DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of species A and species F in the reply filed on 6/8/2026 is acknowledged. The traversal is on the grounds that the Office does not establish that the identified species are patentably distinct and does not demonstrate a serious search burden. This is not found persuasive because as stated in the restriction requirement “The species are independent or distinct because they have mutually exclusive characteristics regarding the system and protective covering”. For example, in species A, a system with a single dual lumen catheter has mutually exclusive characteristics from species B-E due to the system requiring a single dual lumen catheter. For example, a system with a single dual lumen catheter (species A) would not read on a system with two catheters each having a single lumen (species B). Applicant argues that a serious search burden was not established since the restriction requirement does not identify any separate classification, different field or search, or distinct examination issues applicable to the identified species. As stated in the restriction requirement, “There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (E.G. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries); and/or prior art applicable to one group would not likely be applicable to another group.” As stated in MPEP 808.02 “Patents need not be cited to show different fields of search”. Due to the mutually exclusive characteristics, a different field of search is required. For example, dual lumen catheters would need to be searched for the species that require a dual lumen catheter, while single lumen catheters would need to be searched for the species that require a single lumen catheter.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8 and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/8/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/25/2024, 9/17/2025, and 5/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
It is noted that Applicant has submitted 227 pages of IDS with hundreds of references. Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
Specification
The abstract of the disclosure is objected to because:
Line 1 recites “the skull”. As the skull has not been previously introduced, Examiner suggests replacing “the skull” with “a skull” to put the abstract in clearer form.
Line 3 recites “The first connector”. Line 2 recites “a first catheter connector”. Examiner suggests replacing “The first connector” with “The first catheter connector” to put the abstract in clearer form and clearly refer to the first catheter connector.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 7 objected to because of the following informalities:
Line 2 recites “the device housing”. A housing is introduced in claim 1. Examiner suggests replacing “the device housing” in line 2 of claim 7 with “the housing of the device” to put the claim in clearer form by clearly referring to the housing.
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 1-7, 9-13, 18-23, and 25 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 15 recites “the first connector”. There is insufficient antecedent basis for the limitation in this claim. Line 5 recites “a first catheter connector”. It is unclear if the first connector of line 15 is the same or different than the first catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first connector” in line 15 of claim 1 with “the first catheter connector”.
In regard to claim 3,
Line 2 recites “the first catheter connection port”. There is insufficient antecedent basis for the limitation in this claim. Claim 3 depends on claim 1. Claim 1 introduces a first catheter connector. It is unclear if the first catheter connection port is the same or different than the first catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first catheter connection port” in line 2 of claim 3 with “the first catheter connector”.
In regard to claim 5,
Line 1 recites “a second protective covering”. Claim 5 depends on claim 1. Claim 1 does not require a protective covering. It is unclear by stating “a second protective covering” if a first protective covering is also required. For examination purposes Examiner construes a single protective covering to be required in claim 5.
Line 2 recites “the second catheter connection port”. There is insufficient antecedent basis for the limitation in this claim. Claim 5 depends on claim 1. Claim 1 introduces a second catheter connector. It is unclear if the second catheter connection port is the same or different than the second catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the second catheter connection port” in line 2 of claim 5 with “the second catheter connector”.
In regard to claim 7,
Line 2-3 recites “the second protective covering”. There is insufficient antecedent basis for the limitation in this claim. Claim 7 depends on claim 3 and claim 1. The second protective covering is introduced in claim 5. For examination purposes Examiner construes “the second protective covering” to be “a second protective covering”.
In regard to claim 9,
Line 3 recites “the first catheter connection port”. There is insufficient antecedent basis for the limitation in this claim. Claim 9 requires the limitations of claim 1. Claim 1 introduces a first catheter connector. It is unclear if the first catheter connection port is the same or different than the first catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first catheter connection port” in line 3 of claim 9 with “the first catheter connector”.
Line 5 recites “the second catheter connection port”. There is insufficient antecedent basis for the limitation in this claim. Claim 9 requires the limitations of claim 1. Claim 1 introduces a second catheter connector. It is unclear if the second catheter connection port is the same or different than the second catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the second catheter connection port” in line 5 of claim 9 with “the second catheter connector”.
In regard to claim 10,
Line 3 recites “the dual lumen catheter”. There is insufficient antecedent basis for the limitation in this claim. Claim 10 depends on claim 9. Claim 9 requires a first dual lumen catheter. It is unclear if the dual lumen catheter of line 3 of claim 10 is the same or different than the first dual lumen catheter. For examination purposes Examiner construes them to be the same. Examiner suggest replacing “the dual lumen catheter” in line 3 of claim 10 with “the first dual lumen catheter”
Line 4-5 recites “the first port of the device”. There is insufficient antecedent basis for the limitation in this claim. Claim 10 depends on claim 9 and requires the limitations of claim 1. Claim 1 introduces a first catheter connector. It is unclear if “the first port of the device” is the same or different than the first catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first port of the device” in line 4-5 of claim 10 with “the first catheter connector”. Examiner notes “the first port” in claim 12 should also be amended accordingly to state “the first catheter connector”.
In regard to claim 13,
Line 1-2 recites “wherein the portion of the first dual lumen catheter that is resistant to puncture by the needle extends from an end of the single lumen catheter”. It is unclear what is meant by this. It is unclear how the portion of the first dual lumen catheter extends from an end of the single lumen catheter. Based on the disclosure it appears the portion of the first dual lumen catheter that is resistant to puncture by the needle extends from an end of the first dual lumen catheter. Appropriate correction is required. For examination purposes Examiner construes the portion of the first dual lumen catheter that is resistant to puncture by the needle to extend indirectly from an end of the single lumen catheter.
In regard to claim 18,
Line 2 recites “the second port”. There is insufficient antecedent basis for the limitation in this claim. Claim 18 depends on claim 9 and requires the limitations of claim 1. Claim 1 introduces a second catheter connector. It is unclear if the second port is the same or different than the second catheter connector. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the second port” in line 2 of claim 18 with “the second catheter connector”.
In regard to claim 21,
Line 14 recites “a fourth lumen”. A third lumen has not been introduced. It is unclear is a third lumen is required if the lumen of the third catheter is a fourth lumen. For examination purposes Examiner construes only the first lumen, second lumen, and fourth lumen to be required. Examiner suggests amending claim 20 to require a third lumen.
In regard to claim 22,
Line 1-2 recites “a dual lumen to two single lumen catheter connector”. Claim 22 depends on claim 21. Claim 21 requires a catheter connector. It is unclear if the dual lumen to two single lumen catheter connector is an additional connector to the catheter connector of claim 21. As claim 21 requires the second catheter to be configured to be connected to the catheter connector of the access port device and claim 22 requires the dual lumen to two single lumen catheter connector configured to couple the first catheter to the second and third catheters, such that the first lumen of the first catheter is in communication with the third lumen of the second catheter and the second lumen of the first catheter is in communication with the fourth lumen of the third catheter, the catheter connector is construed to be a dual lumen to two single lumen catheter connector. Examiner suggests clarifying that the dual lumen to two single lumen catheter connector is the catheter connector.
Line 3 recites “the third lumen”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests amending claim 20 to require a third lumen of the second catheter.
In regard to claim 23,
Line 1 recites “the implantable infusion device”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if the implantable infusion device refers to the access port device or to the implantable infusion pump. For examination purposes Examiner construes “the implantable infusion device” to be “the implantable infusion pump”. Examiner suggests replacing “the implantable infusion device” in line 1 of claim 23 with “the implantable infusion pump”.
In regard to claim 25,
Line 1 recites “the implantable infusion device”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if the implantable infusion device refers to the access port device or to the implantable infusion pump. For examination purposes Examiner construes “the implantable infusion device” to be “the implantable infusion pump”. Examiner suggests replacing “the implantable infusion device” in line 1 of claim 25 with “the implantable infusion pump”.
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 1-2, 9-10, 12-13, 18-20, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lobl (U.S. PG publication 20070255237) further in view of Otto (U.S. PG publication 20210252266).
In regard to claim 1,
Lobl discloses a device (see all of figure 16 not including catheter 102) configured to be implanted between a scalp and a skull of a subject (paragraph [0010], [0031], [0066] and [0074]; Examiner notes “configured to be implanted between a scalp and a skull of a subject” is a functional limitation. The device is fully capable of the recited function due to its structure as supported by paragraph [0010], [0031], [0060], [0066] and [0074]) the device comprising:
a housing (see housing formed by port 122 not including the connector that item 102 is attached to) having a bottom (see figure 15 and 16) configured to face the skull and a top configured to face the scalp (paragraph [0060]; Examiner notes “configured to face the skull and a top configured to face the scalp” is a functional limitation. The housing is fully capable of the recited function due to its structure as supported by paragraph [0010], [0031], [0060], [0066] and [0074]);
a first catheter connector (see catheter connector which item 102 is attached to) configured to couple to a first dual lumen catheter (figure 16, item 102; Examiner notes “configured to couple to a first dual lumen catheter” is a functional limitation and a first dual lumen catheter is not positively required by the claim. The first catheter connector is fully capable of the recited function as shown in figure 16), wherein the first catheter connector extends from the housing (see figure 15 and 16) and comprises a first lumen (see lumen of catheter connector connected to item 103) and a second lumen (see lumen of catheter connector connected to item 101);
an opening (figure 16, item 153b) defined by the top of the housing (see figure 15 and 16), wherein the opening is configured to be accessed by a needle percutaneously inserted through the scalp when the device is implanted (paragraph [0058]; Examiner notes “configured to be accessed by a needle percutaneously inserted through the scalp when the device is implanted” is a functional limitation. The opening is fully capable of the recited function due to its structure as fluid can be withdrawn as supported by paragraph [0058]. Paragraph [0039] also supports the septum can be pierced by a needle);
a first fluid pathway (figure 16, item 147b) from the first lumen of the first catheter connector to the opening defined by the top of the housing (see figure 16); and
a second fluid pathway (figure 16, item 147a) from the second lumen of the first connector (see figure 16).
Although Lobl supports that the lumen connected to the second lumen of the first connector can receive fluid from an external pump (paragraph [0058]), Lobl is silent as to a second catheter connector configured to couple to a single lumen catheter, wherein the second catheter connector extends from the housing. As a result, Lobl also fails to disclose a second fluid pathway from the second lumen of the first connector to the second catheter connector.
Otto teaches a second catheter connector (figure 3, item 60) configured to couple to a single lumen catheter (figure 3, item 65; Examiner notes “configured to couple to a single lumen catheter” is a functional limitation and the single lumen catheter is not positively required by the claim. The second catheter connector is fully capable of the recited function as shown in figure 3; Examiner notes the single lumen catheter is attached to an implantable infusion pump as detailed in paragraph [0007] and [0024]), wherein the second catheter connector extends from the housing (see figure 3), and a second fluid pathway (pathway in housing between item 70 and 60) from the first connector (figure 3, item 70) to the second catheter connector (figure 3, item 60).
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 Lobl to include a second catheter connector configured to couple to a single lumen catheter, wherein the second catheter connector extends from the housing, and to include the single lumen catheter attached to the implantable infusion pump, as taught by Otto, therefore resulting in a second catheter connector configured to couple to a single lumen catheter, wherein the second catheter connector extends from the housing and a second fluid pathway from the second lumen of the first connector to the second catheter connector, for the purpose of enabling connection to an infusion pump to guarantee a constant supply of liquid (paragraph [0007] and [0011] of Otto).
In regard to claim 2,
Lobl in view of Otto teaches the device of claim 1, comprising a self-sealing septum (figure 15, item 151B of Lobl; paragraph [0039] of Lobl) disposed across the opening defined by the top of the housing (see figure 15 of Lobl; paragraph [0058] of Lobl).
In regard to claim 9,
Lobl in view of Otto teaches the system (see all of figure 16 of Lobl, the single lumen catheter 65 of Otto and implantable infusion pump of Otto as detailed in the rejection of claim 1 above; see paragraph [0024] and [0007] of Otto) comprising:
the device of claim 1 (see rejection of claim 1 above);
the first dual lumen catheter (figure 16, item 102 of Lobl) configured to connect to the first catheter connection port (see figure 15 and 16 of Lobl);
and
the single lumen catheter (figure 1, item 65 of Otto) configured to couple to the second catheter connection port (see analysis of claim 1 above and figure 1 of Otto).
In regard to claim 10,
Lobl in view of Otto teaches the system of claim 9, wherein the first dual lumen catheter comprises a first opening in communication with the first lumen (see figure 15 and 16 of Lobl), and a second opening in communication with the second lumen (see figure 15 and 16 of Lobl), and wherein the first and second openings of the dual lumen catheter are configured to be placed in a brain when the first dual lumen catheter is coupled to the first port of the device (Examiner notes “configured to be placed in a brain when the first dual lumen catheter is coupled to the first port of the device” is a functional limitation. The first and second openings of the dual lumen catheter are fully capable of recited function due to their structure. See paragraph [0010], [0031], [0066] and [0074] of Lobl).
In regard to claim 12,
Lobl in view of Otto teaches the system of claim 10, wherein a portion of the first dual lumen catheter that is configured to couple to the first port is resistant to puncture by the needle (see figure 16 of Lobl wherein a portion of the first dual lumen catheter that is within the first catheter connector is resistant to puncture by the needle due to being within the first catheter connector and protected by the first catheter connector. Examiner notes the portion is construed as being resistant to needle puncture compared to a portion of the first dual lumen catheter which is outside of the first catheter connector and less resistant to needle puncture).
In regard to claim 13,
Lobl in view of Otto teaches the system of claim 12, wherein the portion of the first dual lumen catheter that is resistant to puncture by the needle extends from an end of the single lumen catheter a distance (see analysis of claim 12, 9, and 1 above wherein the portion of the first dual lumen catheter that is resistant to puncture by the needle extends from an end of the single lumen catheter via other components a distance).
Lobl in view of Otto is silent as to a distance from 0.5 cm to 5 cm.
It would have been an obvious matter of design choice to modify Lobl in view of Otto to include a distance from 0.5 cm to 5 cm since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Lobl in view of Otto to include a distance from 0.5 cm to 5 cm since applicant has not disclosed that having a distance from 0.5 cm to 5 cm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a distance from 0.5 cm to 5 cm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 18,
Lobl in view of Otto teaches the system of claim 9, wherein a portion of the single lumen catheter that is configured to couple to the second port is resistant to puncture by the needle (see figure 3 of Otto wherein a bottom portion of the single lumen catheter 65 of Otto is resistant to puncture by the needle due to being partially protected by the housing. Examiner notes the puncture by the needle is not further defined regarding the direction/location of the puncture).
In regard to claim 19,
Lobl in view of Otto teaches the system of claim 18, wherein the portion of the single lumen catheter that is resistant to puncture by the needle extends from an end of the single lumen catheter a distance (see analysis of claim 18, 9, and 1 above).
Lobl in view of Otto is silent as to a distance from 0.5 cm to 5 cm.
It would have been an obvious matter of design choice to modify Lobl in view of Otto to include a distance from 0.5 cm to 5 cm since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Lobl in view of Otto to include a distance from 0.5 cm to 5 cm since applicant has not disclosed that having a distance from 0.5 cm to 5 cm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a distance from 0.5 cm to 5 cm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 20,
Lobl in view of Otto teaches the system of claim 9, comprising an implantable infusion pump (see analysis of claim 9 and 1 above; implantable infusion pump of Otto; see paragraph [0024] and [0007] of Otto), wherein the implantable infusion pump is configured to connect to the single lumen catheter (see analysis of claim 9 and 1 above; see paragraph [0024] and [0007] of Otto).
In regard to claim 24,
Lobl discloses a system (see all of figure 16) comprising:
an access port device (see figure 15 and 16 not including item 102) configured to be implanted between a scalp and a skull of a subject (paragraph [0010], [0031], [0060], [0066] and [0074]; Examiner notes “configured to be implanted between a scalp and a skull of a subject” is a functional limitation. The device is fully capable of the recited function due to its structure as supported by paragraph [0010], [0031], [0060], [0066] and [0074]),
the access port device comprising:
an opening (figure 16, item 153b) configured to be accessed by a needle percutaneously inserted through the scalp when the access port device is implanted (paragraph [0058]; Examiner notes “configured to be accessed by a needle percutaneously inserted through the scalp when the access port device is implanted” is a functional limitation. The opening is fully capable of the recited function due to its structure as fluid can be withdrawn as supported by paragraph [0058]. Paragraph [0039] also supports the septum can be pierced by a needle);
a catheter connector (see catheter connector which item 102 is attached to); and
a fluid pathway (figure 16, item 147b) extending from the catheter connector to the opening (see figure 16); and
a catheter (figure 15 and 16, item 102) comprising a first lumen (figure 16, item 103) and a second lumen (figure 16, item 101), wherein the catheter comprises a first opening in communication with the first lumen (see figure 15 and 16) and a second opening in communication with the second lumen (see figure 15 and 16), wherein the first and second openings are configured to be implanted in a brain of the subject (Examiner notes “configured to be implanted in a brain of the subject” is a functional limitation. The first and second openings are fully capable of the recited function due to their structure as supported by paragraph [0010], [0031], [0060], [0066] and [0074]),
wherein a first portion of the catheter comprising the first lumen is configured to be connected to the catheter connector of the access port device (see figure 15 and 16),
wherein a second portion of the catheter comprising the second lumen is configured to be connected to an infusion pump (paragraph [0055]).
Lobl is silent as to wherein a second portion of the catheter comprising the second lumen is configured to be connected to an implantable infusion pump.
Otto teaches a second lumen (figure 3, item 75) is configured to be connected to an implantable infusion pump (Examiner notes the second lumen is attached to an implantable infusion pump via item 65 and the access port device as detailed in paragraph [0007] and [0024]; see figure 3).
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 Lobl to include the second lumen is configured to be connected to an implantable infusion pump, and to include the implantable infusion pump of Otto and the catheter 65 of Otto which would be attached to item 153a of Lobl, as taught by Otto, therefore resulting in wherein a second portion of the catheter comprising the second lumen is configured to be connected to an implantable infusion pump, for the purpose of enabling connection to an implantable infusion pump to guarantee a constant supply of liquid (paragraph [0007] and [0011] of Otto).
In regard to claim 25,
Lobl in view of Otto teaches the system of claim 24, further comprising the implantable infusion device (see analysis of claim 24 above and paragraph [0007] and [0024] of Otto).
Claims 3-4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lobl (U.S. PG publication 20070255237) in view of Otto (U.S. PG publication 20210252266) further in view of Marrs (U.S. Patent no 6562023).
In regard to claim 3,
Lobl in view of Otto teaches the device of claim 1.
Lobl in view of Otto is silent as to comprising a first protective covering extending away from the opening and over the first catheter connection port a distance from 0.5 cm to 5 cm.
Marrs teaches comprising a first protective covering (figure 2, item 80) extending away from the opening and over the first catheter connection port a distance (see figure 2 and 6).
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 Lobl in view of Otto to include comprising a first protective covering extending away from the opening and over the first catheter connection port a distance, as taught by Marrs, for the purpose of supporting a catheter (column 5, line 63-column 6, line 8 of Marrs).
Lobl in view of Otto in view of Marrs is silent as to a distance from 0.5 cm to 5 cm.
It would have been an obvious matter of design choice to modify Lobl in view of Otto in view of Marrs to include a distance from 0.5 cm to 5 cm since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Lobl in view of Otto in view of Marrs to include a distance from 0.5 cm to 5 cm since applicant has not disclosed that having a distance from 0.5 cm to 5 cm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a distance from 0.5 cm to 5 cm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 4,
Lobl in view of Otto in view of Marrs teaches the device of claim 3, wherein the first protective covering comprises a bottom surface configured to be placed on the skull (see analysis of claim 3 above and figure 2 of Marrs. Examiner notes “configured to be placed on the skull” is a functional limitation. The bottom surface is fully capable of the recited function due to its structure. See also paragraph [0060] of Lobl), a top surface opposing the bottom surface (see analysis of claim 3 above and figure 2 of Marrs), and a groove formed in the bottom surface (see analysis of claim 3 above and figure 2 of Marrs), wherein the groove is configured to receive the first dual lumen catheter (see analysis of claim 3 above and figure 6 of Marrs).
In regard to claim 7,
Lobl in view of Otto in view of Marrs teaches the device of claim 3, wherein one or both of the first protective covering and the second protective covering are part of the device housing (see figure 6 of Marrs and analysis of claim 3 above wherein the first protective covering is construed to be part of the device housing; Examiner notes the second protective covering is construed as item 151a which is a part of the device housing).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lobl (U.S. PG publication 20070255237) in view of Otto (U.S. PG publication 20210252266) further in view of Nelson (U.S. PG publication 20140236091).
In regard to claim 5,
Lobl in view of Otto teaches the device of claim 1.
Lobl in view of Otto is silent as to comprising a second protective covering extending away from the opening and over the second catheter connection port a distance from 0.5 cm to 5 cm.
Nelson teaches a second protective covering (figure 1, 2, and 5, item 202, 232 and 249) extending away from the opening (see figure 2) and over the second catheter connection port (figure 2 and 5, item 204) a distance (see figure 1 and 5).
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 Lobl in view of Otto to include a second protective covering extending away from the opening and over the second catheter connection port a distance and to replace the second catheter connector with the second catheter connector 204 of Nelson and to modify the single lumen catheter accordingly, as taught by Nelson, for the purpose of providing a secure connection and immobilizing and limiting rotation (paragraph [0044], [0007], [0030], and [0049] of Nelson).
Lobl in view of Otto in view of Nelson is silent as to a distance from 0.5 cm to 5 cm.
It would have been an obvious matter of design choice to modify Lobl in view of Otto in view of Nelson to include a distance from 0.5 cm to 5 cm since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Lobl in view of Otto in view of Nelson to include a distance from 0.5 cm to 5 cm since applicant has not disclosed that having a distance from 0.5 cm to 5 cm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a distance from 0.5 cm to 5 cm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 6,
Lobl in view of Otto in view of Nelson teaches the device of claim 5, wherein the second protective covering comprises a bottom surface configured to be placed on the skull (see figure 1 and 2 of Nelson; Examiner notes “configured to be placed on the skull” is a functional limitation. The bottom surface is fully capable of the recited function due to its structure as supported by figure 1 of Nelson), a top surface opposing the bottom surface (see figure 1 and 2 of Nelson and analysis of claim 5 above), and a groove formed in the bottom surface (see figure 2 of Nelson), wherein the groove is configured to receive the single lumen catheter (see figure 1 and 2 of Nelson and analysis of claim 5 above).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lobl (U.S. PG publication 20070255237) in view of Otto (U.S. PG publication 20210252266) further in view of Volkodav (U.S. PG publication 20180071501).
In regard to claim 11,
Lobl in view of Otto teaches the system of claim 10, wherein the first dual lumen catheter has a length (see figure 15 and 16 of Lobl).
Lobl in view of Otto is silent as to wherein the first dual lumen catheter has a length from 55 millimeters to 80 millimeters.
Volkodav teaches wherein a catheter (figure 3, item 20) has a length from 55 millimeters to 80 millimeters (paragraph [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the dual lumen catheter of Lobl in view of Otto to include a length from 55 millimeters to 80 millimeters, as taught by Volkodav, for the purpose of providing a sufficient length to reach the lateral ventricle (paragraph [0023] of Volkodav). Examiner notes Lobl supports the system can be used in the brain (see paragraph [0010], [0031], [0066] and [0074] of Lobl).
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lobl (U.S. PG publication 20070255237) further in view of Dasse (U.S. Patent no 5171216) further in view of Otto (U.S. PG publication 20210252266).
In regard to claim 21,
Lobl discloses a system (see all of figure 15 and 16) comprising:
an access port device (see figure 15 and 16 not including item 102) configured to be implanted between a scalp and a skull of a subject (paragraph [0010], [0031], [0060], [0066] and [0074]; Examiner notes “configured to be implanted between a scalp and a skull of a subject” is a functional limitation. The device is fully capable of the recited function due to its structure as supported by paragraph [0010], [0031], [0060], [0066] and [0074]),
the access port device comprising:
an opening (figure 16, item 153b) configured to be accessed by a needle percutaneously inserted through the scalp when the access port device is implanted (paragraph [0058]; Examiner notes “configured to be accessed by a needle percutaneously inserted through the scalp when the access port device is implanted” is a functional limitation. The opening is fully capable of the recited function due to its structure as fluid can be withdrawn as supported by paragraph [0058]. Paragraph [0039] also supports the septum can be pierced by a needle);
a first catheter (figure 15 and 16, item 102) comprising a first lumen (figure 16, item 103) and a second lumen (figure 16, item 101), wherein the first catheter comprises a first opening in communication with the first lumen (see figure 15 and 16) and a second opening in communication with the second lumen (see figure 15 and 16), wherein the first and second openings are configured to be implanted in a brain of the subject (Examiner notes “configured to be implanted in a brain of the subject” is a functional limitation. The first and second openings are fully capable of the recited function due to their structure as supported by paragraph [0010], [0031], [0060], [0066] and [0074]);
Lobl fails to disclose the access port device comprising a catheter connector, a second catheter configured to be placed in communication with the first lumen and configured to be connected to the catheter connector of the access port device; a third catheter comprising a fourth lumen configured to be placed in communication with the second lumen of the first catheter and configured to be connected to an implantable infusion pump. As a result, Lobl also fails to disclose a fluid pathway extending from the catheter connector to the opening.
Dasse teaches the access port device (see figure 1 not including item 2, 4’ or 4) comprising a catheter connector (see connector which item 4’ is connected to in figure 1), a fluid pathway (see figure 1) extending from the catheter connector to the opening (figure 1, item 61’), and a second catheter (figure 1, item 4’) configured to be placed in communication with the first lumen (figure 1, item 26’) and configured to be connected to the catheter connector of the access port device (see figure 1); a third catheter (figure 1, item 4) comprising a fourth lumen configured to be placed in communication with the second lumen (figure 1, item 26) of the first catheter (figure 1, item 2) and configured to be connected to an infusion pump (Examiner notes “configured to be connected to an infusion pump” is a functional limitation. As item 4 is used to deliver fluid, it would be capable of being connected to an infusion pump to deliver fluid).
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 Lobl to include the access port device comprising a catheter connector, a fluid pathway extending from the catheter connector to the opening, and a second catheter configured to be placed in communication with the first lumen and configured to be connected to the catheter connector of the access port device; a third catheter comprising a fourth lumen configured to be placed in communication with the second lumen of the first catheter and configured to be connected to an infusion pump, as taught by Dasse, for the purpose of enabling simultaneous infusing and withdrawal of fluids easier (column 2, line 53-55 of Dasse). Examiner notes the second catheter would be connected to item 153b of Lobl and the third catheter would be connected to item 153a of Lobl.
Lobl in view of Dasse fails to disclose a third catheter configured to be connected to an implantable infusion pump.
Otto teaches a third catheter (figure 3, item 65) configured to be connected to an implantable infusion pump (Examiner notes the third catheter is attached to an implantable infusion pump as detailed in paragraph [0007] and [0024]; see figure 3).
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 Lobl in view of Dasse to include the third catheter configured to be connected to an implantable infusion pump, and to include the implantable infusion pump of Otto, as taught by Otto, therefore resulting in a third catheter configured to be connected to an implantable infusion pump, for the purpose of enabling connection to an implantable infusion pump to guarantee a constant supply of liquid (paragraph [0007] and [0011] of Otto).
In regard to claim 22,
Lobl in view of Dasse in view of Otto teaches the system of claim 21, further comprising a dual lumen to two single lumen catheter connector (see analysis of claim 21 above wherein the access port device functions as a dual lumen to two single lumen catheter connector; see figure 1 of Dasse) configured to couple the first catheter to the second and third catheters (see figure 1 of Dasse and analysis of claim 21 above), such that the first lumen of the first catheter is in communication with the third lumen of the second catheter (see figure 1 of Dasse and analysis of claim 21 above) and the second lumen of the first catheter is in communication with the fourth lumen of the third catheter (see figure 1 of Dasse and analysis of claim 21 above).
In regard to claim 23,
Lobl in view of Dasse in view of Otto teaches the system of claim 21, further comprising the implantable infusion device (see analysis of claim 21 above and paragraph [0007] and [0024] of Otto).
Conclusion
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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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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