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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The examiner acknowledges the amendments made to claims 12, 15, 16 and 20 with new claim 21 added and claims 1-11, 17 and 19 canceled in prosecution. Currently claims 12-16, 18, 20-21 are pending in the present application.
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.
Claim(s) 12-16, 18, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Veldhuijzen (US Patent No 20140074049) in view of Pameijer (US Patent No 20150031987) further in view of Wiley (US Patent No 3553583).
Regarding claim 12, Veldhuijzen teaches an adapter (catheter connector 1, [0027]) for use in an ECG-based catheter tip positioning system to allow a cable to be connected during catheter tip placement, disconnected after placement, and reconnected to check for catheter tip migration (see [0004]-[0006], which discloses how tip localization and positioning features are present using real time ECG readings to determine where the tip is before and after placement), the adapter comprising: a body defining a lumen between a first end and a second end (whereas first coupler 2 is seen as the first end and second coupler 3 is seen as the second end, fig 1, and it defines the liquid channel 4 as the lumen, [0028]); and a cable port in a sidewall of the body between the first and second ends (see the electrical conductor port 7 found in between the first and second ends, fig 2); wherein a female electrode is within and protected by the cable port (wherein the electrical conductor is coupled to the inside of the catheter, [0012], and thereby functions as an electrode arranged internally) and positioned to contact fluid in the lumen (see [0011], in which the electric conductor connection allows for the performance of electrical measurements within the catheter and state of the liquid within the catheter); wherein the cable port is configured for removable connection to a housing at one end of the cable (wherein the electrical conductor cable via connection 7 is removably coupled to the connection device via a pin shaped catheter valve, [0012]), the housing having a male electrode within and protected by the housing (see in which the catheter connector is coupled via an electrically conductive pin shaped part, [0012], therefore equating to a male electrode via the pin shaped design).
Veldhuijzen does not explicitly teach wherein, when the housing is connected to the cable port, the male electrode contacts the female electrode; and wherein, when the housing is disconnected from the cable port, the female electrode remains within and protected by the cable port and the male electrode remains within and protected by the housing.
However, the analogous ECG catheter locating device taught by Pameijer does teach when the housing is connected to the cable port (see the device 78 seen as the housing, which is connected to the extension cable 66, [0102], see also fig 12), the male electrode contacts the female electrode (see in which the ECG electrode lead 72, which is part of the device 78 forms a snap connection via the electrode snap 70, [0102], therefore the snap connection naturally results in male and female electrodes); and wherein, when the housing is disconnected from the cable port, the female electrode remains within and protected by the cable port (see in which the snap connection disconnects and the electrode snap 70 remains in the cable 66, [0102]) and the male electrode remains within and protected by the housing (see in which the snap connection disconnects and the electrode snap 72 remains in the housing 78, [0102]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the catheter connector device of Veldhuijzen to have the fitting connections disclosed by Pameijer as they are simply another connection method to electrically connect and seal to fluid administration devices and catheters as disclosed by Pameijer, [0102].
Furthermore, Veldhuijzen nor Pameijer explicitly teach that the female electrode is arranged internally of the sidewall as well as the housing containing the male electrode being an insulative housing.
However, the analogous liquid circuit connection interface taught by Wiley does disclose that upon the cable port connection both that the female electrode is arranged internally of the sidewall (see in the fig 3, in which the electrode jack 26 seen as the analogous female electrode is found recessed within the insulating plastic sidewall portion 32, see also col 5, lines 1-5) as well as the housing containing the male electrode being an insulative housing (see from fig 3, in which the male input electrode unit is found within the patch cord housing 24, in which the cord housing 24 is a shielded insulating member, see also col 5, lines 1-5).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the body catheter adapter apparatus taught by Veldhuijzen and Pameijer to contain the specific insulated male electrode housing connection with the insulated female electrode sidewall connection as taught by Wiley, as it is another known method of making electrical connections which ensure proper insulation and conductivity when in use as taught by Wiley, [col 5, lines 1-5].
Regarding claim 13, Veldhuijzen teaches the adapter of claim 12, wherein the first end is configured to connect to a syringe and the second end is configured to connect to a catheter (wherein the first connector 2 is configured to removably couple the connector to the catheter and the second connector 3 is configured to removably couple the connector device 1 to a fluid administration apparatus shown as a syringe, [0027], see also fig 3).
Regarding claim 14, the combination teaches the adapter of claim 13, wherein the first and second ends comprise luer connectors (Pameijer discloses that the hub connector 58 may have a luer fitting for connecting to a catheter of syringe, [0099]).
Regarding claim 15, the combination teaches the adapter of claim 12, wherein the cable port and the insulative housing form a bayonet or luer lock connection when the insulative housing is connected to the cable port (Pameijer discloses that the hub connector 78 may have a luer fitting for connecting to a catheter, [0099].
Regarding claim 16, Veldhuijzen teaches a cable for use in an ECG-based catheter tip positioning system (catheter connector 1 which connects to an ECG cable, [0027]), the cable comprising: a housing at one end of the cable configured for removable connection to a cable port of an adapter (see connector device 10 which contains an electrical conductor portion 70 for plugging into a cable, wherein the connector device contains the housing, [0032]); a male electrode being within and protected by the housing (see in which the catheter connector is coupled via an electrically conductive pin shaped part, [0012], therefore equating to a male electrode via the pin shaped design); and a connector at an opposite end of the cable configured to connect the cable to ECG electronics of the ECG-based catheter tip positioning system (see in which the electrical conductor portion 70 which forms the cable is in connection with the ECG measuring device 120, [0032]); wherein the adapter has a body defining a lumen (whereas first coupler 2 is seen as the first end and second coupler 3 is seen as the second end, fig 1, and it defines the liquid channel 4 as the lumen, [0028]) and the cable port in a sidewall of the body (see the electrical conductor port 7 found in between the first and second ends, fig 2), a female electrode being within and protected by the cable port and positioned to contact fluid in the lumen (wherein the electrical conductor is coupled to the inside of the catheter, [0012], and thereby functions as the female electrode arranged internally).
Veldhuijzen does not explicitly teach wherein, when the housing is connected to the cable port, the male electrode contacts the female electrode; and wherein, when the housing is disconnected from the cable port, the female electrode remains within and protected by the cable port and the male electrode remains within and protected by the housing.
However, the analogous ECG catheter locating device taught by Pameijer does teach when the housing is connected to the cable port (see the device 78 seen as the housing, which is connected to the extension cable 66, [0102], see also fig 12), the male electrode contacts the female electrode (see in which the ECG electrode lead 72, which is part of the device 78 forms a snap connection via the electrode snap 70, [0102], therefore the snap connection naturally results in male and female electrodes); and wherein, when the housing is disconnected from the cable port, the female electrode remains within and protected by the cable port (see in which the snap connection disconnects and the electrode snap 70 remains in the cable 66, [0102]) and the male electrode remains within and protected by the housing (see in which the snap connection disconnects and the electrode snap 72 remains in the housing 78, [0102]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the catheter connector device of Veldhuijzen to have the fitting connections disclosed by Pameijer as they are simply another connection method to electrically connect and seal to fluid administration devices and catheters as disclosed by Pameijer, [0102].
Furthermore, Veldhuijzen nor Pameijer explicitly teach that the female electrode is arranged internally of the sidewall as well as the housing containing the male electrode being an insulative housing.
However, the analogous liquid circuit connection interface taught by Wiley does disclose that upon the cable port connection both that the female electrode is arranged internally of the sidewall (see in the fig 3, in which the electrode jack 26 seen as the analogous female electrode is found recessed within the insulating plastic sidewall portion 32, see also col 5, lines 1-5) as well as the housing containing the male electrode being an insulative housing (see from fig 3, in which the male input electrode unit is found within the patch cord housing 24, in which the cord housing 24 is a shielded insulating member, see also col 5, lines 1-5).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the body catheter adapter apparatus taught by Veldhuijzen and Pameijer to contain the specific insulated male electrode housing connection with the insulated female electrode sidewall connection as taught by Wiley, as it is another known method of making electrical connections which ensure proper insulation and conductivity when in use as taught by Wiley, [col 5, lines 1-5].
Regarding claim 18, the combination teaches the cable of claim 16, wherein the housing and the cable port form a bayonet or luer lock connection when the housing is connected to the cable port (Pameijer discloses that the hub connector 78 may have a luer fitting for connecting to a catheter, [0099]).
Regarding claim 20, Veldhuijzen teaches a kit for use with an ECG-based catheter tip positioning system (see [0003] – [0004], in which tip localization using ECG reading methodology is described), the kit comprising: an adapter for use with a catheter (catheter connector 1, [0027]) and a cable in an ECG-based catheter tip positioning system (catheter connector 1 which connects to an ECG cable, [0027]), the adapter comprising a body defining a lumen between a first end and a second end (whereas first coupler 2 is seen as the first end and second coupler 3 is seen as the second end, fig 1, and it defines the liquid channel 4 as the lumen, [0028]) and a cable port in a sidewall of the body between the first and second ends (see the electrical conductor port 7 found in between the first and second ends, fig 2), a female electrode being within and protected by the cable port and positioned to contact fluid in the lumen (wherein the electrical conductor is coupled to the inside of the catheter, [0012], and thereby functions as the female electrode arranged internally); and a cable for use with the adapter, the cable comprising a housing at one end of the cable configured for removable connection to the cable port of the adapter (see connector device 10 which contains an electrical conductor portion 70 for plugging into a cable, wherein the connector device contains the housing, [0032]), a male electrode being within and protected by the housing (see in which the catheter connector is coupled via an electrically conductive pin shaped part, [0012], therefore equating to a male electrode via the pin shaped design), and a connector at an opposite end of the cable configured to connect the cable to ECG electronics of the ECG-based catheter tip positioning system (see in which the electrical conductor portion 70 which forms the cable is in connection with the ECG measuring device 120, [0032]); to provide an electrical path between a tip of the catheter and ECG electronics of the ECG-based catheter tip positioning system for catheter tip positioning and subsequent tip migration checks (see [0004]-[0006], which discloses how tip localization and positioning features are present using real time ECG readings to determine where the tip is before and after placement).
Veldhuijzen does not explicitly teach wherein, when the housing is connected to the cable port, the male electrode contacts the female electrode; and wherein, when the housing is disconnected from the cable port, the female electrode remains within and protected by the cable port and the male electrode remains within and protected by the housing.
However, the analogous ECG catheter locating device taught by Pameijer does teach when the housing is connected to the cable port (see the device 78 seen as the housing, which is connected to the extension cable 66, [0102], see also fig 12), the male electrode contacts the female electrode (see in which the ECG electrode lead 72, which is part of the device 78 forms a snap connection via the electrode snap 70, [0102], therefore the snap connection naturally results in male and female electrodes); and wherein, when the housing is disconnected from the cable port, the female electrode remains within and protected by the cable port (see in which the snap connection disconnects and the electrode snap 70 remains in the cable 66, [0102]) and the male electrode remains within and protected by the housing (see in which the snap connection disconnects and the electrode snap 72 remains in the housing 78, [0102]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the catheter connector device of Veldhuijzen to have the fitting connections disclosed by Pameijer as they are simply another connection method to electrically connect and seal to fluid administration devices and catheters as disclosed by Pameijer, [0102].
Furthermore, Veldhuijzen nor Pameijer explicitly teach that the female electrode is arranged internally of the sidewall as well as the housing containing the male electrode being an insulative housing.
However, the analogous liquid circuit connection interface taught by Wiley does disclose that upon the cable port connection both that the female electrode is arranged internally of the sidewall (see in the fig 3, in which the electrode jack 26 seen as the analogous female electrode is found recessed within the insulating plastic sidewall portion 32, see also col 5, lines 1-5) as well as the housing containing the male electrode being an insulative housing (see from fig 3, in which the male input electrode unit is found within the patch cord housing 24, in which the cord housing 24 is a shielded insulating member, see also col 5, lines 1-5).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the body catheter adapter apparatus taught by Veldhuijzen and Pameijer to contain the specific insulated male electrode housing connection with the insulated female electrode sidewall connection as taught by Wiley, as it is another known method of making electrical connections which ensure proper insulation and conductivity when in use as taught by Wiley, [col 5, lines 1-5].
With regards to claim 21, the combination teaches the adapter of claim 12, wherein the body is made from an electrically insulative material (see in the Wiley fig 3, in which the electrode jack 26 seen as the analogous female electrode is found recessed within the insulating plastic sidewall portion 32, see also col 5, lines 1-5).
Response to Arguments
Applicants’ arguments with respect to amended claim(s) 12, 15-16, 20 as well as new claim 21 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.
Specifically, the examiner agrees with the applicant that the previous prior art of record containing Veldhuijzen and Pameijer does not teach the entirety of the newly amended claims alone. However, upon further search and consideration, necessitated by the newly amended claim limitations, it has been found that the new prior art of record rejection of Wiley does reasonably teach and disclose all of the new limitations presented within the claims. Regarding the new limitations presented relating to the male and female electrode connections and how they are configured in each component, it has been found that the new prior art of record Wiley does disclose that upon the cable port connection both that the female electrode is arranged internally of the sidewall (see in the fig 3, in which the electrode jack 26 seen as the analogous female electrode is found recessed within the insulating plastic sidewall portion 32, see also col 5, lines 1-5) as well as the housing containing the male electrode being an insulative housing (see from fig 3, in which the male input electrode unit is found within the patch cord housing 24, in which the cord housing 24 is a shielded insulating member, see also col 5, lines 1-5). Therefore, as all of the newly amended claim limitations are taught by the new prior art of record combination, the newly amended claims 12, 15-16, 20 as well as new claim 21 remain rejected under the new prior art of record rejection of Veldhuijzen in view of Pameijer further in view of Wiley set forth in the present office action.
As no further arguments or remarks have been presented in regard to the other claims, they too remain rejected based on their dependence on the newly rejected claims 12, 15-16, 20 set forth in the present office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
