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Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 2, 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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bodner (US 2021/0077714) in view of Burns et al. (US 2008/0021375), and as evidenced by Nguyen et al. (US 2020/0276365).
Regarding claim 1, Bodner discloses (Figures 1A and 3) a device for electrical stimulation of a subjects brain (via piezoelectric element 142, Figure 2; ¶ [0043]); the device comprising: a case (body of port 104) comprising electronics (¶ [0044] discloses that the piezoelectric element is powered by power source 146 which is incorporated into the port 104) configured to generate electrical pulses (e.g., ¶ [0049] describes the oscillations of the piezoelectric element which are considered to meet the pulse limitation), the case including an opening (into which proximal end 128 of catheter 102 extends, Figure 2) that extends through the case (Figure 3); a probe (catheter 102 may be considered a probe as it extends into the target tissue) coupled to the case and including a lumen in communication with the opening of the case (102 extends into the body of 104 through an opening defined by catheter connector 130 as seen in Figure 3; ¶ [0040]), wherein the opening and the lumen are configured to facilitate drug delivery (through infusion port 140; ¶¶ [0040] and [0042]) to a target region in the brain (¶ [0041] discloses the target tissue as the subarachnoid space); at least one electrode (piezoelectric element 142) disposed on the probe (on the distal end of 102, Figures 2-3) and configured to deliver electrical stimulation to the target region of the brain (¶ [0048] discloses that the piezoelectric element aids in increasing the volume of dispersed medicament in the cerebrospinal fluid), wherein the electrical stimulation increases a permeability of a blood brain barrier in order to increase an effect of the drug on the target region of the brain (this is a functional limitation that the prior art device need only be capable of performing; Bodner states in ¶ [0048] that the use of the piezoelectric element increases the volume of dispersed medicament by approximately twenty times that of a catheter without a piezoelectric element; this provides the claimed result of increasing an effect of the drug on the target region of the brain; see also Nguyen et al. at ¶ [0006] which is cited here as evidence that it is known that piezoelectric elements are fully capable of aiding in the delivery of drugs across the blood-brain barrier as claimed; note that this is provided as evidence that the transducer of Bodner is fully capable of performing this claimed function even if not explicitly disclosed). Bodner does not explicitly disclose that the probe provides a lumen for receiving a drug delivery device therethrough.
Burns et al. (henceforth Burns) teaches (Figure 22) an implantable device comprising a case (body of 30, 20), a probe (cannula 95) coupled to the case (Figure 22) including a lumen (through cannula 95) in communication with an opening in the case (it extends through base opening 26 as seen in Figure 22) and comprises a lumen for receiving a drug delivery device (the upper portion of 95, as seen in Figure 10A receiving the needle IN2 of a syringe for delivering a medicament therethrough; ¶¶ [0071] and [0094] which disclose the needle inserted through the septum and into the lumen of the probe 95).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Bodner to provide the cannula in a concentric arrangement as taught by Burns so as to allow the case and cannula to be located directly over the target tissue site for treatment thereof as taught by Burns. In this manner, the catheter of Bodner would be replaced by the cannula of Burns while retaining the features of the piezoelectric element and generating components in the housing while allowing for drugs to be injected directly into the target tissue through the cannula as taught by Bodner.
Regarding claim 2, both Bodner and Burns teach that the probe is flexible (the catheter of Bodner and the cannula of Burns will have some degree of flexibility and no specific value or range of flexibility is claimed).
Regarding claim 3, Burns further teaches wherein the lumen includes a seal or diaphragm to minimize drug backflow (septum 60 is seated at the opening to the probe and will prevent backflow as claimed; Figure 22; the septum functions to allow a drug to be injected through the probe while preventing fluid from inadvertently passing into or out of the device; ¶ [0047], it is noted that this citation places the septum directly in the cannula as seen in Figure 22).
Regarding claims 4-5, Burns further teaches wherein the drug delivery device is a syringe having a needle (¶ [0075] discloses the use of a standard syringe having a needle; Figures 11J-11L depict the use of the standard syringe and needle for the injection).
Regarding claims 6-7, Burns further teaches the use of a drug delivery device as an implanted flexible tube (for these claims, the embodiment of Figure 7A may be relied upon which teaches a flexible tube (needle guard 50, even if disclosed as hard, it still comprises some level of flexibility as no values or ranges are claimed) which is implanted in the patient (it’s located within the implanted access site). The Examiner further notes that the drug delivery device of claim 1 is not positively recited. Therefore the claims which further the limit the device do not substantially limit the lumen of the probe in any meaningful way. The lumen of the probe is considered fully capable of receiving therethrough, any implanted flexible tube which might deliver a drug or therapeutic as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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, Michael Tsai can be reached at 571-270-5246. 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.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights