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
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/30/2026.
Applicant’s election without traverse of Group I in the reply filed on 6/30/2026 is acknowledged.
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, 6-9, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Huiszoon et al. (US 20190060556 A1) in view of Pepin (US 20080097296 A1) further in view of Schultheis (US 20210307828 A1).
Regarding claim 1, Huiszoon discloses a catheter system (Figs. 9A-9C), comprising:
a catheter (906) comprising:
a catheter tube (Tube of 906) configured for placement within a patient body (Fig. 9A), the catheter tube comprising a distal tip (906c); and
a luminal wall (906a) defining a lumen (906b) extending along the catheter tube, and
a system module (910) coupled with the catheter (Figs. 9A-9C), comprising:
first and second electrodes (104/106/916a/916b) disposed within the lumen (Paragraphs [0027] and [0077]), wherein:
the first and second electrodes are coupled with the luminal wall adjacent the distal tip (Paragraph [0077]), and
the second electrode spaced away from the first electrode (Paragraphs [0029] and [0077], Fig. 9A); and
a console (112/110/926) coupled with the first and second electrodes (Fig. 9A, Paragraph [0077]), the console including
a processor and a memory having logic stored thereon that, when executed by the processor, performs operations that include determining an electrical impedance between the first and second electrodes (Paragraphs [0031], [0041], and [0077]).
Huiszoon is silent regarding the luminal wall defining the lumen extending along the catheter tube between a hub and distal tip and wherein the system module is configured for placement within the patient body.
In analogous art, Pepin teaches a catheter (10, Figs. 1-2) comprising a catheter tube (12); and a luminal wall (Wall of 12) defining a lumen (13) extending along the catheter tube between a hub (20) and distal tip (19, Figs. 1-2, Paragraph [0025]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter system and lumen of Huiszoon to incorporate the teachings of Pepin to incorporate a hub and the lumen extending along the catheter tube between the hub and the distal tip in order to allow a pathway to allow for a medical device to extend through the catheter or provide a path for fluid to enter the catheter (Paragraph [0027]).
Huiszoon in view of Pepin are silent regarding wherein the system module is configured for placement within the patient body.
In analogous art, Schultheis teaches a system controller (126) can be provided within the catheter system (100, Paragraph [0059]) and the impedance detector (162) can be positioned inside the catheter (102, Paragraph [0085]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system module of Huiszoon to incorporate the teachings of Schultheis to being configured for placement within the patient body since mere rearrangement of the essential working parts of a device involves only routine skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 2, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, wherein the change in the electrical impedance is caused by at least one of a thrombus formation or a bacterial adhesion within the lumen (Paragraphs [0003] and [0033], Huiszoon).
Regarding claim 6, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, wherein the operations further include: comparing a determined electrical impedance with an impedance limit stored in the memory; and as a result of the comparison, providing a notification when the determined electrical impedance exceeds the impedance limit (Fig. 2A, Paragraphs [0032] and [0041], Huiszoon).
Regarding claim 7, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 6, wherein: the console includes a wireless module (928/“Bluetooth” Paragraph [0033], Huiszoon), and providing a notification includes wirelessly providing the notification to an external computing device (930/114, Paragraphs [0033] and [0079]-[0080], Huiszoon).
Regarding claim 8, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, wherein: the first electrode receives an excitation voltage from the console, and the console receives a signal from the second electrode (Paragraphs [0030], [0044], and [0077], Huiszoon).
Regarding claim 9, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, but are silent regarding wherein at least a portion of each the first and second electrodes is embedded within the luminal wall.
Huiszoon discloses that the substrate conforms to the surface of the indwelling medical device, thereby minimizing or at least reducing obstruction of the indwelling medical device. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the substrate/electrodes of Huiszoon to incorporate having at least a portion of each the first and second electrodes is embedded within the luminal wall since mere rearrangement of the essential working parts of a device involves only routine skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 11, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, wherein the system module is disposed adjacent the distal tip (Fig. 9A, Huiszoon).
Regarding claim 12, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, but are silent regarding wherein the system module is embedded within the luminal wall.
Huiszoon discloses that the substrate conforms to the surface of the indwelling medical device, thereby minimizing or at least reducing obstruction of the indwelling medical device. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the substrate/electrodes of Huiszoon to incorporate having at least a portion of each the first and second electrodes is embedded within the luminal wall since mere rearrangement of the essential working parts of a device involves only routine skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20160067464 A1) in view of Huiszoon et al. (US 20190060556 A1) further in view of Pepin (US 20080097296 A1).
Regarding claim 1, Kim discloses a catheter system (Fig. 2B), comprising:
a catheter (207) comprising:
a catheter tube (207) configured for placement within a patient body, the catheter tube comprising a distal tip (Fig. 2A); and
a luminal wall (Wall of 207) defining a lumen (Interior or 207) extending along the catheter tube (Figs. 2A-2B), and
a system module (103/203/201) coupled with the catheter (Fig. 2B), comprising:
first and second electrodes (103/203) disposed within the lumen (Fig. 2B), wherein:
the first and second electrodes are coupled with the luminal wall adjacent the distal tip (Fig. 2B, Paragraph [0039]), and
the second electrode spaced away from the first electrode (Fig. 2B); and
a console (201) coupled with the first and second electrodes (Fig. 2B), the console including
an impedance measurement instrument (201) that include determining an electrical impedance between the first and second electrodes (Paragraph [0040]).
Kim is silent regarding
a processor and a memory having logic stored thereon that, when executed by the processor, performs operations that include determining an electrical impedance between the first and second electrodes.
In analogous art, Huiszoon teaches a processor and a memory having logic stored thereon that, when executed by the processor, performs operations that include determining an electrical impedance between first and second electrodes (Paragraphs [0031], [0041], and [0077]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the console of Kim to incorporate the teachings of Huiszoon to incorporate a processor and a memory having logic stored thereon that, when executed by the processor, performs operations that include determining an electrical impedance the between first and second electrodes in order to automatically control the impedance measurement and processing the resulting impedance data, thereby reducing the need for manual impedance measurement and facilitating automated monitoring of conditions within the catheter lumen.
Kim in view of Huiszoon are silent regarding the luminal wall defining the lumen extending along the catheter tube between a hub and distal tip and wherein the system module is configured for placement within the patient body.
In analogous art, Pepin teaches a catheter (10, Figs. 1-2) comprising a catheter tube (12); and a luminal wall (Wall of 12) defining a lumen (13) extending along the catheter tube between a hub (20) and distal tip (19, Figs. 1-2, Paragraph [0025]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter system and lumen of Kim in view of Huiszoon to incorporate the teachings of Pepin to incorporate a hub and the lumen extending along the catheter tube between the hub and the distal tip in order to allow a pathway to allow for a medical device to extend through the catheter or provide a path for fluid to enter the catheter (Paragraph [0027]).
Kim in view of Huiszoon further in view of Pepin are silent regarding wherein the system module is configured for placement within the patient body.
In analogous art, Schultheis teaches a system controller (126) can be provided within the catheter system (100, Paragraph [0059]) and the impedance detector (162) can be positioned inside the catheter (102, Paragraph [0085]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system module of Kim in view of Huiszoon to incorporate the teachings of Schultheis to being configured for placement within the patient body since mere rearrangement of the essential working parts of a device involves only routine skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 3, Kim in view of Huiszoon further in view of Pepin further in view of Schultheis disclose the system according to claim 1, wherein the operations include determining a first electrical impedance (501, Kim) in accordance with a solution disposed within the lumen (The combination of Kim in view of Huiszoon would teach this limitation because Kim teaches that the electrochemical impedance of the solution spanning between the immersed electrodes may be monitored (Paragraph [0040]) and that the impedance response is dominated by the solution by the solution resistance of the electrolyte between the electrodes (Paragraph [0042]). Kim further describes a baseline impedance and subsequent increases from that baseline as obstruction develops (Paragraph [0044]). Huiszoon provides the processor/controller-based implementation where the controller executes stored instructions to acquire an impedance measurement between the electrodes and process that measurement. Therefore, Kim teaches determining a baseline impedance associated with a solution occupying the catheter lumen while Huiszoon teaches implementing the impedance determination as process-executed operations).
Regarding claim 4, Kim in view of Huiszoon further in view of Pepin further in view of Schultheis disclose the system according to claim 3, wherein determining an electrical impedance includes determining a change in electrical impedance away from the first electrical impedance (The combination of Kim in view of Huiszoon would teach this limitation because Kim teaches a baseline impedance and determining the change/deviation of measured impedance from the baseline impedance (Paragraph [0044]) and Huiszoon provides the processor/controller-based implementation for obtaining impedance measurements from the electrodes).
Regarding claim 5, Kim in view of Huiszoon further in view of Pepin further in view of Schultheis disclose the system according to claim 4, wherein the change in electrical impedance includes an increase in electrical impedance (The combination of Kim in view of Huiszoon would teach this limitation because Kim teaches determining an electrical impedance and determining a change in the electrical impedance relative to a baseline impedance, wherein the change includes an increase in impedance (Paragraph [0044]) and Huiszoon provides the processor/controller-based implementation for obtaining impedance measurements from the electrodes).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Huiszoon et al. (US 20190060556 A1) in view of Pepin (US 20080097296 A1) further in view of Schultheis (US 20210307828 A1) further in view of Merz et al. (US 20100010327 A1).
Regarding claim 10, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 1, but are silent regarding wherein the system module is disposed radially inward of an outside surface of the catheter tube.
In analogous art, Merz teaches a processing unit (135) that is disposed radially inward of an outside surface of the catheter tube (111, Fig. 5). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system module of Huiszoon to incorporate the teachings of Merz to being disposed radially inward of an outside surface of the catheter tube since mere rearrangement of the essential working parts of a device involves only routine skill in the art In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Huiszoon et al. (US 20190060556 A1) in view of Pepin (US 20080097296 A1) further in view of Schultheis (US 20210307828 A1) further in view of Klubben III (US 20230001137 A1) further in view of Tan (US 7356368 B2).
Regarding claim 13, Huiszoon in view of Pepin further in view of Schultheis disclose the system according to claim 2, but are silent regarding further comprising a secondary system including a light activated surface coating applied to an inside surface of the luminal wall, the operations further including energizing a light source of the console to activate the surface coating, wherein activating the surface coating releases an agent configured to reduce effects of the at least one of a thrombus formation or a bacterial adhesion within the lumen.
In analogous art, Klubben III teaches a catheter system (100), comprising:
a catheter (102) comprising:
a catheter tube (102) configured for placement within a patient body (Fig. 1), the catheter tube comprising a distal tip (102b); and
a luminal wall (Wall of 102) defining a lumen (Interior of 102) extending along the catheter tube (Fig. 1), and
a secondary system (128) including a light activated surface coating (128) applied to an inside surface (122) of the luminal wall (Paragraph [0025]), the operations further including energizing a light source (108) of the console to activate the surface coating (Paragraph [0025]), wherein when illuminated, the photo-activated substance can prevent thrombi formation (Paragraph [0025]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Huiszoon in view of Pepin further in view of Schultheis to incorporate the teachings of Klubben III to incorporate a secondary system including a light activated surface coating applied to an inside surface of the luminal wall, the operations further including energizing a light source of the console to activate the surface coating, wherein when illuminated, the photo-activated substance can prevent thrombi formation in order to prevent thrombi formation (Paragraph [0025]).
Huiszoon in view of Pepin further in view of Schultheis further in view of Klubben III are silent regarding
wherein activating the surface coating releases an agent configured to reduce effects of the at least one of a thrombus formation or a bacterial adhesion within the lumen.
In analogous art, Tan teaches a coating made with a polymeric material including therapeutic agent which is attached by light reactive pendant chains to a surface of a medical device, wherein the coating will release the agent upon exposure to light energy, wherein activating the surface coating releases an agent configured to reduce effects of thrombus formation (Col 17, lines 5-17 and col 21, lines 40-44).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the surface coating of Klubben III to incorporate the teachings of Tan to incorporate releasing an agent in order to prevent the formation of thrombus (Col 17, lines 5-17 and col 21, lines 40-44).
Regarding claim 14, Huiszoon in view of Pepin further in view of Schultheis disclose in view of Klubben III further in view of Tan disclos the system according to claim 13, where in the agent includes at least one of an active pharmaceutical ingredient (Col 17, lines 5-17 , Tan) or an anti-coagulant agent.
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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