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 , with respect to the rejection(s) of claim(s) 1-10 under U.S.C. 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 Therefore, the rejection has been withdrawn.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 Wu et al (CN 219594827 U) in view of Nock (US20220346907A1) and further in view of Clancy et al.
Election/Restrictions
Claims 11-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/11/2026.
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.
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.
Claims 1-3, 6-7, & 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN219594827U; hereinafter referred to Wu) in view of Clancy et al (US20150360019A1; hereinafter referred to as Clancy) and further in view in view of Nock (US20220346907A1).
Regarding Claim 1, Wu discloses a medical device (“The utility model relates to the technical field of medical equipment, in particular to a lymph node body surface positioning device, which includes a syringe and a push rod.” [Abstract]), comprising:
a long, cylindrical syringe for puncture (“A lymph node body surface locating device, comprising: a needle cylinder, the needle cylinder is provided with a limiting part; a push rod,” [Pg. 2]),
a marker for tumor localization (“the marking part comprises a marking clamp and a plurality of hook claws, the marking clamp is divided into two parts, the upper half part is set as two symmetrical triangles, the lower half part is set as a hollow hemisphere, the bottom end of the hollow hemisphere is fixed with a plurality of hook claws, when the hook claw and the marking clamp are pushed into the sentinel lymph node, said alcula and sentinel lymph nodes are hooked with each other” [Pg. 2])
and a fixing device acting between the marker and the syringe (“the limiting part comprises two connecting pieces and two limiting rods respectively inserted at the bottoms of the two connecting pieces, the top parts of the two connecting pieces are fixedly connected with the two ends of the bottom surface of the fixing piece, the end parts of the two limiting rods are penetrated from the two sides of the cylinder body, the outer end of each limiting rod is provided with a pull ring capable of pulling the limiting rod.“ [Pg. 2]);
wherein the marker comprises a string and a hook portion arranged at a front end of the string (“the rod body and the inner part of the locating piece are sleeved with silk thread, the end part of the silk thread passes through the cylinder body and the needle tube and is fixedly connected with the top part of the mark clamp” [Pg. 2], “the alcula of the marking part is contacted with the sentinel lymph node and then hooked with the sentinel lymph node, the device is taken out, the marking part is left in the sentinel lymph node, and the tail end of the silk thread on the marking part is exposed out of the body, in the operation, it only needs to search the target lymph node along the silk thread,” [Pg. 3]);
a front end of the marker is inserted into the syringe, and a rear end of the marker is exposed on outside of a tail portion of the syringe (“the push rod is pushed to push the mark part into the sentinel lymph node, the hook claw of the marking part is contacted with the sentinel lymph node and then hooked with the sentinel lymph node, the device is taken out, the marking part is left in the sentinel lymph node, and the tail end of the silk thread on the marking part is exposed out of the body, in the operation, it only needs to search the target lymph node along the silk thread” [Abstract])
wherein the fixing device comprises a fixing block and upper and lower shells that are mutually clamped (“the limiting part comprises two connecting pieces and two limiting rods respectively inserted at the bottoms of the two connecting pieces, the top parts of the two connecting pieces are fixedly connected with the two ends of the bottom surface of the fixing piece, the end parts of the two limiting rods are penetrated from the two sides of the cylinder body, the outer end of each limiting rod is provided with a pull ring capable of pulling the limiting rod” [Pg. 2];
wherein the fixing block is placed on the syringe, the upper and lower shells are clamped at the tail portion of the syringe via being limited by the fixing block (‘, wherein the needle cylinder (1) comprises a cylinder body (11), and the bottom part of the cylinder body (11) is fixed with a needle tube (12), the top part of the cylinder body (11) is fixed with a fixing piece (13), the bottom part of the fixing piece (13) is provided with a limiting part, one end of the limiting part is inserted into the cylinder body (11), for limiting the sliding of the push rod (2)” [Claim 2], “wherein the limiting part comprises two connecting pieces (14) and two limiting rods (15) respectively inserted at the bottom parts of the two connecting pieces (14), the top parts of the two connecting pieces (14) are fixedly connected with the two ends of the bottom surface of the fixing piece (13), the ends of the two limiting rods (15) are penetrated from the two sides of the cylinder body (11); the outer end of each limiting rod (15) is provided with a pull ring capable of pulling the limiting rod (15).” [Claim 3]).
Wu does not specifically disclose an opening of a needle at a head portion of the syringe is beveled, the marker comprises a string of beads, wherein the string of beads is composed of a string and a plurality of beads uniformly fixed on the string and spaced apart from each other, and a contact surface of the mutually clamped upper and lower shells is provided with an elastic slot corresponding to the string of beads.
However, in a similar field of endeavor, Clancy teaches a fiducial deployment system with a handle configured for actuation of same [Abstract].
Clancy also teaches an opening of a needle at a head portion of the syringe is beveled (“The needle 800 is illustrated with a beveled distal tip 802.” [0032])
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 Wu as outlined above with an opening of a needle at a head portion of the syringe is beveled as taught by Clancy, because it is most desirable to be able to accurately target a region to be treated [0003].
Wu in view of Clancy does not specifically teach the marker comprises a string of beads, wherein the string of beads is composed of a string and a plurality of beads uniformly fixed on the string and spaced apart from each other, and a contact surface of the mutually clamped upper and lower shells is provided with an elastic slot corresponding to the string of beads.
However, in a similar field of endeavor, Nock teaches a marker delivery device includes a housing, a flexible push rod, and a wheel [Abstract].
Nock also teaches the marker comprises a string of beads, wherein the string of beads is composed of a string and a plurality of beads uniformly fixed on the string and spaced apart from each other (“As best seen in FIGS. 19 and 20, flexible push rod (716) includes a drive portion defined by a plurality of beads (718). As such, flexible push rod (716) may be referred to as a flexible beaded rod in some examples. Beads (718) are generally configured to provide an irregular drive surface, which can be engaged by beaded drive surface (787) to move flexible push rod (716). Each bead (718) comprises a protrusion having a generally spherical shape.” [0115], “Beads (718) are arranged along a length of flexible push rod (716) at equal intervals.” [0117]),
and a contact surface of the mutually clamped upper and lower shells is provided with an elastic slot corresponding to the string of beads (“Flexible push rod (516) is generally configured to be compressively rigid for deployment of marker (300), yet flexible for manipulation within housing (514). Thus, flexible push rod (516) may a variety of suitable materials having rigid, yet flexible properties. For example, flexible push rod (516) may comprise polymers, natural or synthetic rubbers, silicone, and/or etc.” [0075], “Each beaded drive surface (787) is generally configured to engage a portion of flexible push rod (716). As will be described in greater detail below, such engagement between each beaded drive surface (787) and flexible push rod (716) is configured to transfer rotatory motion of each gear (724) into translation of flexible push rod (716).” [0112], “beaded drive surface (787) of each gear (724) is generally configured to correspond to the particular shape of each bead (718). Thus, in the present example, beaded drive surface (787) includes a plurality of indentations corresponding to the particular shape of each bead (718).” [0116]).
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 Wu in view of Clancy as outlined above with the marker comprises a string of beads, wherein the string of beads is composed of a string and a plurality of beads uniformly fixed on the string and spaced apart from each other, and a contact surface of the mutually clamped upper and lower shells is provided with an elastic slot corresponding to the string of beads as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 2, Wu in view of Clancy teaches all limitations noted above except that the elastic slot is an open slot, and a silicone layer or a sponge layer covers a surface of the open slot.
However, in a similar field of endeavor, Nock teaches the elastic slot is an open slot, and a silicone layer or a sponge layer covers a surface of the open slot (“Flexible push rod (516) is generally configured to be compressively rigid for deployment of marker (300), yet flexible for manipulation within housing (514). Thus, flexible push rod (516) may a variety of suitable materials having rigid, yet flexible properties. For example, flexible push rod (516) may comprise polymers, natural or synthetic rubbers, silicone, and/or etc.” [0075], “Each beaded drive surface (787) is generally configured to engage a portion of flexible push rod (716).” [0112], “beaded drive surface (787) includes a plurality of indentations corresponding to the particular shape of each bead (718).” [0116])
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 Wu in view of Clancy as outlined above with the elastic slot is an open slot, and a silicone layer or a sponge layer covers a surface of the open slot as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 2, Wu in view of Clancy teaches all limitations noted above except that the elastic slot is an open slot, and a silicone layer or a sponge layer covers a surface of the open slot.
However, in a similar field of endeavor, Nock teaches the elastic slot is an open slot, and a silicone layer or a sponge layer covers a surface of the open slot (“Flexible push rod (516) is generally configured to be compressively rigid for deployment of marker (300), yet flexible for manipulation within housing (514). Thus, flexible push rod (516) may a variety of suitable materials having rigid, yet flexible properties. For example, flexible push rod (516) may comprise polymers, natural or synthetic rubbers, silicone, and/or etc.” [0075], “Each beaded drive surface (787) is generally configured to engage a portion of flexible push rod (716).” [0112], “beaded drive surface (787) includes a plurality of indentations corresponding to the particular shape of each bead (718).” [0116])
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 Wu in view of Clancy as outlined above with the elastic slot is an open slot, and a silicone layer or a sponge layer covers a surface of the open slot as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 3, Wu in view of Clancy teaches all limitations noted above except that at least one of fluorescent material or developing material is distributed on the marker.
However, in a similar field of endeavor, Nock teaches at least one of fluorescent material or developing material is distributed on the marker (“Marker element (12) may comprise a radiopaque or echogenic marker embedded within the bioabsorbable marker material (122) of carrier (120).” [0042])
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 Wu in view of Clancy as outlined above with at least one of fluorescent material or developing material is distributed on the marker as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 6, Wu in view of Clancy teaches all limitations noted above except that the plurality of beads are round, oval, fusiform, or cylindrical.
However, in a similar field of endeavor, Nock teaches the plurality of beads are round, oval, fusiform, or cylindrical (“Each bead (718) comprises a protrusion having a generally spherical shape. In other examples, each bead (718) can have a variety of alternative shapes such as oval-shaped, square-shaped, rectangular-shaped, elliptical-shaped, and/or etc. Additionally, although each bead (718) is shown as a protrusion in the present example, it should be understood that in other examples, the configuration of each bead (718) can be readily reversed and instead be an indentation.” [0115])
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 Wu in view of Clancy as outlined above with the plurality of beads are round, oval, fusiform, or cylindrical as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 7, Wu in view of Clancy teaches all limitations noted above except that the plurality of beads are made of heat-resistant polymeric material.
However, in a similar field of endeavor, Nock teaches the plurality of beads are made of heat-resistant polymeric material (“Flexible push rod (516) is generally configured to be compressively rigid for deployment of marker (300), yet flexible for manipulation within housing (514). Thus, flexible push rod (516) may a variety of suitable materials having rigid, yet flexible properties. For example, flexible push rod (516) may comprise polymers, natural or synthetic rubbers, silicone, and/or etc.” [0075])
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 Wu in view of Clancy as outlined above with the plurality of beads are made of heat-resistant polymeric material as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 9, Wu in view of Clancy teaches all limitations noted above except that a cavity is provided between the mutually clamped upper and lower shells for embedding and clamping the fixing block.
However, in a similar field of endeavor, Nock teaches a cavity is provided between the mutually clamped upper and lower shells for embedding and clamping the fixing block (“the interior of housing (514) includes a flexible push rod (516), a rack stowage drum (518), a spring (520), an idler gear (566), a rack drive gear (568), a deployer tip (526), and a release mechanism (528). As can be seen, annular portion (530) defines an interior surface (536), a drum aperture (538), and a spring retainer aperture (540). Interior surface (536), drum aperture (538), and spring retainer aperture (540) are together configured to contain and/or hold at least a portion of flexible push rod (516), rack stowage drum (518), spring (520), idler gear (566), rack drive gear (568), deployer tip (526), and release mechanism (528), as will be described in greater detail below.” [0074], separate cavity embodiment seen in [0128-0130])
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 Wu in view of Clancy as outlined above with a cavity is provided between the mutually clamped upper and lower shells for embedding and clamping the fixing block as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Regarding Claim 10, Wu in view of Clancy teaches all limitations noted above except that the mutually clamped upper and lower shells are provided with a fixing hole or fixing slot for embedding and clamping the fixing block.
However, in a similar field of endeavor, Nock teaches the mutually clamped upper and lower shells are provided with a fixing hole or fixing slot for embedding and clamping the fixing block (“the interior of housing (514) includes a flexible push rod (516), a rack stowage drum (518), a spring (520), an idler gear (566), a rack drive gear (568), a deployer tip (526), and a release mechanism (528). As can be seen, annular portion (530) defines an interior surface (536), a drum aperture (538), and a spring retainer aperture (540). Interior surface (536), drum aperture (538), and spring retainer aperture (540) are together configured to contain and/or hold at least a portion of flexible push rod (516), rack stowage drum (518), spring (520), idler gear (566), rack drive gear (568), deployer tip (526), and release mechanism (528), as will be described in greater detail below.” [0074], “In some examples, drum shaft (554) may be hollow and helical portion (560) may be inside drum shaft (554). First spring end (562) is retained by drum spring retainer (556) and second spring end (564) is retained by spring retainer aperture (540) (see FIG. 7).” [0082])
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 Wu in view of Clancy as outlined above with the mutually clamped upper and lower shells are provided with a fixing hole or fixing slot for embedding and clamping the fixing block as taught by Nock, because a need exists for a marker delivery device that reduces the overall length of the marker delivery device and helps an operator insertion of marker delivery device into the needle of a biopsy device [0004].
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Clancy and further in view in view of Nock as applied to Claim 1 above, and further in view of Zhang et al (CN204337013U; hereinafter referred to as Zhang)
Regarding Claim 4, Wu in view of Clancy and further in view of Nock teaches all limitations noted above except that the plurality of beads are numbered in order or at intervals.
However, in a similar field of endeavor, Zhang teaches diagnosis and treatment positioning needles, guiding sleeve stylophore and piercing assembly [Abstract].
Zhang also teaches the plurality of beads are numbered in order or at intervals (“the needle 13 is provided with spacing identification 15, and the distance identification 15 in a different color, e.g., red represents a position closest to the barb 11. green represents proper position away from barb 11, red, orange, order of yellow, green, cyan, blue, purple and other different colors, sequentially from the needle point to the needle tail identification circle graduations; specifically, distance identification as the interval Icrn of the circle, each adjacent circle divided into 10 small scales.” [0027])
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 Wu in view of Clancy and further in view of Nock as outlined above with the plurality of beads are numbered in order or at intervals as taught by Zhang, because clearly display position cautions doctors operating needle insertion depth [0027].
Regarding Claim 5, Wu in view of Clancy and further in view of Nock teaches all limitations noted above except that the plurality of beads are colored in order or at intervals.
However, in a similar field of endeavor, Zhang teaches the plurality of beads are colored in order or at intervals (“the needle 13 is provided with spacing identification 15, and the distance identification 15 in a different color, e.g., red represents a position closest to the barb 11. green represents proper position away from barb 11, red, orange, order of yellow, green, cyan, blue, purple and other different colors, sequentially from the needle point to the needle tail identification circle graduations; specifically, distance identification as the interval Icrn of the circle, each adjacent circle divided into 10 small scales.” [0027])
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 Wu in view of Clancy and further in view of Nock as outlined above with the plurality of beads are colored in order or at intervals as taught by Zhang, because clearly display position cautions doctors operating needle insertion depth [0027].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Clancy and further in view in view of Nock as applied to Claim 1 above, and further in view of Chesbrough et al (US20170119492A1; hereinafter referred to as Chesbrough)
Regarding Claim 8, Wu in view of Clancy and further in view of Nock teaches all limitations noted above except that the hook portion is cylindrical and is provided with at least one annular groove near a front end of the cylindrical hook portion.
However, in a similar field of endeavor, Chesbrough an apparatus for the percutaneous positioning of a radiopaque marker for identifying the location of a lesion in a stereotactic biopsy procedure [0003].
Chesbrough teaches the hook portion is cylindrical and is provided with at least one annular groove near a front end of the cylindrical hook portion (“FIG. 14 illustrates an eighth embodiment 130 of a radiopaque marker comprising a cylindrical body 132 in which are formed a series of axially spaced circumferential grooves 134. The spaced grooves 134 form a series of ridges 136 therebetween on the outer surface of the cylindrical body 132. The cylindrical body 132 preferably includes a hollow interior 138.” [0059], “The alternating and spaced ridges 136 and grooves 134 provide the marker 130 with a repeating diameter change along the longitudinal axis of the cylindrical body 132. As with the helical marker 120, the grooves 134 between the ridges 136 provide an area in which the tissue surrounding the marker 130 can prolapse thereby enveloping the ridges 136, which function as anchors for preventing the migration of the marker 130 in the tissue mass.” [0060], “The grooves 144 and ridges 146 of the maker 140 provide anchors in the same manner as the grooves 134 and ridges 136 of the marker 130. The anchor 150 further enhances the non-migrating characteristics of the marker 140 by permitting a large portion of the surrounding tissue mass to prolapse between the plate 150 and the cylindrical body 142.” [0062])
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 Wu in view of Clancy and further in view of Nock as outlined above with the hook portion is cylindrical and is provided with at least one annular groove near a front end of the cylindrical hook portion as taught by Chesbrough, because it prevents the marker being moved from the intended site, leading to inaccurate identification of the location of the biopsy area [0009].
Conclusion
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
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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