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 .
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Claims 11-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device, there being no allowable generic or linking claim.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, & 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mcweeney et al (US20160206294A1; hereinafter referred to as Mcweeney) in view of Clancy et al (US20150360019A1; hereinafter referred to as Clancy).
Regarding Claim 1, Mcweeney discloses a medical device (“The invention provides device for needle biopsy that includes a novel delivery handle system for interchangeably delivering needles of various sizes to a biopsy site.” [Abstract]), comprising:
a long, cylindrical syringe for puncture (“The needle sub-assembly 15 consists of the needle shaft 21 (which can range in length from 500 mm up to 2500 mm, but which more preferably ranges in length between 1640 mm to 1680 mm) and is beveled at the distal needle end to enhance tissue penetration” [0070]),
a marker for tumor localization (“the distal end of the needle of the present invention incorporates an embodiment to enhance the echogenic signature of the needle. In the case of the present invention, this echogenically enhanced region 34 can be fabricated by, but not limited to roughening the end of the needle over a pre-defined length close to proximal end of the needle bevel 35. It is preferable that the length of this echogenically enhanced region 34 be in the range of 2 mm to 20 mm, but is more preferably in the range of 10 mm to 15 mm. In the case of the present invention, the echogenic enhanced pattern is imparted to the needle via a micro-blasting process which roughens the surface of the needle over a specific length, improving the visibility of the needle under endoscopic ultrasound.” [0087])
and a fixing device acting between the marker and the syringe (“The needle protection sub-assembly 9 consists of two needle protector (NP) hub halves (collectively 23), which are adhesively bonded to each other, on the proximal end of the needle protector (NP) sheath component 24. Alternately, these NP hub halves 23 may be snap fit together or may be insert injection molded over the NP sheath 24 to provide a secure bond / attachment between these components in the assembly. “ [0073]);
wherein an opening of a needle at a head portion of the syringe is beveled (“The needle sub-assembly 15 consists of the needle shaft 21 (which can range in length from 500 mm up to 2500 mm, but which more preferably ranges in length between 1640 mm to 1680 mm) and is beveled at the distal needle end to enhance tissue penetration” [0070]);
wherein the fixing device comprises a fixing block and upper and lower shells that are mutually clamped (“The needle protection sub-assembly 9 consists of two needle protector (NP) hub halves (collectively 23), which are adhesively bonded to each other, on the proximal end of the needle protector (NP) sheath component 24. Alternately, these NP hub halves 23 may be snap fit together or may be insert injection molded over the NP sheath 24 to provide a secure bond / attachment between these components in the assembly. “ [0073]);
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, and a contact surface of the mutually clamped upper and lower shells is provided (“The proximal handle member of the delivery handle system of the invention includes an inner retention collar disposed at a distal end of the inner hub housing component. The inner retention collar is configured to receive the needle protection hub coupled to the needle. At least a portion of the retention collar is recessed, and the deformable O-ring component is disposed within the recessed portion for securing the needle protection hub within the retention collar upon insertion of the needle subassembly into the proximal handle member.” [0027]).
Mcweeney does not specifically disclose a localization and marking device with a beaded structure, wherein the marker comprises a string of beads and a hook portion arranged at a front end of the string of beads, 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; 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 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 a localization and marking device with a beaded structure (“The fiducial 400 has a generally cylindrical body 402 formed as a mass with a generally circular transverse cross-section along its proximal and distal end sections. A protuberance 408 projects from the longitudinal circumferential face 406 of the fiducial body 402. As viewed from the top, the protuberance 408 is generally obround. The irregular shape and increased surface area (as compared to a typical cylindrical fiducial of the type used in plug-ended systems and/or systems with some type of lumen-occupying detent) preferably enhances the echogenicity of the fiducial, which preferably will already be desirably high due in part to its composition.” [0028]),
wherein the marker comprises a string of beads and a hook portion arranged at a front end of the string of beads (“The protuberance 408 includes protuberance end faces 407 that may provide one or more of chamfered, filleted, and radiused transition to the outer face 406 of the body 402. The body 402 is generally a right cylinder, but for the protuberance 408.” [0029], “For circumstances where it may be advantageous to minimize migration, a fiducial may be used that includes one or more anchoring projections” [0048]),
a front end of the marker is inserted into the syringe (“FIGS. 1A and 1B show longitudinal sectional views of a two-piece introducer 100 of the prior art useful for placement of brachytherapy seeds or fiducials. Referring first to FIG. 1A, the introducer 100 includes a needle 102 and a stylet 104 slidably disposed within the needle 102. The stylet 104 includes a first handle 101 and a blunt distal end 106. The needle 102 includes a second handle 103 and a bevel-tipped cannula 108 extending through the second handle 103.“ [0008]) ,
and a rear end of the marker is exposed on outside of a tail portion of the syringe (“FIGS. 1A and 1B show longitudinal sectional views of a two-piece introducer 100 of the prior art useful for placement of brachytherapy seeds or fiducials. Referring first to FIG. 1A, the introducer 100 includes a needle 102 and a stylet 104 slidably disposed within the needle 102. The stylet 104 includes a first handle 101 and a blunt distal end 106. The needle 102 includes a second handle 103 and a bevel-tipped cannula 108 extending through the second handle 103.“ [0008]);
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 will be appreciated from the structure of the needle 800 and fiducials 400 as shown in FIGS. 4-4B, a user preferably will be able to control advancement/deployment of the fiducials to one at a time, such that a plurality of fiducials (without any spacers) may serially—but separately and independently—directed into different locations. Then the fiducial 400 is in a “ready to deploy” position, its distal protuberance face 408 a is engaged against the proximal tab edges 808 a.” [0043]);
and an elastic slot corresponding to the string of beads (“The central longitudinal body portion 402 substantially occupies the inner diameter of the needle lumen 810. The protuberance 408 of each fiducial 400 has a height that may be about the same as the thickness of the needle wall, including the slot 806 into which the protuberances 408 project.” [0036].
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 Mcweeney as outlined above with a localization and marking device with a beaded structure, wherein the marker comprises a string of beads and a hook portion arranged at a front end of the string of beads, 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; 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 an elastic slot corresponding to the string of beads as taught by Clancy, because it is most desirable to be able to accurately target a region to be treated [0003].
Regarding Claim 3, Mcweeney discloses 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, Clancy teaches at least one of fluorescent material or developing material is distributed on the marker (“Such a fiducial 400 preferably will be formed of a radio-opaque, non-ferromagnetic material such as, for example, gold, platinum, palladium, iridium, or alloys thereof, with one preferred embodiment including an alloy of palladium with rhenium (advantages of which may include desirable radio-opacity” [0025]).
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 Mcweeney as outlined above with at least one of fluorescent material or developing material is distributed on the marker as taught by Clancy, because it is most desirable to be able to accurately target a region to be treated [0003].
Regarding Claim 4, Mcweeney discloses all limitations noted above except that the plurality of beads are numbered in order or at intervals.
However, in a similar field of endeavor, Clancy teaches the plurality of beads are numbered in order or at intervals (“As the plunger member 1770 is depressed, the rotationally driven indicator dial 1776 rotates transversely to the handle such that the numerical indicia 1778 that can be seen through the window 1774 formed in the body of the handle member body 1754 rotates to a second numerical indicia corresponding to the information about the distance advanced by the stylet's distal end from actuation of the plunger member 1770. In certain preferred embodiments, the numerical value displayed indicates the number of fiducials that have been deployed from the distal end of the needle.” [0058]).
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 Mcweeney as outlined above with the plurality of beads are numbered in order or at intervals as taught by Clancy, because it is most desirable to be able to accurately target a region to be treated [0003].
Regarding Claim 5, Mcweeney discloses all limitation noted above except that the plurality of beads are colored in order or at intervals.
However, in a similar field of endeavor, Clancy teaches the plurality of beads are colored in order or at intervals (“Numerical indicia 1778 (which in other embodiments may be colored bands or other similar visual indicia) may be used to provide a visual cue to the user allowing the user to identify information about the distance advanced by the stylet's distal end.” [0057]).
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 Mcweeney as outlined above with the plurality of beads are colored in order or at intervals as taught by Clancy, because it is most desirable to be able to accurately target a region to be treated [0003].
Regarding Claim 6, Mcweeney discloses all limitation noted above except that the plurality of beads are round, oval, fusiform, or cylindrical.
However, in a similar field of endeavor, Clancy teaches the plurality of beads are round, oval, fusiform, or cylindrica (“A protuberance 408 projects from the longitudinal circumferential face 406 of the fiducial body 402. As viewed from the top, the protuberance 408 is generally obround.” [0028]).
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 Mcweeney as outlined above with the plurality of beads are round, oval, fusiform, or cylindrica as taught by Clancy, because it is most desirable to be able to accurately target a region to be treated [0003].
Regarding Claim 8, Mcweeney discloses all limitation 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, Clancy teaches (“A longitudinal surface face of the body may be dimpled to enhance its ability to reflect ultrasound waves and thereby provide a desirable echogenic profile. This dimpled characteristic may alternatively be embodied as a different irregular, patterned, or textured surface feature (e.g., knurled, ribbed) that may enhance the echogenicity of the fiducial 400, which will aid in visualizing it during EUS-guided placement, and allow it to be used in ultrasound visualization of a target site being marked by one or more fiducials 400 (e.g., a tumor).” [0024])
Regarding Claim 9, Mcweeney discloses a cavity is provided between the mutually clamped upper and lower shells for embedding and clamping the fixing block (“The proximal portion of the proximal handle member 10a of the delivery system handle 10, incorporates a retention collar 29 and a retention collar O-ring component 30. The retention collar component 29 resides in a cut out nest in the proximal handle half, and is in communication with inner hub housing component 27.” [0080]).
Regarding Claim 10, Mcweeney discloses the mutually clamped upper and lower shells are provided with a fixing hole or fixing slot for embedding and clamping the fixing block (“The proximal portion of the proximal handle member 10a of the delivery system handle 10, incorporates a retention collar 29 and a retention collar O-ring component 30. The retention collar component 29 resides in a cut out nest in the proximal handle half, and is in communication with inner hub housing component 27.” [0080]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mcweeney in view of Clancy as applied to Claim 1 above, and further in view of Cortez et al (US20220265426A1; hereinafter referred to as Cortez).
Regarding Claim 2, Mcweeney in view of Clancy teaches the elastic slot is an open slot (“ Its tubular cannula body 804 includes a longitudinal needle slot 806 along a distal end region of the cannula 804. The slot 806 preferably includes at least one detent including at least one detent surface, and more preferably two detents. The slot 806 is shown as being open through the entire wall of the cannula 804, but it should be appreciated that the slot may extend less than the thickness of the needle wall, such that it is embodied as a groove.” [Clancy 0032]),
Mcweeney in view of Clancy does not specifically teach a silicone layer or a sponge layer covers a surface of the open slot.
However, in a similar field of endeavor, Cortez A medical device shaft with echogenic additives associated with at least one of the elongate shaft and the end effector [Abstract].
Cortez also teaches a silicone layer or a sponge layer covers a surface of the open slot (“Examples of particulates/additives that may be implemented in connection with embodiments of the present disclosure include, but are not limited to, white pigment, micro balloons, glass beads, or the like, which may be embedded at least partially within silicone or other similar material, which may be used as a covering and/or form for a shaft and/or end effector” [0262]).
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 Mcweeney in view of Clancy as outlined above with a silicone layer or a sponge layer covers a surface of the open slot as taught by Cortez, because it may provide desirable echogenicity characteristics [0262].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mcweeney in view of Clancy as applied to Claim 1 above, and further in view of Harmer et al (US 20140018663 A1; hereinafter referred to as Harmer).
Regarding Claim 7, Mcweeney in view of Clancy discloses all limitations noted above except that the plurality of beads are made of heat-resistant polymeric material.
However, in a similar field of endeavor, Harmer teaches a method and apparatus for preparing tissue of interest in a patient for possible excision by surgery [Abstract].
Harmer also teaches the plurality of beads are made of heat-resistant polymeric material (“a tissue marker is provided comprising bioabsorbable polymer beads loaded with superparamagnetic MNPs. The beads can, for example, be inserted during a breast biopsy.” [0039], “As well as coating to enhance biocompatibility, MNPs are often coated in order reduce toxicity, prevent agglomeration of the particles, or to modify their residence time in the body. Coating materials are typically natural or synthetic polymers including dextrans, carboxydextrans, Poly ethylene glycol (PEG), Poly vinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethyleneimine (PEI), polyglucose sorbitol carboxymethylether and chitosan. Other coating materials include metals such as gold, pegylated colloidal gold nanoparticles, silver; carbon, silica, silicones, aminosilanes and ceramics.” [0031]).
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 Mcweeney in view of Clancy as outlined above with the plurality of beads are made of heat-resistant polymeric material as taught by Harmer, because a need remains for a means for marking non-palpable lesions which avoids the drawbacks of the current techniques [0010].
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
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
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