Prosecution Insights
Last updated: August 08, 2026
Application No. 17/631,251

INTRACRANIAL DELIVERY OF MEDICINAL SOLUTION

Non-Final OA §103
Filed
Jan 28, 2022
Priority
Aug 01, 2019 — provisional 62/881,875 +2 more
Examiner
PAZ ESTEVEZ, GUILLERMO G
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Theracle, Inc.
OA Round
3 (Non-Final)
17%
Grant Probability
At Risk
3-4
OA Rounds
0m
Est. Remaining
29%
With Interview

Examiner Intelligence

Grants only 17% of cases
17%
Career Allowance Rate
2 granted / 12 resolved
-53.3% vs TC avg
Moderate +12% lift
Without
With
+12.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
26 currently pending
Career history
70
Total Applications
across all art units

Statute-Specific Performance

§103
60.1%
+20.1% vs TC avg
§102
25.7%
-14.3% vs TC avg
§112
12.3%
-27.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 12 resolved cases

Office Action

§103
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/17/2026 has been entered. 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. Claims 1-3, 12, 22, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1). Regarding claim 1, discloses a system (infusion system 100, Fig 1; Fig 10) for delivery of a solution (therapeutic agent; [0088]) to a brain (target tissue location 119, Fig 2-3) in a brain of a subject (brain 116, Fig 2-3), the system comprising: a catheter (catheter 102, Fig 10; [0108]) having a proximal end (1000, Annotated Fig 1; [0084]) and a distal end (1001, Annotated Fig 1), the catheter (102) defining at least one catheter lumen (Fig 10, [100]: “lumens of, respectively, the therapy catheter 102 and the delivery catheter 104”); a cranial burr hole stopple (burr hole anchor 200, Fig 4 and 10), the stopple (200) defining a stopple opening (bore 318, Fig 10) structured for advancement of the catheter (102) therethrough (Fig 10); the stopple (200) comprising: a plug (spherical member 314, Fig 10) structured to be inserted into a burr hole (burr hole 110, Fig 5) in a cranium of the subject (skull 111, Fig 10), the plug (314) comprising at least one seal (350; Fig 10) positioned on a wall (contact area 324, Fig 10) of the stopple opening (318) to form a fluidic seal ([0110]: “sleeve 350 that defines a contact area 324 between the spherical member and the medical device (e.g., catheter 102) to frictionally engage the medical device”; sleeve 350 can be made of silicone [0012] and surrounds the catheter having a frictionally engagement forming the seal) with an exterior of the catheter (exterior surface of the catheter 102, Fig 10; [0110]); a flange (base 202, Fig 10 ) structured to engage an outer surface of a skull of the subject when the plug (314) is inserted into the burr hole (110) (Fig 10; [0093]); a first groove (groove 220, Fig 10) on a top portion of the flange (202); and a connecting member (connector 204, Fig 6 and 10) having a proximal end (second end 228, Fig 6) and a distal end (first end 226, Fig 6), the distal end (226) structured to be coupled to the proximal end of the catheter (1000, Annotated Fig 1), the connecting member (204) defining at least one connecting member lumen (Fig 6-7; [0100]: “The connector 204 is hollow to permit passage of fluid from the delivery catheter 104 to the therapy catheter 102”); and a connector tube (delivery catheter 104, Fig 10) having a proximal end (105, Fig 1) and a distal end (114, Fig 1), the distal end (114) structured to be coupled to the connecting member (204) proximal end (228), the connector tube (104) defining at least one connector tube lumen (Fig 10; [100], [136]); wherein the at least one catheter lumen (lumen of 102, Fig 10), the at least one connecting member lumen (lumen of 204, Fig 10), and the at least one connector tube lumen (lumen of 104, Fig 10) are structured to provide at least one flow path (Flow path from 104 to 204 to 102; [100]), when assembled together, for delivery of the solution (therapeutic agent; [0088]) to the brain (116) PNG media_image1.png 775 999 media_image1.png Greyscale Nelson is silent wherein the first groove is structured to directly engage and fix the catheter in a first position on the flange; wherein a second groove on the top portion of the flange and wherein the second groove is structured to directly engage and fix the catheter in a second position on the flange. Paspa teaches a system (burr hole cover 100, Fig 1; Fig 4) comprising a first groove (first groove 132, Fig 1) wherein the first groove (first groove 132) is structured to directly engage and fix the catheter (catheter 203, Fig 4B; [0079]) in a first position (position defined by first groove 132; Fig 1) on the flange (retainer 110, Fig 4); and a second groove (second groove 132, Fig 1) wherein the second groove (second groove 132) on the top portion of the flange (first and second grooves 132 extends from the top portion of the flange 110, Fig 1 and 4A) and wherein the second groove (second groove 132) is structured to directly engage and fix the catheter (catheter 203, Fig 4B; [0079]) in a second position (position of second groove 132, which differ from the first groove 132) on the flange (110) ([0079], Fig 4A). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Nelson with similar interference between the groove and the catheter and incorporate a second groove as taught by Paspa for the purpose of resist forces that otherwise might cause the catheter to pop out or otherwise come loose of the groove and provide options by having multiple securing positions ([0071]). Regarding claim 2, Nelson/Paspa discloses the system of claim 1. Nelson disloses further comprising: a pump (106, Fig 1) having an outlet (1005, Annotated Fig 2) structured to be coupled to the proximal end (105) of the connector tube (104), the pump (106) structured to pump the solution (therapeutic agent; [0088]) through the flow path (Flow from 104 to 204 to 102); and a reservoir for storage of the solution, the reservoir fluidically coupled to the pump ([0086]). PNG media_image2.png 777 626 media_image2.png Greyscale Regarding claim 3, Nelson/Paspa discloses the system of claim 1. Nelson discloses wherein the at least one catheter lumen (Lumen of catheter 102) is sized and structured for advancement of a positioning stylette therethrough ([0133]: “When the medical device has been positioned, the guide cannula 124 may be withdrawn or retracted (moved in the direction 130) as shown in FIG. 23 while holding the device 102 in place, e.g., with a stylet (not shown) and the stereotactic apparatus 103 (see FIG. 1)”). Regarding claim 12, Nelson discloses a method for the intracranial delivery of an active agent ([0088]: “chemotherapeutic agents”) to a brain of a subject (Fig 1;[0088]), the method comprising: positioning a burr hole stopple in a burr hole (110, Fig 10 ) in a cranium (skull 111, Fig 10) of the subject ([0008]; Fig 4 show the position of burr hole anchor 200), the burr hole stopple (burr hole anchor 200, Fig 4 and 10) comprising: a flange (annular base 202, Fig 10) structured to engage an outer surface of the cranium (111) when the burr hole stopple (200) is positioned in the burr hole (110), a first groove (groove 220, Fig 1) on a top surface of the flange (202) (Fig 7 shows groove 220 on a top surface of flange 202 of burr hole anchor 200) at a first location on the top surface of the flange (location of groove 220 on the flange 202; Fig 4); advancing a catheter (catheter 102, Fig 10; [0108]) through a sealable opening (bore 318, Fig 10; ([0110]: “sleeve 350 that defines a contact area 324 between the spherical member and the medical device (e.g., catheter 102) to frictionally engage the medical device”; sleeve 350 can be made of silicone [0012] and surrounds the catheter having a frictionally engagement forming the seal)) in the burr hole stopple (burr hole anchor 200, Fig 4 and 10) such that a distal tip of the catheter (tip 108 of catheter 102, Fig 10) is positioned at a site (target tissue location 119, Fig 1) in the brain, the catheter defining a fluidic lumen (lumen of 102, Fig 10), the catheter (102) further defining at least one aperture (aperture of distal tip 108, Fig 10) fluidically coupled to the fluidic lumen (lumen of 102, Fig 10) at a distal portion (1000, Annotated Fig 1) of the catheter (102); creating a flow path (Flow path from 104 to 204 to 102; [100]) between the site (119) and a pump (pump 106, Fig 1) operatively coupled to a reservoir (reservoir, [0086]) containing a solution (therapeutic agent ;[0088]) comprising the active agent (chemotherapeutic agents; [0088]); wherein creating the flow path comprises: coupling a proximal end of the catheter (102) to a distal end of a connecting member (204) (Fig 10), the connecting member (204) defining at least one connecting member lumen (lumen of connector 204, Fig 10), coupling a distal end of a connector tube (104) to a proximal end of the connecting member (204) (Fig 10), the connector tube (104) defining at least one connector tube lumen (lumen of delivery catheter 104, Fig 10), and coupling a proximal end of the connector tube (proximal end of 104, Fig 10) to the pump (106) or to the reservoir (reservoir, [0086]); and pumping the solution ([0088]) from the reservoir ([0086])to the site (119) via the flow path (Flow path from 104 to 204 to 102). Nelson is silent regarding a second groove on the top surface of the flange at a second location on the top surface of the flange; affixing a proximal portion of the catheter in the first groove by direct engagement of the catheter with the first groove; affixing the proximal portion of the catheter in the second groove by direct engagement of the catheter with the second groove. Paspa teaches a method comprising a second groove (second groove 132, Fig 1) on the top surface of the flange at a second location on the top surface of the flange (second groove 132 is located and extends from a top surface of the flange 110, Fig 4 at a second location; note the first location is defined by the location of the first groove 132 on the top of the flange 110; Fig 1 and 4A); affixing a proximal portion of the catheter (proximal portion of catheter 203, extending from burr hole) in the first groove (first groove 132, Fig 1; [0079]) by direct engagement of the catheter (203) with the first groove (first groove 132, Fig 1); affixing the proximal portion of the catheter (proximal portion of catheter 203, extending from burr hole and inserted in first groove [0079]) in the second groove (second groove 132, Fig 1) by direct engagement of the catheter (203) with the second groove (second groove 132, Fig 1) ([0079] shows that the catheter can engage with the grooves 132). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Nelson with similar interference between the groove and the catheter and incorporate a second groove as taught by Paspa for the purpose of resist forces that otherwise might cause the catheter to pop out or otherwise come loose of the groove and provide options by having multiple securing positions ([0071]). Regarding claim 22, Nelson/Paspa discloses the system of claim 1. Nelson discloses wherein the plug (314) is sized to extend through the burr hole (110) past the cranium (111) (Fig 10, plug (314) is partially between the whole and partially outside the skull). Regarding claim 25, Nelson/Paspa discloses the system of claim 1. Nelson is silent wherein an axis of the first groove is different than an axis of the second groove. Paspa teaches wherein an axis of the first groove (first groove 132, Fig 1) is different than an axis of the second groove (second groove 132, Fig 1) (Fig 1 shows first, second and third grooves 132 spaced apart around the flange 110; the longitudinal axis of the first groove 132 and the longitudinal axis of the second groove are different). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Nelson with similar relative position between first and second groove as taught by Paspa for the purpose of provide options by having multiple securing positions ([0071]). Regarding claim 26, Nelson/Paspa discloses the system of claim 1. Nelson is silent wherein an opening at a top of the first groove is smaller than an outer diameter of the catheter and an opening at a top of the second groove is smaller than the outer diameter of the catheter. Paspa teaches an opening at a top of the first groove ( width 415 of opening at the top of the first groove 132) is smaller than an outer diameter of the catheter (diameter 420 of the catheter 203, Fig 4A-B) and an opening at a top of the second groove (second groove 132; [0071]) is smaller than the outer diameter of the catheter ([0071]; all grooves 132 are structurally the same but located at different positions). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Nelson with similar interference between the groove and the catheter and incorporate a second groove as taught by Paspa for the purpose of resist forces that otherwise might cause the catheter to pop out or otherwise come loose of the groove and provide options by having multiple securing positions ([0071]). Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable by Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in further view of Wentling et al. (US 20040193098 A1). Regarding claim 5, Nelson/Paspa discloses the system of claim 1. Nelson is silent regarding wherein the catheter has a durometer in a range of 20-40. Wentling teaches a catheter (catheter 10, Fig 12A-B) including a diffuser (diffuser 242, Fig 12A-B; [0008]) wherein the catheter has a durometer in a range of 20-40 ([0091]: “The diffuser 242 is preferably constructed from silicone having a durometer of 30A on the Shore Durometer scale”). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the distal end of the catheter disclosed by Nelson/Paspa to include a similar diffuser as the one taught by Wentling having a Durometer of 30A, the diffuser can have a cylindrical shape as the one shown in Fig 1A of Wentling to enable gentle interaction and diffusion of medicament with the target structure ([0063]). Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in view of Harris (US 3985140 A). Regarding claim 6, Nelson/Paspa discloses the system of claim 1. Nelson is silent regarding the system further comprising a one-way valve to prevent backflow of fluids from the brain into the flow path. Harris teaches a system (ventricular shunt system [abstract], Fig 1]) comprising a catheter (catheter 10, Fig 1) further comprising a one-way valve (one-way valve 24, Fig 2) to prevent backflow of fluids (CSF) from the brain into the flow path (Col 4. Lines 37-40 : “The valve 24 both acts as a check valve to prevent backflow of CSF fluid, and maintains a threshold operating pressure dictated by the force exerted by spring 44 on ball 46.”). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the system of Nelson/Paspa to include a similar one-way valve as the one taught by Harris, near the proximal end of the catheter 102 to prevent backflow of CSF into the flow path (Col 4. Lines 37-40 : “The valve 24 both acts as a check valve to prevent backflow of CSF fluid, and maintains a threshold operating pressure dictated by the force exerted by spring 44 on ball 46.”). Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in view of Parker (US 5221270 A). Regarding claim 8, Nelson/Paspa discloses the system of claim 1. Nelson discloses wherein the catheter (102) comprises a distal portion (1000, Annotated Fig 1). However, Nelson is silent regarding a distal portion having a first durometer and a remainder portion having a second durometer greater than the first durometer. Parker teaches a catheter (catheter 10, Fig 1) comprising a distal portion(soft tubular tip 12, Fig 1) having a first durometer (Col 3, lines 15-23: “The soft tip preferably comprises a soft durometer polyether block amide material such as nylon with a durometer of approximately 75 on the Shore A scale”) and a remainder portion having a second durometer (claim 10) greater than the first durometer. (Claim 11)(The tip durometer is softer (lower D value) than the durometer of the remainder portion of the outer layer (higher D value compared to the tip on the Shore D scale)). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the catheter 102 of Nelson/Paspa to have a softer distal end 1000 of lower durometer than the remainder portion of the shaft 102 as taught by Parker for atraumatic insertion in the target area (Col 3 line 55-59). Claims 9 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in view of Radojicic (US 20120271168 A1). Regarding claim 9, Nelson/Paspa discloses the system of claim 1. Nelson is silent regarding the system further comprising a pressure sensor structured to provide information on a flow rate of medicinal solution through the flow path. Radojicic teaches a catheter (computational catheter medical device, Fig 1) comprising a pressure sensor (sensory arrays 104, Fig 1; [0042]-[0043]: “Flow sensors may include any of differential pressure(…)”) structured to provide information on a flow rate of solution through the flow path (108) ([0043]-[0044]) Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the device of Nelson/Paspa to include a similar sensor array including a differential pressure sensor to measure flow rate of the medication being introduced into the target area ([0043-0044]). Claim 13 rejected under 35 U.S.C. 103 as being unpatentable by Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in view of Lieberman (US 20050043673 A1). Regarding claim 13, Nelson/Paspa discloses the method of claim 12. Nelson discloses where advancing the catheter comprises: advancing a stylette (stylet; [0133]) through the burr hole stopple opening (318) to the site (119) in the brain ([0133]). Nelson is silent regarding advancing the catheter over the stylette such that a tip of the catheter is positioned at or in the site; and removing the stylette. Lieberman teaches a method (Fig 7A-B; [0037]) comprising advancing a catheter (catheter 310, Fig 7A-B) over a stylette (stylette 209, Fig 7A-B)such that a tip of the catheter tip of catheter 310Fig 7A-B) is positioned at or in the tissue site (subdural hematoma 150, Fig 7A-B); and removing the stylette (209)([0037]). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the method of Nelson/Paspa to guide the catheter using a similar stylette as the one taught by Lieberman for accurate placement of the catheter in the target tissue ([0037]). Claims 14-18, and 27 are rejected under 35 U.S.C. 103 as being unpatentable by Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in further view of Gill et al. (US 20150037437 A1). Regarding claim 14, Nelson/Paspa discloses the method of claim 12. Nelson discloses wherein the solution (therapeutic agent; [0088]) is delivered to the site (119). Nelson is silent regarding the delivery being in a regimen comprising at least one on period and at least one off period. Gill teaches a method to treat a growth (glioma; [0015], [0034]) the delivery being in a regimen comprising at least one on period and at least one off period ([0017]-[0020]: duration of infusion and schedule regimen having on and off periods). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the infusion schedule of Nelson/Paspa with the teaching of Gill of alternating infusion regimen of the chemotherapy agent for optimal treatment of Glioma (abstract). Regarding claim 27, Nelson/Paspa discloses the method of claim 12. Nelson is silent regarding wherein a flow rate and a duration of delivery of the solution are selected based on an established model so as to achieve a selected steady state diffusion volume of solution in the site in the brain. Gill teaches a method to treat a growth (glioma; [0015], [0034]) wherein a flow rate ([0021]; Claim 18) and a duration of delivery ([0020]; claim 16) are selected based on an established model ([0058];models from animals and previous patient) so as to achieve a selected steady state diffusion volume ([0127]-[0128]) of medicinal solution in the brain tissue (chemotherapy agent, claim 25). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Nelson/Paspa with a similar model as taught by Gill to dispense a chemotherapy agent at recommended flowrate and period of time for optimal treatment of Glioma (abstract). Regarding claim 15, Nelson/Paspa/Gill discloses the method of claim 27. Nelson is silent regarding wherein the model is established based on brain imaging observations of diffusion volume using infusion of contrast agents at various flow rates over time. Gill teaches a method to treat a growth (glioma; [0015], [0034]) wherein the model is established based on brain imaging observations ([0010];[0128];[0046]) of diffusion volume using infusion of contrast agents (gadolinium-DTPA) at various flow rates over time ([0010];[0128];[0046]). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Nelson/Paspa/Gill different diffusion volumes using contrast agents as taught by Gill for the purpose of imaging the chemotherapy agent distribution clinically ([0010]) and to visualize distribution of the infusion to ensure that adequate drug distribution is achieved through the intended target volume ([0128]). Regarding claim 16, Nelson/Paspa/Gill the method of claim 27. Nelson discloses wherein the site (119) is within or in proximity to a growth ([0088]: discloses that therapeutic agents include chemotherapeutic agents; [0082]: “therapy delivery tip or end 108 is located at a target tissue location 119 in the brain.”; therefore target site in case of chemotherapeutic agents is a growth located in the brain at or near target site 119). Nelson is silent regarding the selected steady state diffusion volume is larger than a volume of the growth to treat a selected healthy tissue margin surrounding the growth. Gill teaches a method to treat a growth (glioma; [0015], [0034]) wherein the selected steady state diffusion volume is larger than a volume of the growth to treat a selected healthy tissue margin surrounding the growth. [0025]: “In an embodiment of the invention the chemotherapy agent may delivered into a tumour and its penumbra. Generally the penumbra incorporates a margin of at least 20 mm around the tumour as visualised by Magnetic Resonance Imaging (MRI).”) ([0027]) Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the method disclosed by Nelson/Paspa/Gill to have a steady state diffusion of the chemotherapy agent delivered to the tumor and its penumbra as taught by Gill to increase the efficacy of the treatment decreasing the chance of recurrence of the tumor or metastasis of cancer cells that are not visible ([0025]; [0027]). Regarding claim 17, Nelson/Paspa/Gill the method of claim 16. Nelson is silent wherein the active agent comprises a chemotherapeutic agent having an active form and an inactive form and wherein the chemotherapeutic agent remains in the active form in cancerous brain tissue and converts to the inactive form in healthy brain tissue. Gill teaches a method to treat a growth (glioma; [0015], [0034]) wherein the active agent (chemotherapy agent) comprises a chemotherapeutic agent (topotecan; [0034]) having an active form (lactone form) and an inactive form (open ring inactive carboxylate form)and wherein the chemotherapeutic agent (topotecan) remains in the active form (lactone form) in cancerous brain tissue and converts to the inactive form (open ring inactive carboxylate form) in healthy brain tissue (Topotecan has an inherent active and inactive configuration based on ph, therefore it change from its active to inactive based on the ph of the brain portion.) Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to implement topotecan as the chemotherapy agent of Nelson/Paspa/Gill as taught by Gill. Topotecan is well known in the art and is provided by Gill as a chemotherapy agent to treat brain tumors ([0015; 0034] ; Claim 25) Regarding claim 18, Nelson/Paspa/Gill the method of claim 17. Nelson is silent wherein the chemotherapeutic agent comprises topotecan. Gill teaches a method to treat a growth (glioma; [0015], [0034]) wherein the chemotherapeutic agent comprises topotecan. (topotecan; [0034]) Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to implement topotecan as the chemotherapy agent of Nelson/Paspa/Gill as taught by Gill. Topotecan is well known in the art and is provided by Gill as a chemotherapy agent to treat brain tumors ([0015; 0034] ; Claim 25) Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 20140276416 A1) in view of Paspa et al. (US 20130304216 A1) in view of Stratton et al. (US 20100312193 A1). Regarding claim 23, Nelson/Paspa discloses the system of claim 1 wherein the seal (350). Nelson is silent wherein the seal comprises a septum seal. Stratton teaches a system (Fig 10) comprising a septum seal (claim 3). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the seal cap of device of Nelson/Paspa with similar septum seal as taught by Stratton for the purpose of allowing insertion of a medical device and maintain a sealed passageway (claim 1; [0040]) Response to Arguments Applicant’s arguments with respect to claims 1-3, 5-6, 8-9, 12-18, 22-23, and 25-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00. 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, Kevin Sirmons can be reached on (571) 272-4965. 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. /GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783 /Lauren P Farrar/Primary Examiner, Art Unit 3783
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Prosecution Timeline

Show 3 earlier events
Jun 25, 2025
Response Filed
Oct 20, 2025
Final Rejection mailed — §103
Jan 15, 2026
Applicant Interview (Telephonic)
Jan 20, 2026
Response after Non-Final Action
Jan 23, 2026
Examiner Interview Summary
Feb 17, 2026
Request for Continued Examination
Mar 09, 2026
Response after Non-Final Action
Apr 07, 2026
Non-Final Rejection mailed — §103 (current)

Precedent Cases

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Patent 12403264
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3y 12m to grant Granted Sep 02, 2025
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Prosecution Projections

3-4
Expected OA Rounds
17%
Grant Probability
29%
With Interview (+12.5%)
3y 10m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 12 resolved cases by this examiner. Grant probability derived from career allowance rate.

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