Prosecution Insights
Last updated: April 19, 2026
Application No. 18/218,427

IMPLANTABLE DRUG DELIVERY SYSTEMS, ASSEMBLIES, AND METHODS

Non-Final OA §102
Filed
Jul 05, 2023
Examiner
RODRIGUEZ, CRIS LOIREN
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Theracle, Inc.
OA Round
1 (Non-Final)
15%
Grant Probability
At Risk
1-2
OA Rounds
3y 4m
To Grant
26%
With Interview

Examiner Intelligence

Grants only 15% of cases
15%
Career Allow Rate
27 granted / 175 resolved
-54.6% vs TC avg
Moderate +10% lift
Without
With
+10.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
41 currently pending
Career history
216
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
45.4%
+5.4% vs TC avg
§102
28.8%
-11.2% vs TC avg
§112
22.3%
-17.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 175 resolved cases

Office Action

§102
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 . Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-2, 12-13, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al (US 20110270187 A1), as evidence by Nelson (US 5702372 A). Regarding claim 1, Nelson (‘187) discloses a connection assembly 201 for an implantable drug delivery system (fig 1), the connection assembly comprising: a base member 202 configured to be attached to a skull of a recipient, the base member comprising: an access hole 208 for accessing a burr hole 110 in the skull of the recipient; and an outer guide channel 214 that extends along an outside edge of the base member; and a manifold 204 configured to fluidically couple a proximal end portion of a microcatheter 102 to a distal end portion of a source catheter 104 (fig 2); wherein the base member 202 is configured to position the microcatheter through the access hole (figure 2 at 113) and in the outer guide channel when a distal end portion of the microcatheter 102 is implanted in a brain 116 of the recipient. Regarding claim 2, Nelson (‘187) discloses the manifold 204 is integrally formed with the base member. This claim is considered a product-by-process claim. Therefore, the final product will be given patentable weight. [See 0044]. Regarding claim 12, Nelson (‘187) discloses further comprising a cover 203 configured to cover the base member and the manifold. Regarding claims 13 and 17, Nelson (‘187) discloses a drug delivery system implantable in a recipient and method, comprising: a cranial port 201 and attaching it to a skull (figs 1 and 7; 0037]) comprising: a base member 202 configured to be attached to a skull of the recipient and comprising: an access hole 208 for accessing a burr hole 110 in the skull of the recipient; and an outer guide channel 214 that extends along an outside edge of the base member; and a manifold 204; and a microcatheter 102 comprising: a proximal end portion 113 (fig 2) configured to be fluidically connected to the manifold 204 (figures 1- 2); and a distal end portion 108 configured to be implanted (then implanted, [0037],) at a target location within the recipient and comprising an elution opening configured to elute a fluid to the target location. (Nelson (‘187) discloses that infusion therapy will be delivered into target area 116. Nelson (‘372) shows as evidence that an infusion catheter having elution openings 16 in figure 1 to deliver treatment to a brain as well known in the art); wherein the base member 202 is configured to position the microcatheter through the access hole (figure 2 at 113) and in the outer guide channel when the distal end portion of the microcatheter is implanted at the target location. Regarding claim 18, Nelson (‘187) further discloses a source catheter 104 comprising: a proximal end portion configured to be fluidically connected to a fluid source 106 configured to provide a fluid (fig 1); and a distal end portion 114 configured to be fluidically connected to the manifold 204. Regarding claim 19, Nelson (‘187) discloses the manifold 204 is integrally formed with the base member. This claim is considered a product-by-process claim. Therefore, the final product will be given patentable weight. Nelson discloses this limitation in [0044]. Allowable Subject Matter Claims 3- 11, 14-16, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm.. 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, 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. 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. /Cris L. Rodriguez/ Primary Patent Examiner Art Unit 3783
Read full office action

Prosecution Timeline

Jul 05, 2023
Application Filed
Mar 06, 2026
Non-Final Rejection — §102 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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Patent 12576207
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Patent 12569621
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2y 5m to grant Granted Feb 24, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
15%
Grant Probability
26%
With Interview (+10.5%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 175 resolved cases by this examiner. Grant probability derived from career allow rate.

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