DETAILED ACTION
The following Office Action is in response to the Amendment filed on December 3, 2025. 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 .
Response to Arguments
Concerning the “Remarks” of the Applicant’s Response filed on December 3, 2025, 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 § 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 applicant regards as his invention.
Claims 8-13 and 31 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.
Claim 8 recites the limitation of “a plurality of stop receivers”. This limitation is already recited in claim 1, therein making it indefinite as to whether the plurality of stop receivers of claim 8 are the same as those recited in claim 1, or if they are a separate set of stop receivers. For the purposes of compact prosecution, the recitation in claim 8 will be interpreted as reading “the plurality of stop receivers”, therein defining them as the same as the stop receivers of claim 1.
Claims 9-13 are further rejected for being dependent on an indefinite claim.
Concerning claim 31, line 1 of the claim recites the limitation of “the stop receiver”. However, there is a plurality of stop receivers that have been claimed, therein making it indefinite as to whether “the stop receiver” refers to the plurality of stop receivers or just one of the stop receivers.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunkov Kunkov (US 2019/0105123).
Concerning claims 1 and 29, the Kunkov prior art reference teaches an apparatus (Figure 5A; 500) comprising a needle guide (Figure 5A; device 502 may be interpreted as a needle guide given a needle is guided into the system) including a plurality of needle guide apertures (Figure 5A; apertures located in clips 510 may be interpreted as needle guide apertures) and 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), wherein the stop locator (Figure 5A; clips 510 collectively) is carried on the needle guide (Figure 5A; 502)
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, 8-13, 15, 17, 19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouazza-Marouf et al. (US 2019/0282262) in view of Kunkov (US 2019/0105123).
Concerning claim 1, the Bouazza-Marouf et al. prior art reference teaches an apparatus (Figures 92-105; 2), comprising: a needle guide (Figure 93; 10) including a plurality of needle guide apertures (Figure 101; apparatus may include a plurality of needle supports 94 each including an aperture 96 [¶ 0464]), therein defining a plurality of needle guide apertures) and a stop locator (Figure 8; 7) wherein the stop locator includes a clip (Figure 8; structure at proximal end of stop locator may be defined as a clip) adapted to receive and hold a needle (Figure 8; 1), said clip defining a stop receiver (Figure 8; proximal face of ‘clip’ may be defined as a receiver given it may be abutted, and therein received by a stop), said stop receiver capable of receiving and positioning the stop at a desired location along the needle with the stop engaging with the clip (the stops have not been positively recited and may be of any structure), but it does not specifically teach a plurality of clips defining a plurality of stop receivers therebetween.
However, the Kunkov reference teaches a stop locator similar to that of the Bouazza-Marouf reference, wherein the Kunkov reference teaches said stop locator having 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 replace the stop locator of the Bouazza-Marouf reference with the stop locator of the Kunkov reference having a plurality of clips and defined stop receivers to provide a stop locator that better holds the needle in place to allow a provider to mark the needle (Bouazza-Marouf; [¶ 0051]).
Concerning claim 8, the combination of the Bouazza-Marouf 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 Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 8, wherein the Bouazza-Marouf reference further teaches the apparatus including a support (Figure 98; 93) adapted for mounting the needle guide to a probe.
Concerning claim 10, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 9, wherein the Bouazza-Marouf reference further teaches the support including a receiver for receiving and holding the needle guide (Figure 96; 64).
Concerning claim 11, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 10, wherein he Bouazza-Marouf reference further teaches the receiver comprising a spring clip (Figure 96; 64).
Concerning claim 12, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 11, wherein he Bouazza-Marouf reference further teaches the spring clip further including a release lever (Figure 96; 70, 74).
Concerning claim 13, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 12, wherein the Bouazza-Marouf reference further teaches a first additional needle guide ([¶ 0464], one of said different needle supports may be defined as a first additional needle support).
Concerning claim 15, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Bouazza-Marouf reference further teaches the apparatus including a support adapted for mounting the needle guide to a probe (Figure 98; 93) wherein the support includes a receiver (Figure 98; 106).
Concerning claim 17, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 8, wherein the Bouazza-Marouf reference further teaches the apparatus including an ultrasound probe (Figure 92; 4) and a support adapted for mounting the needle guide to the ultrasonic probe (Figure 93; 8).
Concerning claim 19, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Bouazza-Marouf reference further teaches the needle guide including a first section (Figure 101; 98) and a second interconnected section (Figure 101; 94) along an interface (Figure 101; 114) extending along a longitudinal axis of the needle guide and through each aperture of the plurality of needle guide apertures (Figure 101; longitudinal axis defined by channel 96).
Concerning claim 23, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claim 1, wherein the Bouazza-Marouf reference further teaches the apparatus including a support adapted for mounting the needle guide to a probe (Figure 93; 8), the support includes a receiver for receiving and holding the needle guide (Figure 93; 10), the receiver includes a socket and a cooperating spring clip (Figure 93; 28, 22) and the needle guide mounting end having a terminal projection (Figure 93; 24) adjacent a locking lug (Figure 93; 26) and when the needle guide is secured to the support, the terminal projection is engaged in the socket and the spring clip is engaged with the locking lug (Figure 92).
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouazza-Marouf et al. (US 2019/0282262) in view of Kunkov (US 2019/0105123) as applied to claims 1, 8-13, 15, 17, 19, and 23 above, and further in view of Orome et al. (US 2012/0330159).
Concerning claims 14 and 16, the combination of the Bouazza-Marouf and Kunkov references as discussed above teaches the apparatus of claims 13 and 15, but does not specifically teach the first and second additional needle guides as claimed.
However, the Orome reference teaches a needle guide similar to that of the Bouazza-Marouf reference, the Orome reference teaching a needle guide (Figure 1A; 10) including a plurality of needle guide apertures (Figure 1A; 20A-C) and 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 the needle guide structure with a first additional needle guide and a second additional guide, wherein the plurality of apertures in the needle guide are oriented at an angle A relative to the longitudinal axis of the needle guide, 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, 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 in the Orome reference to provide 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 Bouazza-Marouf et al. (US 2019/0282262) in view of Kunkov (US 2019/0105123) as applied to claims 1, 8-13, 15, 17, 19, and 23 above, and further in view of Ng (US 5,100,387).
Concerning claim 18, the combination of the Bouazza-Marouf 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 Bouazza-Marouf reference teaches that the needle is positioned in one of the plurality of apertures of the needle guide (Figure 98; 107), 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 Bouazza-Marouf and Kunkov combination as in the Ng reference to utilize the needle of the Bouazza-Marouf and Kunkov combination reference to draw fluid from a patient (Ng; Column 4, Lines 47-55).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/MARTIN T TON/Examiner, Art Unit 3771 2/27/2026