DETAILED ACTION
This action is pursuant to claims filed on 10/15/2025. Claims 1-3 and 5-10 are pending. A final action on the merits of claims 1-3 and 5-10 is as follows.
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
Applicant’s election without traverse of the species of Fig. 5 in the reply filed on 6/11/2025 is acknowledged. Claims 1-3 and 5-10 are pending. Claims 4 and 11-20 have been cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 10 is rejected because it introduces a “plurality of retractable tines” that are a separate entity from the “segmenting wires” that “extend at an angle of less than 90 degrees.” The applicant has pointed to paragraph [00112] of the specification to show support for the segmenting wires extending at an angle of less than 90 degrees. That paragraph specifically states that “a plurality of tines extending from the distal end of the tube at an angle (e.g., <90 degrees). This indicates that the plurality of tines are in fact part of the segmenting wires, not a separate entity. Claim 10 introduces the plurality of tines as a separate entity from the segmenting wires as it states “the tissue segmentation device of claim 1, further comprising: a plurality of retractable tines.” As the claim is written, these must be separate from the extendable segmentation wires. Thus, because claim 1 requires the segmentation wires to extend at an angle of less than 90 degrees and the applicant points to the portion of the specification and drawings which highlight the tines as the part of the segmenting wires that accomplish this task, the plurality of tines claimed in claim 10 must be different from those of claim 1. There is not support for multiple groupings of tines in the original disclosure of the instant application. Therefore, a plurality of tines, which are a different entity from the segmenting wires, lacks support in the original disclosure and is thus considered new matter and fails to comply with the written description requirement.
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.
Claim 10 is 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 10 is rejected because it introduces a “plurality of retractable tines” that are a separate entity from the “segmenting wires” that “extend at an angle of less than 90 degrees.” This limitation makes the scope of the invention indefinite because it appears to introduce a plurality of tines that are separate from the segmenting wires which extend at an angle of less than 90 degrees. Based on the specification, specifically paragraph [00112], the tines are actually a part of the segmenting wires, not an entirely separate entity. Therefore, because it is indefinite whether the tines are part of the segmenting wires or not, the claim is rejected. For the purposes of compact prosecution, the plurality of tines will be treated as integral to the segmenting wires.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al. (hereinafter ‘Bales’, US 6494881 B1) in view of Batchelor et al. (hereinafter ‘Batchelor’, US 20150126998 A1).
Regarding independent claim 1, Bales discloses a tissue segmentation device (device 100 shown in Fig. 12), comprising:
one or more segmenting wires (segmenting wires 106 and 108 shown in Fig. 14; [Col 8, lines 15-29]: 106 and 108 are connected by wire leads that extend through insulator jackets 110 and 112 to connect to the electrical contact ring – thus the wire leads and electrodes form the segmenting wires);
a grasper (a grasper is shown in Fig. 33 for the removal of a sample);
an introducer tube (sheath 101 in Fig. 12) having a proximal end and a distal end (proximal end closest to the handle and distal end closest to the end effectors), wherein the introducer tube is shaped and sized to allow introduction of the one or more segmenting wires (segmenting wires are introduced through the sheath 101 as seen in Fig. 12) into an incision in a patient (inserted into patient as seen in Fig. 21); and
at least one actuator positioned at or near the proximal end of the introducer tube (ring 128 and thumb piece 126a shown in Fig. 12), wherein the at least one actuator is coupled to a proximal portion of the one or more segmenting wires ([Col 9, lines 51-67]: actuator advances the wires);
wherein at least one of the one or more segmenting wires extends at an angle of less than 90 degrees from the distal end of the introducer tube (as seen in Figs 13 and 21b, the segmenting wires that are within the insulation 110 and 112 forming electrodes 106 and 108 extend outward and at a slight downward angle from the introducer tube – extend is a broad term and these extend outward at an angle of less than 90 degrees, the claim does not limit the shape of the ends of the wires, only the direction in which they extend), and
a grasper actuator (handle of grasper shown in Fig. 33a) which actuates the grasper to grasp the sample ([Col 16, lines 53-60]).
However, Bales is silent to the grasper being introduced through the same introduction tube as the segment wires and the grasper being used to manipulate the tissue into the at least one of the one or more segmenting wires and for contact by at least one of the one or more segmenting wires prior to or during the tissue segmentation.
Batchelor teaches an electrosurgical system that includes a grasper and a snare which output electrosurgical energy for the removal of tissue ([Abstract]). Batchelor further teaches that the snare and the grasper can be introduced through a single cannula ([0033]). Introducing the grasper and the snare in close proximity with one another allows current to be conducted through the electrical circuit between the grasper and the snare, which enables precise control of the size of the electrode area ([0034]). Furthermore, utilizing the grasper in close proximity to the snare allows for the grasper to manipulate the tissue for contact with the snare as seen in Fig. 2. Adding a conductive grasper through the same cannula is of routine skill in the art and Bales contemplates the use of a conductive grasper to aid in the procedure, meaning that utilizing the electrical benefits of Batchelor would not render Bales inoperable ([Col 16, lines 53-60]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the grasper and cannula of Batchelor with the device of Bales such that the grasper is introduced through the same sleave as the segmenting wires which would place them in close proximity for more precise control of the electrode area and allow for manipulation of the tissue to the segmenting wires for segmentation.
Regarding claim 2, the Bales/Batchelor combination discloses the tissue segmentation device of claim 1, wherein the one or more segmenting wires comprise a plurality of segmenting wires (two segmenting wires 106 and 108 in Fig. 14 of Bales) and wherein the at least one of the plurality of segmenting wires is an active electrode configured to carry radio frequency (RF) energy ([Col 7, lines 39-60]: the loop electrode 106 is the hot electrode for delivery of energy to the area – the wire that connects the electrical contact and the electrode is also active).
Regarding claim 3, the Bales/Batchelor combination discloses the tissue segmentation device of claim 2, wherein the active electrode is a stationary electrode (active electrode 106 is stationary as it only deploys and retraces from the distal end of the actuator instrument and does not change size or move in any other direction, which is consistent with the instant application paragraph [00109]), and the grasper comprises a return electrode (Batchelor [0033]: the grasper can comprise the return electrode), and wherein the manipulation of the grasper comprises pulling the tissue specimen into the active electrode for segmentation of said tissue specimen (Batchelor [0033]: the grasper can manipulate the tissue for segmentation, also seen in Fig. 2).
Regarding claim 5, the Bales/Batchelor combination discloses the tissue segmentation device of claim 2, wherein, at least a portion of the grasper is conductive, the grasper comprises a return electrode (Batchelor [0033]: the grasper can comprise the return electrode), the active electrode comprises a single active electrode (Bales [Col 7, lines 39-60]: the loop electrode 106 is the hot electrode for delivery of energy to the area; there is only one active electrode), and a surface area of the return electrode is greater than a surface area of the single active electrode (Batchelor [0033]: the area of the wire is smaller than the area of the grasper to concentrate current in the wire).
Regarding claim 6, the Bales/Batchelor combination discloses the tissue segmentation device of claim 1, wherein the one or more segmenting wires comprises a plurality of segmenting wires (Bales Fig. 14 shows two segmenting wires 106 and 108), the plurality of segmenting wires shaped and sized to fit within an inner diameter of the introducer tube (the wires can fit within the inner diameter of the tube as seen in Figs. 12 and 23 where the wire is smaller than the inner diameter of the tube and is being retracted within it).
Regarding claim 7, the Bales/Batchelor combination discloses the tissue segmentation device of claim 6, wherein the plurality of segmenting wires comprise an expanded position (expanded position shown in Fig. 21b) and a retracted position (retracted position shown in Fig. 21a), and wherein, when in the expanded position, the plurality of segmenting wires are configured to extend at an angle from the distal end of the introducer tube (wires extend down at an angle away from the introducer tube as seen in Fig. 21b), and when in the retracted position, the plurality of segmenting wires are parallel or substantially parallel to each other and configured to retract into the distal end of the introducer tube (the wires are parallel to each other as seen in Fig 14 and are retracted into the distal end of the introducer tube as seen in Fig. 21a).
Regarding claim 8, the Bales/Batchelor combination discloses the tissue segmentation device of claim 7, wherein, when in the expanded position, the plurality of segmenting wires are configured to segment the tissue specimen upon one of:
(1) pulling the tissue specimen into the plurality of segmenting wires using the grasper (the grasper can pull the tissue into the segmenting wires as seen in Batchelor Fig. 2), wherein the grasper comprises a return electrode (Batchelor [0033]), and wherein one or more of the plurality of segmenting wires comprise an active electrode (Bales [Col 7, lines 39-60]: the loop electrode 106 is the hot electrode for delivery of energy to the area), or
(2) moving the plurality of segmenting wires into the tissue specimen, wherein one or more of the plurality of segmenting wires comprise an active electrode (Figs. 21a-c of Bales show the active electrode 106 being forced along the tissue section to be resected).
While Bales shows a pulling mechanism rather than a pushing mechanism, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to switch the polarity of the segmenting wires 106 and 108 to allow for pushing the device over the tissue. Switching the polarities is an obvious matter of design choice since applicant has not disclosed that pushing the active electrode solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with pulling the active electrode across the target area.
Regarding claim 9, the Bales/Batchelor combination discloses the tissue segmentation device of claim 1, wherein the one or more segmenting wires comprises a plurality of segmenting wire loops (106 and 108 form loops with their respective tines as seen in Fig. 14), and wherein positioning the tissue specimen further comprises: encircling at least a portion of the tissue specimen using the plurality of segmenting wire loops (the tissue specimen is encircled by the loops as seen in Figs. 21b-c; this reading on loops is broad which is consistent with the elected species of Fig. 5 in the instant application as the loops are simply formed between the tines).
Regarding claim 10, the Bales/Batchelor combination discloses the tissue segmentation device of claim 1, further comprising: a plurality of retractable tines (tines highlighted of Bales Fig. 14 below; retractable as shown in Fig. 21a of Bales) configured to expand from and retract into the distal end of the introducer tube (tines expand and retract from the introducer tube as seen in Figs. 21a-c), wherein at least one of the plurality of retractable tines is a return electrode (the return tines highlighted below function as the return electrodes as they correspond to the cold electrode and transfer energy back to the generator Bales [Col 7, lines 39-60]) and at least two of the plurality of retractable tines are active electrodes (the active tines highlighted below function as the active electrodes as they correspond to the hot electrode and transfer energy from the generator to the tissue Bales [Col 7, lines 39-60]), wherein the return electrode is arranged opposing the active electrodes such that the return electrode does not contact the active electrodes (the active and return electrodes oppose each other as highlighted below and do not contact).
The interpretation of claim 10 is consistent with the disclosure of the instant application as it pertains to the elected species. In paragraphs [00112]-[00114], the tines are used interchangeably with the active electrode wires. There is no distinction between the segmenting wires and the tines and these paragraphs disclose that the tines and segmenting wires of the web or screen electrode are all included in the “plurality of segmenting wires” and are not a separate set of tines. This is also consistent with the 112a/b rejection as stated above. Based on the disclosure, the “tines” are simply the part of the wires that connect the wires of the web to the active and return contacts. This is disclosed by the Bales/Batchelor combination.
If it is the intent of the applicant that the tines themselves deliver the energy to the tissue, it would be of routine skill in the art to modify the insulation of Bales such that the tines expose a conductive surface to deliver or return energy. Such a modification is of routine skill in the art and would lead to the expected outcome of an increased conductive region. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to further expose the conductive surface of the tines of Bales, since applicant has not disclosed that utilizing the tines as the cutting and return surface solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the cutting surface of Bales.
[AltContent: textbox (End of)]
PNG
media_image1.png
442
494
media_image1.png
Greyscale
Response to Arguments
Applicant’s arguments, filed 10/15/2025, with respect to the specification objection have been fully considered and are persuasive in light of the amendments. The objection to the specification has been withdrawn.
Applicant’s arguments, filed 10/15/2025, with respect to the objection of claim 9 have been fully considered and are persuasive in light of the amendments. The objection claim 9 has been withdrawn.
Applicant’s arguments with respect to the 103 rejection of claim 1 have been fully considered but is not persuasive. Applicant argues that the Bales/Batchelor combination does not disclose the one or more segmenting wires extending at an angle of less than 90 degrees. However, this is not persuasive. As seen in Figs. 13 and 21b, the segmenting wires that are within the insulation 110 and 112 forming electrodes 106 and 108 extend outward and at a slight downward angle, that is less than 90 degrees, from the introducer tube. Extend is a broad term and these extend outward at an angle of less than 90 degrees, the claim does not limit the shape of the ends of the wires, only the direction in which they extend. Therefore, because the segmenting wires of Bales extend outward from the end of the introducer tube at an angle of less than 90 degrees, the limitation is disclosed by the prior art and the rejection remains.
Claims 2-3 and 5-10 remain rejected because claim 1 remains rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./ Examiner, Art Unit 3794