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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/8/2025 has been entered.
Acknowledgment
Claims 1-34, 39-41 are amended and field on 12/8/2025.
Claims 42-57 are newly added.
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 45-57 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 45 recites the limitation "wherein a radiological image is generated to determine if the trocar and the stylet are inserted at a correct trajectory, wherein the trocar and the stylet are advanced into the patient's body at the entry point based on determining that the trocar and the stylet are inserted at the correct trajectory, wherein the stylet is removed from the trocar based on advancing the trocar and the stylet into the patient's body, wherein a biopsy tool is inserted into the trocar, wherein a biopsy is performed using the biopsy tool, wherein the biopsy tool is removed from the trocar and reinserting the stylet into the trocar; and wherein the trocar and the stylet are removed from the patient's body through the stabilizer" in the last 13 lines. The claim is device/system’s claim but these are a method steps so the claim is unclear as it is not directed to the device/system. See MPEP 2173.05(p). Note: the examiner suggests to amend the claim such as "wherein the system is configured to be use with a biopsy procedure, the biopsy procedure is comprising : a radiological image is generated to determine if the trocar and the stylet are inserted at a correct trajectory, wherein the trocar and the stylet are advanced into the patient's body at the entry point based on determining that the trocar and the stylet are inserted at the correct trajectory, wherein the stylet is removed from the trocar based on advancing the trocar and the stylet into the patient's body, wherein a biopsy tool is inserted into the trocar, wherein a biopsy is performed using the biopsy tool, wherein the biopsy tool is removed from the trocar and reinserting the stylet into the trocar; and wherein the trocar and the stylet are removed from the patient's body through the stabilizer".
Claim 52 recites the limitation " wherein a radiological image is generated to determine if the trocar and the stylet are inserted at a correct trajectory, wherein the trocar and the stylet are advanced into the patient's body at the entry point based on determining that the trocar and the stylet are inserted at the correct trajectory, wherein the stylet is removed from the trocar based on advancing the trocar and the stylet into the patient's body, wherein a biopsy tool is inserted into the trocar, wherein a biopsy is performed using the biopsy tool, wherein the biopsy tool is removed from the trocar and reinserting the stylet into the trocar; and wherein the trocar and the stylet are removed from the patient's body through the stabilizer" in the last 13 lines. The claim is device/system’s claim but these are a method steps so the claim is unclear as it is not directed to the device/system. See MPEP 2173.05(p). Note: the examiner suggests to amend the claim such as "wherein the device is configured to be use with a biopsy procedure, the biopsy procedure is comprising : a radiological image is generated to determine if the trocar and the stylet are inserted at a correct trajectory, wherein the trocar and the stylet are advanced into the patient's body at the entry point based on determining that the trocar and the stylet are inserted at the correct trajectory, wherein the stylet is removed from the trocar based on advancing the trocar and the stylet into the patient's body, wherein a biopsy tool is inserted into the trocar, wherein a biopsy is performed using the biopsy tool, wherein the biopsy tool is removed from the trocar and reinserting the stylet into the trocar; and wherein the trocar and the stylet are removed from the patient's body through the stabilizer".
Allowable Subject Matter
Claims 45, 52 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 35-38, 42-44 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claim 35, a method, comprising: placing a stabilizer over an entry point in a patient's body; inserting a trocar and a stylet into the stabilizer, wherein the stabilizer comprises: a main portion through which the trocar and the stylet is inserted; and a plurality of stabilizing portions of the stabilizer, wherein the plurality of stabilizing portions are configured to be removable from the main portion based on at least one of perforated sections or lines between the main portion and the plurality of stabilizing portions, and advancing the trocar and the stylet into the patient's body at the entry point based on determining that the trocar and the stylet are inserted at the correct trajectory; removing the stylet from the trocar based on advancing the trocar and the stylet into the patient's body; inserting a biopsy tool into the trocar; performing a biopsy using the biopsy tool; removing the biopsy tool from the trocar and reinserting the stylet into the trocar; and removing the trocar and the stylet from the patient's body through the stabilizer in combination with other claimed structure was not found or rendered obvious by the prior art of record..
In particular, Gross in view of Chesbrough is the closest prior art of record. Even though Gross in view of Chesbrough a method, comprising: placing a stabilizer over an entry point in a patient's body; inserting a trocar and a stylet into the stabilizer, wherein the stabilizer comprises: a main portion through which the trocar and the stylet is inserted; and a plurality of stabilizing portions of the stabilizer, wherein the plurality of stabilizing portions are configured to be removable from the main portion based on at least one of perforated sections or lines between the main portion and the plurality of stabilizing portions, but it fails to disclose advancing the trocar and the stylet into the patient's body at the entry point based on determining that the trocar and the stylet are inserted at the correct trajectory; removing the stylet from the trocar based on advancing the trocar and the stylet into the patient's body; inserting a biopsy tool into the trocar; performing a biopsy using the biopsy tool; removing the biopsy tool from the trocar and reinserting the stylet into the trocar; and removing the trocar and the stylet from the patient's body through the stabilizer.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments filed on 12/8/2025 with respect to claim(s) 45, 52 have been considered and persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783