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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/14/2026 has been entered.
Response to Amendment
The Amendment filed on 7/14/2026 has been entered. Claims 1-4, 6-13, 15-19, 22, 24-27 remain pending in the application. Claims 2, 7, 13, 15-19, and 22 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 10/10/2023.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 Final Office Action mailed 4/15/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/14/2026 and 7/21/2026 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, 6, 8-12, and 24-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claim 1,
Line 7-9 recites “the bent portions arranged such that the first opening and the plurality of second openings are directed away from one another”. There is not support in the original disclosure for this limitation. Paragraph [0068] of the disclosure states “In some embodiments, a distal end of the aspiration lumen comprises a first opening and a distal end of the infusion lumen comprises a second opening. The first opening and the second opening may be directed in a substantially opposing directions (e.g., at least orthogonally relative to one another) to inhibit cross contamination of fluids. The openings may be directed away from one another by bending (e.g., during fabrication and/or implantation) at least a portion of at least one of the distal ends of the aspiration and/or infusion lumen”. Support does not appear to be present for the bent portions arranged such that the first opening and the plurality of second openings are directed away from one another. Support does appear to be present for the bent portions arranged such that the first opening and a second opening are directed away from one another. Figure 9 shows a plurality of openings, but the plurality of opening do not appear to be on a bent portion. Figure 7 is referenced by Applicant as providing support (see page 15 of the remarks filed 7/14/2026). Figure 7 however does not appear to show a plurality of second openings and a first opening directed away from one another. Appropriate correction is required.
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, 8-9, and 26 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 Clark (U.S. Patent no 7569029) further in view of Clark (U.S. Patent no 9333321) 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 Clark (U.S. Patent no 9333321) will be referred to as Clark321.
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]) for aspirating a brain fluid (cerebrospinal fluid; paragraph [0016] and [0018]) and an infusion lumen (lumen used to infuse drug paragraph [0016]-[0017]) for 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 a distal end of the infusion lumen comprises a second 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 a distal end of the infusion lumen comprises a plurality of second openings, the distal end of the aspiration lumen and the distal end of the infusion lumen each having a bent portion, the bent portions arranged such that the first opening and the plurality of second openings are directed away from one another 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.
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Clark teaches a distal end of the infusion lumen (figure 4, item 16) comprises a second opening (figure 4, item 22), the distal end of the aspiration lumen (figure 4, item 14) and the distal end of the infusion lumen each having a bent portion (see figure 3, item 20 and figure 4, item 18), the bent portions arranged such that the first opening (figure 4, item 24) and the second opening (figure 4, item 22) are directed away from one another (see figure 3 and 4) to inhibit cross contamination of a first fluid and a second fluid (column 6, line 57-column 7, line 8 and column 5, line 13-19).
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 distal end of the aspiration lumen of Geiger, which is used to aspirate a brain fluid, to include a bent portion and to modify the distal end of the infusion lumen of Geiger, which is used to infuse a drug, to include a bent portion and to modify the placement of the first opening and the second opening to be axially displaced from one another, as taught by Clark, therefore resulting in the distal end of the aspiration lumen and the distal end of the infusion lumen each having a bent portion, the bent portions arranged such that the first opening and the second opening are directed away from one another 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 maximizing control and direction of fluid into and out from the lumen ports to prevent unwanted mixing (column 6, line 57-column 7, line 8 and column 5, line 13-19 of Clark).
The first embodiment of Geiger in view of Clark is silent as to the reservoir is specifically for sampling and fails to disclose a distal end of the infusion lumen comprises a plurality of second openings, 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 in view of Clark is also silent as to the bent portions arranged such that the first opening and the plurality of second openings are directed away from one another and a container forming a sampling reservoir and wherein the proximal end of the aspiration lumen is in fluid communication with the sampling reservoir.
Clark321 teaches a distal end of the infusion lumen (figure 7A, item 72) comprises a plurality of second openings (item 76 and one or more side holes 79; column 9, line 64-column 10, line 3; see also the embodiments in figure 8A and 6D which show an example placement of side hole 89 on the infusion lumen and side hole 69 on the infusion lumen).
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 distal end of the infusion lumen of Geiger in view of Clark, which is used to infuse a drug, to include a plurality of second openings, as taught by Clark321, therefore resulting in the bent portions arranged such that the first opening and the plurality of second openings are directed away from one another, for the purpose of providing additional means of fluid exchange (column 9, line 66-column 10, line 3 of Clark321 and column 9, line 14-24 of Clark321).
The first embodiment of Geiger in view of Clark in view of Clark321 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 in view of Clark in view of Clark321 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 Clark in view of Clark321, 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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, see also figure 4 of Clark).
In regard to claim 4,
The first embodiment of Geiger in view of Clark in view of Clark321 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 3 and 4 of Clark), and have different tip locations (see analysis of claim 1 above and figure 3 and 4 of Clark) 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 analysis of claim 1 above and figure 3 and 4 of Clark).
In regard to claim 8,
The first embodiment of Geiger in view of Clark in view of Clark321 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,
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The first embodiment of Geiger in view of Clark in view of Clark321 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 and paragraph [0016] of Geiger).
In regard to claim 26,
The first embodiment of Geiger in view of Clark in view of Clark321 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 plurality of second openings includes a plurality of slits (wherein the one or more side openings are slits therefore resulting in a plurality of slits; column 9, line 19-24 of Clark321).
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 Clark (U.S. Patent no 7569029) in view of Clark321 (U.S. Patent no 9333321) 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark (U.S. Patent no 7569029) in view of Clark321 (U.S. Patent no 9333321) 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,
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The first embodiment of Geiger in view of Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark (U.S. Patent no 7569029) in view of Clark321 (U.S. Patent no 9333321) 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,
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The first embodiment of Geiger in view of Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark (U.S. Patent no 7569029) in view of Clark321 (U.S. Patent no 9333321) 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321in 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 Clark (U.S. Patent no 7569029) in view of Clark321 (U.S. Patent no 9333321) 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 Clark in view of Clark321 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 Clark in view of Clark321 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 Clark in view of Clark321 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).
Claim 27 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 Clark (U.S. Patent no 7569029) in view of Clark321 (U.S. Patent no 9333321) 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 27,
The first embodiment of Geiger in view of Clark in view of Clark321 in view of John as evidenced by Delgado in view of the second embodiment of Geiger teaches the intraventricular access device of claim 26.
The first embodiment of Geiger in view of Clark in view of Clark321 in view of John as evidenced by Delgado in view of the second embodiment of Geiger is silent as to wherein the plurality of slits is configured to open when the drug is infused and close when the drug is not infused.
Spencer teaches wherein the plurality of slits (figure 2, item 24; column 2, line 37-48) is configured to open when the drug is infused and close when the drug is not infused (column 2, line 37-48 of Spencer).
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 slits of the first embodiment of Geiger in view of Clark in view of Clark321 in view of John as evidenced by Delgado in view of the second embodiment of Geiger to be configured to open when the drug is infused and close when the drug is not infused, as taught by Spencer, for the purpose of preventing unwanted retrograde flow and blockage (column 1, line 47-58 of Spencer).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-4, 6, 8-12, and 24-27 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kurrus (U.S. PG publication 20140221898) discloses the distal end of the aspiration lumen (figure 3, item 54) and the distal end of the infusion lumen (figure 3, item 56) each having a bent portion (see figure 3), the bent portions arranged such that the first opening and the second opening are directed away from one another (see figure 3).
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.
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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.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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