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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bogdanowicz et. al.'091 (U.S. Patent Publication 20220233091) in view of Kusumoto'754 (U.S. Patent Publication 20180132754).
Regarding Claim 1, Bogdanowicz et. al.'091 discloses a device comprising a member including a plurality of electroconductive segments arranged between a proximal end and a distal end of the member, wherein the plurality of electroconductive segments are electrically insulated from one another (Figure 3; Paragraph [0031] - the electrodes 206 are disposed on top of a layer of electrically insulating material 208. The electrically insulating material 208 is also located between adjacent pairs of electrodes 206. As shown, the electrically insulating material 208 encircles the needle 202 between each pair of adjacent electrodes 206. The electrically insulating material 208 can reduce contact and short circuits between adjacent electrodes 206, which could reduce the accuracy of the impedance measurements); and
at least one conduit formed in an exterior surface of the member (Paragraph [0021] - entire paragraph - In various embodiments, the electrically insulating material 208 is located between adjacent pairs of electrodes 206. As shown, the electrically insulating material 208 includes a set of carve-outs, and each of the two or more electrodes is located within one of the carve-outs of the electrically insulating material 208), and
a first conductive path including electrodes positioned in the at least one conduit, wherein a portion of the electrode is electrically coupled to a first electroconductive segment of the plurality of electroconductive segments such that the first electroconductive segment is configured as a first electrode (Paragraph [0030] - each of the electrodes 206 encircles the needle 202 at a respective location along the length of the needle 202. For example and without limitation, the first electrode 206-1 encircles the needle 202 at a first location near the needle tip 204, and the second electrode 206-2 encircles the needle 202 at a second location that is further from the needle tip 204; Paragraph [0039] - The wires 104 conduct current at various frequencies between two or more electrodes 206 and the external electrical components 106).
Bogdanowicz et. al.'091 fails to disclose a first conductive path including a wire positioned in the at least one conduit, wherein a portion of the wire is electrically coupled to a first electroconductive segment of the plurality of electroconductive segments. Kusumoto'754 teaches wires connected to each electroconductive element (Paragraph [0156] - the electrodes 50, 60 are connected by a conducting wire 52, 62 from the electrodes 50, 60 through the leads 22 to the EP mapping system 2; Paragraph [0166] - the wire 262 is merely wrapped around the exterior of the shaft 230, but could be covered with an outer insulation player, embedded within the shaft 230 or otherwise conveniently routed; Paragraph [0239] - embedded somewhat into the shaft 2220 of the needle 2200, to minimize diameter of the needle 2200. Thus, in this embodiment with much of the insulation 2222, 2224 avoided, a potential for a smaller diameter needle 2200 is provided). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Bogdanowicz et. al.'091 to include embedded wires connected to the electroconductive elements in order to route electrical signals received from the electrodes to other areas within the medical device while limiting the diameter of the device to fit in smaller areas as seen in Kusumoto'754.
Regarding Claim 2, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses comprising a second conductive path, wherein a portion of the second conductive path is electrically coupled to a second electroconductive segment of the plurality of electroconductive segments such that the second electroconductive segment is configured as a second electrode (Paragraph [0030] - each of the electrodes 206 encircles the needle 202 at a respective location along the length of the needle 202. For example and without limitation, the first electrode 206-1 encircles the needle 202 at a first location near the needle tip 204, and the second electrode 206-2 encircles the needle 202 at a second location that is further from the needle tip 204).
Regarding Claim 3, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses wherein the at least one conduit extends along at least one longitudinal portion of the member (Figure 3; Paragraph [0021] - entire paragraph - In various embodiments, the electrically insulating material 208 is located between adjacent pairs of electrodes 206. As shown, the electrically insulating material 208 includes a set of carve-outs, and each of the two or more electrodes is located within one of the carve-outs of the electrically insulating material 208. In various embodiments and without limitation, the electrodes 206 are disposed on top of the electrically insulating material 208. The electrically insulating material 208 can reduce contact and short circuits between adjacent electrodes 206, which could reduce the accuracy of the impedance measurements).
Regarding Claim 4, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses the at least one conduit is equally circumferentially arranged around the member (Annotated Figure 3 below).
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Annotated Figure 3
Regarding Claim 5, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses comprising at least one insulated segment coupled to at least one of the plurality of electroconductive segments (Paragraph [0031] - the electrodes 206 are disposed on top of a layer of electrically insulating material 208…As shown, the electrically insulating material 208 encircles the needle 202 between each pair of adjacent electrodes 206. The electrically insulating material 208 can reduce contact and short circuits between adjacent electrodes 206, which could reduce the accuracy of the impedance measurements).
Regarding Claim 6, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses the at least one insulated segment is interspersed between two electroconductive segments of the plurality of electroconductive segments (Figure 3; Paragraph [0031] - entire paragraph - The electrically insulating material 208 is also located between adjacent pairs of electrodes 206).
Regarding Claim 7, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses comprising at least one insulated segment coupled to at least one of the plurality of electroconductive segments, wherein the at least one insulated segment is interspersed between two electroconductive segments of the plurality of electroconductive segments (Figure 3; Paragraph [0031] - entire paragraph - the electrodes 206 are disposed on top of a layer of electrically insulating material 208. The electrically insulating material 208 is also located between adjacent pairs of electrodes 206).
Regarding Claim 8, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 1 above. Bogdanowicz et. al.'091 further discloses the member comprises a needle that defines a lumen (Paragraph [0030] - As shown, each of the electrodes 206 encircles the needle 202 at a respective location along the length of the needle 202; Paragraph [0032] - a needle 202 including a cannula terminating in an aperture 402).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bogdanowicz et. al.'091 (U.S. Patent Publication 20220233091) in view of Kusumoto'754 (U.S. Patent Publication 20180132754), and further in view of Ting et. al.'771 (U.S. Patent Publication 20210153771 - previously cited).
Regarding Claim 9, Bogdanowicz et. al.'091 in view of Kusumoto'754 discloses the device outlined in Claim 8 above. Bogdanowicz et. al.'091 further discloses a device configured to remove a substance through a cannula (Paragraph [0037] - For example and without limitation, in various embodiments in which the needle 202 is included in a tissue extraction tool, the cannula of the needle 202 can receive and store a tissue sample of tissue that is penetrated by the needle tip 204; Paragraph [0038] - As another example and without limitation, the first cannula can perform one or more operations, such as delivering a therapeutic drug or energy or extracting a tissue sample, and the second cannula can include two or more electrodes are disposed on an interior surface of the second cannula; Paragraph [0044] - For example and without limitation, in various embodiments in which the needle 202 is included in a tissue sample extraction tool, the processor 506 can perform operations 514 that include activating the tissue sample extraction tool to extract a tissue sample from the tissue at the location 102 associated with the needle 202), but fails to disclose comprising a suction device configured to remove a substance through the lumen. Ting et. al.’771 teaches a device comprising a suction device configured to remove a substance through a lumen (Paragraph [0201] - a biopsy sample can be obtained from the subject through the lumen; Paragraph [0209] - by extracting or aspirating the targeted fluid, materials, compounds, agents, enzymes, fillers, fluids, etc. This can be done, in one non-limiting example, by…pulling back on the syringe plunger to create suction or a vacuum that draws the targeted fluid, materials, cells, compounds, agents, enzymes, fillers, fluids, etc. into the syringe (e.g., in a reverse direction)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Bogdanowicz et. al.'091 in view of Kusumoto'754 to include a suction device connected to the cannula of the medical device in order to assist in removing biopsy samples from targeted areas as seen in Ting et. al.’771.
Response to Arguments
Applicant's arguments filed 26 June 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior drawing objections.
Applicant’s amendments have overcome the prior specification objections.
Claims 1-9 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 3-4 above. The examiner has considered the applicant's arguments regarding Ting et. al.'771 failing to disclose a conduit and a conductive path as separate elements. The examiner has cited additional prior art that they believe discloses the amended limitations when in combination with one another.
The examiner has considered the applicant’s arguments pertaining to rejoining, but these arguments were found to be not persuasive. As claim 1 is not in condition for allowance, claims 10-20 have not been rejoined.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Edwards et. al.’389 (U.S. Patent 5607389) discloses a biopsy devices comprising embedded electrode wires.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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