teaches a cap for an ultrasound probe (Figure 1; 80), therein being in the same field as the Orome reference, wherein the cap includes spring clips (Figure 7; 96) coupled to release levers (Figure 7; 92).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention have the support of the Orome reference include the spring clips and release levers of the Takano reference to provide an easy and speedy method of attaching the support to the probe and further providing reliable and stable attachment to the ultrasound probe (Takano; Column 2, Lines 45-60).
Concerning claims 13, 14, and 16, the combination of the Orome, Kunkov, and Takano references as discussed above teaches the apparatus of claims 11 and 15, wherein the Orome reference further teaches two alternative embodiments for the needle guide which includes needle guide channels having different angles on two different needle guides (Figures 7 & 8), and further states that the guide assembly may define different numbers and positions for the guide channels (Orome; [¶ 0055]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the apparatus include a first additional needle guide and a second additional guide, wherein a plurality of apertures in the first additional needle guide are oriented at an angle B relative to a longitudinal axis of the first additional needle guide, and a plurality of apertures in the second additional needle guide are oriented at an angle C relative to a longitudinal axis of the second additional needle guide, where angles A, B, and C are all different, and the needle guide, the first additional needle guide, and the second additional needle guide may be interchangeably connected to the receiver as a method of providing different channel depths and channel sizes for different procedures with the different needle guides (Orome; [¶ 0055]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orome et al. (US 2012/0330159) in view of Kunkov (US 2019/0105123, hereinafter Kunkov) as applied to claims 1, 8-10, 15, and 17 above, and further in view of Ng (US 5,100,387).
Concerning claim 18, the combination of the Orome and Kunkov references as discussed above teaches the apparatus of claim 17, wherein the needle is capable of carrying the plurality of stops and the needle is positioned in one of the plurality of apertures of the needle guide (Figure 6; 70), but it does not specifically teach a syringe attached to the needle.
However, the Ng reference teaches a needle guide (Figure 9; 150) for attachment to an ultrasound probe, wherein a needle may be positioned within an aperture of the needle guide (Figure 8; 10), and wherein a syringe is attached to the needle (Figure 4; 40).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a syringe be attached to the needle of the Orome and Kunkov combination as in the Ng reference to utilize the needle of the Orome and Kunkov combination to draw fluid from a patient (Column 4, Lines 47-55).
Allowable Subject Matter
Claims 29 and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MARTIN T TON/Examiner, Art Unit 3771 9/4/2026
