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 .
Response to Amendment
The Amendment filed on 12/29/2025 has been entered. Claims 1-4, 6-13, 15-19, and 22 remain pending in the application. Claims 24-27 are new. Claims 2, 7, 13, 15-19 and 22 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 10/10/2023.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 7/23/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/16/2025 and 12/29/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1, 3-4, 6, 8-12, and 24-27 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.
In regard to claim 1,
Line 2 recites “an aspiration lumen aspirating brain fluid”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). As currently claimed, the method step of “aspirating brain fluid” is improper as the claim is drawn to a device, not a method. For examination purposes Examiner construes “an aspiration lumen aspirating brain fluid” to be “an aspiration lumen for aspirating brain fluid”. Examiner suggests replacing “an aspiration lumen aspirating brain fluid” in line 2 of claim 1 with “an aspiration lumen for aspirating brain fluid”.
Line 2-3 recites “an infusion lumen infusing a drug”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). As currently claimed, the method step of “infusing a drug” is improper as the claim is drawn to a device, not a method. For examination purposes Examiner construes “an infusion lumen infusing a drug” to be “an infusion lumen for infusing a drug”. Examiner suggests replacing “an infusion lumen infusing a drug” in line 2-3 of claim 1 with “an infusion lumen for infusing a drug”.
Examiner notes claims 3-4, 6, 8-12, and 24-27 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 4,
Line 4 recites “the distal end of the infusion lumen”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if “the distal end of the infusion lumen” is intended to refer to “a distal end of the infusion lumen” or to the distal end of the catheter. For examination purposes Examiner construes “the distal end of the infusion lumen” to be “a distal end of the infusion lumen”. Examiner suggests replacing “the distal end of the infusion lumen” in line 4 of claim 1 with “a distal end of the infusion lumen”.
In regard to claim 27,
Line 1-2 recites “wherein the plurality of slits opens when the drug is infused and closes when the drug is not infused”. Claim 27 depends on claim 1. Claim 1 positively requires the drug to be infused. Claim 27 appears to claim 1 method step due to the positive terms “opens” and “closes”. For examination purposes Examiner construes “wherein the plurality of slits opens when the drug is infused and closes when the drug is not infused” to be “wherein the plurality of slits is configured to open when the drug is infused and close when the drug is not infused”. Examiner suggests replacing “wherein the plurality of slits opens when the drug is infused and closes when the drug is not infused” in line 1-2 of claim 27 with “wherein the plurality of slits is configured to open when the drug is infused and close when the drug is not infused”.
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.
Claims 1, 3-4, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over a first embodiment of Geiger (U.S. PG publication 20090131857) further in view of Mahurkar (U.S. Patent no 4583968) as evidenced by Mahurkar (U.S. patent no 5197951) further in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) further in view of a second embodiment of Geiger (U.S. PG publication 20090131857). For clarity purposes Mahurkar (U.S. patent no 5197951) will be referred to as Mahurkar951.
In regard to claim 1,
A first embodiment of Geiger discloses an intraventricular access device (see figure 2, item 204 and 202), comprising:
a catheter (figure 2, item 202) including an aspiration lumen (lumen used to remove cerebrospinal fluid; paragraph [0016] and [0018]) aspirating a brain fluid (cerebrospinal fluid; paragraph [0016] and [0018]) and an infusion lumen (lumen used to infuse drug paragraph [0016]-[0017]) infusing a drug (drug; paragraph [0016]-[0017];), wherein a distal end of the catheter is configured to be positionable, during use, in a subject's brain (see figure 2; paragraph [0016]); wherein a distal end of the aspiration lumen comprises a first opening (opening of aspiration lumen which is used to remove cerebrospinal fluid from the brain; see figure 2 of Geiger; paragraph [0016] and [0018] of Geiger) and the infusion lumen comprises an opening (opening of infusion lumen which is used to deliver a drug to the brain; see figure 2 of Geiger; paragraph [0016]-[0017] of Geiger); and
a container (figure 2, item 204) forming a reservoir (chamber of container connected to the aspiration lumen which receives fluid from the aspiration lumen; see figure 2; paragraph [0016] and [0018]) and coupled to a proximal end of the aspiration lumen (see figure 2; paragraph [0016] and [0018]), wherein the proximal end of the aspiration lumen is in fluid communication with the reservoir (see figure 2; paragraph [0016] and [0018]);
the infusion lumen configured such that the infusion lumen is not in fluid communication with the sampling reservoir (paragraph [0016]-[0017]; Examiner notes the infusion lumen is in communication with the other chamber of the container).
A first embodiment of Geiger is silent that the reservoir is specifically for sampling and fails to disclose the infusion lumen comprises a plurality of second openings and wherein the first opening and the plurality of second opening are directed in substantially opposing directions to inhibit cross contamination of the brain fluid and the drug; wherein a proximal end of the infusion lumen is coupled, during use, to an external pump or an implantable pump, the infusion lumen configured such that the external pump or the implantable pump is not in fluid communication with the sampling reservoir. As a result, the first embodiment of Geiger is silent as to a container forming a sampling reservoir and wherein the proximal end of the aspiration lumen is in fluid communication with the sampling reservoir.
Examiner notes paragraph [0068] of Applicant’s disclosure defines substantially opposing directions as at least orthogonally relative to one another.
[AltContent: textbox (Distal end of aspiration lumen)][AltContent: ][AltContent: textbox (Distal end of infusion lumen)][AltContent: ]
PNG
media_image1.png
325
97
media_image1.png
Greyscale
Mahurkar teaches an aspiration lumen (figure 7, item 14) aspirating a first fluid (column 4, line 38-46) and an infusion lumen (figure 7, item 13) infusing a second fluid (column 4, line 38-46), wherein a distal end of the aspiration lumen (see figure 7 above) comprises a first opening (figure 7, item 19) and a distal end of the infusion lumen (see figure 7 above) comprises a plurality of second openings (figure 7, item 21 and 18), and wherein the first opening and the plurality of second openings are directed in substantially opposing directions to inhibit cross contamination of the first fluid and the second fluid (see figure 7; as noted above, paragraph [0068] of Applicant’s disclosure defines substantially opposing directions as at least orthogonally relative to one another. Examiner notes due to the placement of each opening, cross contamination would be inhibited; column 3, line 65-column 4, line 14. Examiner notes “to inhibit cross contamination” is a functional limitation. The first opening and the plurality of second openings are fully capable of the recited function due to their structure and arrangement).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first opening of Geiger, which is used to aspirate a brain fluid, to be a side opening, and to modify the second opening of Geiger, which is used to infuse a drug, to be a plurality of openings directed in a substantially opposing direction of the first opening, and to modify the placement of the first opening and the plurality of openings second openings to be axially displaced from one another, as taught by Mahurkar, therefore resulting in the infusion lumen comprises a plurality of second openings and wherein the first opening and the plurality of second opening are directed in substantially opposing directions to inhibit cross contamination of the brain fluid and the drug (as the device of Geiger aspirates brain fluid and infuses a drug) for the purpose of ensuring flow is not impeded (column 3, line 65-column 4, line 14 of Mahurkar) and for the purpose of ensuring there is axial as well as circumferential separation of the openings for fluid circulation (column 3, line 65-column 4, line 14 of Mahurkar) and further as evidenced by Mahurkar951 which supports an axial separation of openings prevents unwanted mixing (column 3, line 39-50 of Mahurkar951).
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 is silent as to the reservoir is specifically for sampling and fails to disclose wherein a proximal end of the infusion lumen is coupled, during use, to an external pump or an implantable pump, the infusion lumen configured such that the external pump or the implantable pump is not in fluid communication with the sampling reservoir. As a result, the first embodiment of Geiger is silent as to a container forming a sampling reservoir and wherein the proximal end of the aspiration lumen is in fluid communication with the sampling reservoir.
John teaches a container (figure 1A, item 130) forming a sampling reservoir (paragraph [0026]) and wherein the proximal end of the aspiration lumen (item 120) is in fluid communication with the sampling reservoir (paragraph [0026]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the container to enable sampling from the reservoir of the container coupled to the aspiration lumen of Geiger in view of Mahurkar as evidenced by Mahurkar951, as taught by John, for the purpose of enabling sampling and testing of CSF (paragraph [0026]-[0027] of John) while preventing leakage during sampling (paragraph [0026] of John) and further as evidenced by Delgado which supports that withdrawing a fluid from a reservoir of a container (item 24 of Delgado) implanted beneath the scalp (similar location to the container of Geiger) using a needle is possible (see figure 1 and column 2, line 44-52 of Delgado and column 3, line 3-11 of Delgado). Examiner notes the modification of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado would result in the reservoir of Geiger being a sampling reservoir and wherein the proximal end of the aspiration lumen is in fluid communication with the sampling reservoir.
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado fails to disclose wherein a proximal end of the infusion lumen is coupled, during use, to an external pump or an implantable pump, the infusion lumen configured such that the external pump or the implantable pump is not in fluid communication with the sampling reservoir.
A second embodiment of Geiger teaches wherein a proximal end of the infusion lumen (figure 3, item 302) is coupled, during use, to an external pump or an implantable pump (figure 3, item 308; paragraph [0022]-[0023]; coupled via the container 304).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber of the container which is connected to the infusion lumen of the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado to be connected to an implantable pump, therefore resulting in wherein a proximal end of the infusion lumen is coupled, during use, to an external pump or an implantable pump, as taught by the second embodiment of Geiger, for the purpose of controlling a rate of delivery of a drug/effectively delivery a drug by using a pump (paragraph [0023] of Geiger). Examiner notes since the infusion lumen of the first embodiment of Geiger is configured such that the infusion lumen is not in fluid communication with the sampling reservoir, and the chamber of the container connected to the infusion lumen is modified in view of the second embodiment of Geiger to be coupled to an external pump or an implantable pump, the infusion lumen as a result would be configured such that the external pump or the implantable pump is not in fluid communication with the sampling reservoir.
In regard to claim 3,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1, wherein the aspiration lumen and the infusion lumen are positioned adjacent and coupled to one another (see figure 2 and paragraph [0016] of Geiger).
In regard to claim 4,
[AltContent: textbox (Tip of aspiration lumen)][AltContent: textbox (Tip of infusion lumen)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Distal end of aspiration lumen)][AltContent: ][AltContent: textbox (Distal end of infusion lumen)][AltContent: ]
PNG
media_image1.png
325
97
media_image1.png
Greyscale
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1, wherein the aspiration lumen and infusion lumen are different lengths (see analysis of claim 1 above and figure 7 of Mahurkar), and have different tip locations (see figure 7 of Mahurkar above; Examiner notes the tip locations are claimed as being of the aspiration lumen and infusing lumen. The tips labeled above are at the end the aspiration lumen and the end of the infusing lumen) when positioned, during use, in the subject's brain (see analysis of claim 1 above, wherein the device of Geiger is fully capable of being positioned during use, in the subject's brain as supported by figure 2 of Geiger) such that the distal end of the aspiration lumen and the distal end of the infusion lumen are positioned a distance away from one another (see figure 7 of Mahurkar above and analysis of claim 1 above).
In regard to claim 8,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1, wherein at least a portion of the container is formed from a material that is penetrable by a needle and substantially reseals after extraction of the needle (see analysis of claim 1 above and paragraph [0026] of John).
In regard to claim 9,
[AltContent: textbox (Barrier )][AltContent: textbox (Enlarged view of figure 2)][AltContent: arrow]
PNG
media_image2.png
312
395
media_image2.png
Greyscale
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1, wherein the container comprises a barrier (see enlarged view of figure 2 above of Geiger) positioned between a proximal opening of the aspiration lumen and at least a portion of the infusion lumen adjacent to and/or associated with the container (see enlarged view of figure 2 above of Geiger and paragraph [0016] of Geiger).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Geiger (U.S. PG publication 20090131857) in view of Mahurkar (U.S. Patent no 4583968) as evidenced by Mahurkar951 (U.S. Patent no 5197951) in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) in view of the second embodiment of Geiger (U.S. PG publication 20090131857) further in view of Sansoucy (U.S. PG publication 20140012209).
In regard to claim 6,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1.
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger is silent as to wherein at least one of the first opening or the plurality of second openings is inhibited from opening except when pressure is applied to the at least one of the first opening or the plurality of second openings.
Sansoucy teaches wherein at least one of the first opening (see opening in figure 3B when valve 120 has opened to allow fluid to enter the lumen 114; paragraph [0053]) or the plurality of second openings is inhibited from opening except when pressure is applied to the at least one of the first opening or the plurality of second openings (paragraph [0053]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to include at least one of the first opening or the plurality of second openings is inhibited from opening except when pressure is applied to the at least one of the first opening or the plurality of second openings, as taught by Sansoucy, for the purpose of preventing fluid from leaking out or entering a lumen until desired (paragraph [0006] of Sansoucy).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Geiger (U.S. PG publication 20090131857) in view of Mahurkar (U.S. Patent no 5197951) as evidenced by Mahurkar951 (U.S. Patent no 5197951) in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) in view of the second embodiment of Geiger (U.S. PG publication 20090131857) further in view of Moden (U.S. Patent no 4767410) as evidenced by Bark (U.S. Patent no 4904241).
In regard to claim 10,
[AltContent: textbox (Barrier )][AltContent: textbox (Enlarged view of figure 2)][AltContent: arrow]
PNG
media_image2.png
312
395
media_image2.png
Greyscale
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1, wherein the container comprises a barrier (see enlarged view of figure 2 above of Geiger) positioned between a proximal opening of the aspiration lumen and at least a portion of the infusion lumen adjacent to and/or associated with the container (see enlarged view of figure 2 above of Geiger).
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger is silent as to wherein the barrier is configured to inhibit penetration of a surgical instrument and/or contamination of the infusion lumen.
Moden teaches wherein the barrier (figure 8, item 76; column 7, line 3-11) is configured to inhibit penetration of a surgical instrument and/or contamination of the infusion lumen (figure 8, item 80; column 7, line 3-11; Examiner notes due to the structure of the barrier as disclosed in column 7, line 3-11, the barrier is fully capable of inhibiting penetration of a surgical instrument (like a needle) since the barrier is impenetrable and further as evidenced by Bark who supports that when a needle 44 comes in contact with an impenetrable barrier 24 the needle is deflected or prevented from passing, see column 4, line 44-52 of Bark).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the barrier of the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to be an impenetrable material, as taught by Moden as evidenced by Bark, therefore resulting in wherein the barrier is configured to inhibit penetration of a surgical instrument and/or contamination of the infusion lumen for the purpose of utilizing a secure barrier that is impenetrable to separate the container (column 7, line 3-11 of Moden).
Claims 11 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Geiger (U.S. PG publication 20090131857) in view of Mahurkar (U.S. Patent no 5197951) as evidenced by Mahurkar951 (U.S. Patent no 5197951) in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) in view of the second embodiment of Geiger (U.S. PG publication 20090131857) further in view of Beling (U.S. PG publication 20140276473).
In regard to claim 11,
[AltContent: textbox (Barrier )][AltContent: textbox (Enlarged view of figure 2)][AltContent: arrow]
PNG
media_image2.png
312
395
media_image2.png
Greyscale
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1, wherein the container comprises a barrier (see enlarged view of figure 2 above of Geiger) positioned between a proximal opening of the aspiration lumen and at least a portion of the infusion lumen adjacent to and/or associated with the container (see enlarged view of figure 2 above of Geiger).
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger fails to disclose wherein the container comprises a marker to indicate a position of the barrier and/or a center of the container to target aspiration.
Beling teaches wherein the container (see figure 2 which shows a container and figure 3A-3B which shows a portion of the container) comprises a marker (figure 3A and 3B, item 40 and 40E; paragraph [0032] and [0029]) to indicate a position of the barrier and/or a center of the container to target aspiration (see figure 2 and 3A and 3B: wherein a center of the container is indicated by the marker; paragraph [0032]; see paragraph [0002] wherein fluid may be removed from the reservoir).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the container of the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to include wherein the container comprises a marker to indicate a position of the barrier and/or a center of the container to target aspiration, as taught by Beling, for the purpose of enhancing visibility and providing guidance to a user inserting a needle (paragraph [0006] and [0008] of Beling).
In regard to claim 25,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger in view of Beling teaches the intraventricular access device of claim 11, wherein the marker provides radiographic opacity (see analysis of claim 11 above and paragraph [0032] and [0029] of Beling).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Geiger (U.S. PG publication 20090131857) in view of Mahurkar (U.S. Patent no 5197951) as evidenced by Mahurkar951 (U.S. Patent no 5197951) in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) in view of the second embodiment of Geiger (U.S. PG publication 20090131857) further in view of Dextradeur (U.S. PG publication 20130253266).
In regard to claim 12,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1.
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger is silent as to wherein at least portions of the device are formed from and/or coated in biocompatible materials which inhibit cell adhesion and/or biocompatible materials which comprise an antimicrobial.
Dextradeur teaches wherein at least portions of the device (figure 1, item 10) are formed from and/or coated in biocompatible materials which inhibit cell adhesion and/or biocompatible materials which comprise an antimicrobial (paragraph [0031]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to include wherein at least portions of the device are formed from and/or coated in biocompatible materials which inhibit cell adhesion and/or biocompatible materials which comprise an antimicrobial, as taught by Dextradeur, for the purpose of protecting against unwanted bacteria/organisms (paragraph [0031] of Dextradeur).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Geiger (U.S. PG publication 20090131857) in view of Mahurkar (U.S. Patent no 5197951) as evidenced by Mahurkar951 (U.S. Patent no 5197951) in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) in view of the second embodiment of Geiger (U.S. PG publication 20090131857) further in view of Eliasen (U.S. PG publication 20060084929).
In regard to claim 24,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1.
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger fails to disclose wherein the container includes a cone-shape guide member to guide a needle toward the aspiration lumen.
Eliasen teaches wherein the container (see figure 4) includes a cone-shape guide member (figure 4, item 34a-34e; paragraph [0032] wherein item 34a-e are shaped like a cone) to guide a needle (paragraph [0032]) toward the aspiration lumen (lumen attached to item 16 can be used for aspiration; paragraph [0020]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to include wherein the container includes a cone-shape guide member to guide a needle toward the aspiration lumen, as taught by Eliasen, for the purpose of facilitating needle insertion and enabling a reservoir to be cleared or flushed with less fluid (paragraph [0032] and [0034] of Eliasen).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Geiger (U.S. PG publication 20090131857) in view of Mahurkar (U.S. Patent no 4583968) as evidenced by Mahurkar951 (U.S. Patent no 5197951) in view of John (U.S. PG publication 20050070458) as evidenced by Delgado (U.S. Patent no 3640269) in view of the second embodiment of Geiger (U.S. PG publication 20090131857) further in view of Spencer (U.S. Patent no 3888249).
In regard to claim 26,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 1.
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger fails to disclose wherein the plurality of second openings includes a plurality of slits.
Spencer teaches wherein the plurality of second openings includes a plurality of slits (figure 2, item 24; column 2, line 37-48).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of second openings of the first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to be a plurality of slits, as taught by Spencer, for the purpose of preventing unwanted retrograde flow and blockage (column 1, line 47-58 of Spencer).
In regard to claim 27,
The first embodiment of Geiger in view of Mahurkar as evidenced by Mahurkar951 in view of John as evidenced by Delgado in view of the second embodiment of Geiger in view of Spencer teaches the intraventricular access device of claim 26, wherein the plurality of slits opens when the drug is infused and closes when the drug is not infused (see analysis of claim 26 above and column 2, line 37-48 of Spencer).
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive. Although newly cited art Mahurkar (U.S. Patent no 4583968) is used to reject claim 1, Examiner will address Applicant’s arguments as they are relevant to newly cited art Mahurkar (U.S. Patent no 4583968). Applicant argues that “inhibiting cross contamination of the brain fluid and the drug” is not taught by the prior art. Geiger (U.S. PG publication 20090131857) discloses an aspiration lumen aspirating brain fluid and an infusion lumen infusing a drug as detailed in the rejection of claim 1 above. Both Mahurkar and Geiger are drawn to double lumen catheters used for aspiration and infusion. When the first opening and the second opening of Geiger are modified in view of Mahurkar, the resulting intraventricular access device has the first opening and the plurality of second openings directed in substantially opposing directions to inhibit cross contamination of the brain fluid and the drug (i.e the fluid aspirated and infused in Geiger). The teachings of Mahurkar are being used to modify the location and number of openings of Geiger. The fluid that is aspirated/infused, that Applicant argues is now positively required, is taught by Geiger and is not modified by Mahurkar. Additionally, claim 1 is not a method claim. It is noted that “to inhibit cross contamination of the brain fluid and the drug” is a functional limitation. Applicant argues that the dependent claims depend from an allowable base claim. See response to arguments above in regard to claim 1. As claim 1 has not been found allowable, the dependent claims are not allowable due to their dependence on claim 1. Applicant argues that new claims 24-27 are allowable because of the additional subject matter they recite. This argument is not found to be persuasive as no specific arguments have been provided in regard to claim 24-27. Claims 24-27 have been rejected above over newly cited art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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 at (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.
/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights