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 .
Claim Objections
Claims 1, 8-10, 12-13, 20, 22-23, and 25 are objected to because of the following informalities:
Claim 1 is objected to for a typographical error wherein the claim recites “from the reservoir though the infusion catheter” and should instead recite “from the reservoir through the infusion catheter”.
Claims 1, 13, and 25 are objected to for typographical errors regarding improper antecedent basis where the claims recite “(a) insertion of the infusion catheter into a subcutaneous layer of the user” and should instead recite “(a) insertion of the infusion catheter into the subcutaneous layer of the user”.
Claims 8 and 20 are objected to for a typographical error wherein the claims recite “that is attached to section of the rigid tube” and should instead recite “that is attached to a section of the rigid tube”.
Claim 9 is objected to for a typographical error regarding improper antecedent basis where the claim recites “that is attached to the distal end of the rigid tube” and should instead recite “that is attached to the distal end of a rigid tube”.
Claim 10 is objected to for a typographical error wherein the claim recites “the sensor configured” and should instead recite “the sensor is configured”.
Claims 10 and 22 are objected to for typographical errors regarding improper antecedent basis where the claims recite “exposed to the interstitial fluid of the user” and should instead recite “exposed to interstitial fluid of the user”.
Claim 12 is objected to for a typographical error regarding improper antecedent basis where the claim recites “the active electrode being adjacent to the tip of the infusion catheter” and should instead recite “the active electrode being adjacent to a tip of the infusion catheter”.
Claims 13 and 25 are objected to for typographical errors regarding improper antecedent basis where the claims recite “for pumping the medicament from the reservoir into the subcutaneous layer of the user” and should instead recite “for pumping the medicament from the reservoir into a subcutaneous layer of the user”.
Claim 25 is objected to for a typographical error regarding improper antecedent basis where the claim recites “wherein the assembly is configured to be used with a device for delivering medicament to the user” and should instead recite “wherein the assembly is configured to be used with a device for delivering the medicament to the user”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 12-21, and 24-29 and is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Antwerp et al. (US 20090062767, henceforth Van Antwerp).
Regarding claim 1, Van Antwerp discloses a device (embodiment of [0051] with arrangement of fig. 7) for delivering medicament to a user (insulin as in [0008]), the device comprising: a reservoir (fluid reservoir as in [0051]) for storing medicament ([0051]); an infusion catheter (inner infusion tube of fig. 7) fluidly communicating with the reservoir (see [0051], the infusion tube is connected to the reservoir to allow the infusion tube to deliver the fluid to the user from the reservoir) to deliver the medicament into a subcutaneous layer of the user (see [0005] and [0006], infusion is subcutaneous); a pump (medication infusion pump of [0051]) fluidly communicating with the reservoir and infusion catheter (see [0051], the pump is connected as claimed to be configured to move fluid from the reservoir into the user as disclosed) for pumping the medicament from the reservoir through the infusion catheter ([0051]); an introducer needle (needle of fig. 7B) movable within the infusion catheter (see at least [0064]), the introducer needle configured to facilitate (a) insertion of the infusion catheter into a subcutaneous layer of the user ([0062]) and (b) retraction of the introducer needle after insertion of the infusion catheter ([0062]) to enable delivery of medicament through the infusion catheter ([0062] and [0063]); and a sensor (sensor of fig. 7C) for continuously monitoring glucose level in the user (see [0135]), wherein the sensor is configured to (a) engage the introducer needle and/or the infusion catheter (see fig. 7C, the structures are engaged where they are connected) and (b) simultaneously advance along with the infusion catheter during the insertion into the subcutaneous layer of the user by the introducer needle (see at least [0044], the piercing member which is the introducer needle is configured to facilitate insertion of the sensor, and thus the sensor is configured as claimed since all of the structures insert simultaneously).
Regarding claim 2, Van Antwerp discloses the device of claim 1 wherein the sensor and infusion catheter each have distal ends that are fixed relative to one another (see at least [0064], the sensor is between the walls of the inner and outer tube and thus the distal end of the sensor and of the inner tube are fixed, note that there is a typo in [0064] which states figs. 8A-8C instead of figs. 7A-7C).
Regarding claim 3, Van Antwerp discloses the device of claim 1 further comprising a catheter sheath (outer tube 250, fig. 7B) around the infusion catheter (see fig. 7), wherein the sensor is positioned between the infusion catheter and catheter sheath (see fig. 7C, the structures are radially and longitudinally arranged as claimed) thereby holding the sensor in place (see fig. 7C, the arrangement of structures holds the sensor in place as claimed).
Regarding claim 4, Van Antwerp discloses the device of claim 3 wherein the catheter sheath includes an opening (see fig. 7C, there is an opening which runs along the length of the outer sheath; this is called out as the sensor electrode window 195 in fig. 6B) to enable an active electrode of the sensor to access an interstitial fluid of the user after insertion (see [0027], [0051], and [0107], the window is to allow the sensor to contact the body, and the part of the body measured is interstitial fluid by way of an electrode).
Regarding claim 5, Van Antwerp discloses the device of claim 1 wherein the sensor extends along an exterior of the infusion catheter (see fig. 7C) for simultaneous insertion of the sensor and infusion catheter (see similar embodiment of fig. 4 in [0020], the needle is inserted with the assembly including the sensor and inner and outer catheters).
Regarding claim 6, Van Antwerp discloses the device of claim 1 wherein the sensor is attached to the introducer needle for simultaneous insertion with the infusion catheter (see similar embodiment of fig. 4 in [0020], the needle is inserted with the assembly including the sensor and inner and outer catheters), wherein the sensor is configured to detach from the introducer needle when the introducer needle is retracted (see [0020], the needle retracts while the other structures stay in place).
Regarding claim 7, Van Antwerp discloses the device of claim 1 further comprising a rigid tube (outer tube of fig. 7) positioned between the introducer needle and infusion catheter (see fig. 7, the outer tube is longitudinally between the distal tip of the needle and the proximal tip of the infusion catheter as shown).
Regarding claim 8, Van Antwerp discloses the device of claim 7 wherein the infusion catheter includes an opening (sensor electrode window shown in fig. 7 and called out in fig. 6F) exposing a section of the rigid tube to the interstitial fluid of the user (see fig. 7, the interior of the outer tube is exposed to the interstitial fluid of the user when the needle assembly is inserted due to the sensor electrode window shown), wherein the sensor extends along an exterior of the infusion catheter (see fig. 7) and includes a distal end (see fig. 7C, the distal end of the called out sensor is the end furthest from potting 270) that is attached to section of the rigid tube (see figs. 7B and 7C, the distal end of the sensor is attached to the outer tube including its distal end where it is located on the exterior of the infusion tube which is connected to the outer tube at least at potting 270).
Regarding claim 9, Van Antwerp discloses the device of claim 7 wherein the rigid tube extends from a distal end of the infusion catheter (see fig. 7C, the outer tube extends proximally from the distal end of the infusion catheter), wherein the sensor extends along an exterior of the infusion catheter (see fig. 7C) and includes a distal end (see fig. 7C, the distal end of the called out sensor is the end furthest from potting 270) that is attached to the distal end of the rigid tube (see figs. 7B and 7C, the distal end of the sensor is attached to the outer tube including its distal end where it is located on the exterior of the infusion tube which is connected to the outer tube at least at potting 270).
Regarding claim 12, Van Antwerp discloses the device of claim 9 wherein the sensor includes an active electrode (see [0030], the sensor has a working electrode which is an active electrode as claimed) and reference electrode (see [0030], the sensor has a reference electrode), the active electrode being adjacent to the tip of the infusion catheter (see fig. 7, the working electrode is a part of the called out sensor and is next to, or adjacent to, the distal most tip of the infusion catheter).
{Examiner notes that the additional claim language of claim 12 is optional and not required.}
Regarding claim 13, Van Antwerp discloses a device (embodiment of [0051] with arrangement of fig. 7) for delivering medicament to a user (insulin as in [0008]), the device including a reservoir (fluid reservoir as in [0051]) for storing medicament ([0051]), a pump (medication infusion pump of [0051]) fluidly communicating with the reservoir for pumping the medicament from the reservoir into the subcutaneous layer of the user (see [0051], the pump is connected as claimed to be configured to move fluid from the reservoir into the user as disclosed) and an assembly for continuously monitoring glucose level in the user (arrangement of fig. 7) and for delivering the medicament to the user based on the monitored glucose level (see [0051] and [0108]), the assembly comprising: an infusion catheter (inner infusion tube of fig. 7) fluidly communicating with the pump to deliver the medicament into the subcutaneous layer of the user (see [0051], the infusion tube is connected to the pump and to the reservoir to allow the infusion tube to deliver the fluid to the user from the reservoir); an introducer needle (needle of fig. 7B) movable within the infusion catheter (see at least [0064]), the introducer needle configured to facilitate (a) insertion of the infusion catheter into a subcutaneous layer of the user (see at least [0062]) and (b) retraction of the introducer needle after insertion of the infusion catheter to enable delivery of medicament through the infusion catheter (see at least [0062] and [0063]); and a sensor (sensor of fig. 7C) for continuously monitoring glucose level in the user (see [0135], wherein the sensor is configured to (a) engage the introducer needle and/or the infusion catheter (see fig. 7C, the structures are engaged where they are connected) and (b) simultaneously advance along with the infusion catheter during the insertion into the subcutaneous layer of the user by the introducer needle (see at least [0044], the piercing member which is the introducer needle is configured to facilitate insertion of the sensor, and thus the sensor is configured as claimed since all of the structures insert simultaneously).
Regarding claim 14, Van Antwerp discloses the device of claim 13 wherein the sensor and infusion catheter each have distal ends that are fixed relative to one another (see at least [0064], the sensor is between the walls of the inner and outer tube and thus the distal end of the sensor and of the inner tube are fixed, note that there is a typo in [0064] which states figs. 8A-8C instead of figs. 7A-7C).
Regarding claim 15, Van Antwerp discloses the device of claim 13 wherein the assembly further comprising a catheter sheath (outer tube 250, fig. 7B) around the infusion catheter (see fig. 7), wherein the sensor is positioned between the infusion catheter and catheter sheath (see fig. 7C, the structures are radially and longitudinally arranged as claimed) thereby holding the sensor in place (see fig. 7C, the arrangement of structures holds the sensor in place as claimed).
Regarding claim 16, Van Antwerp discloses the device of claim 15 wherein the catheter sheath includes an opening (see fig. 7C, there is an opening which runs along the length of the outer sheath; this is called out as the sensor electrode window 195 in fig. 6B) to enable an active electrode of the sensor to access an interstitial fluid of the user after insertion (see [0027], [0051], and [0107], the window is to allow the sensor to contact the body, and the part of the body measured is interstitial fluid by way of an electrode).
Regarding claim 17, Van Antwerp discloses the device of claim 13 wherein the sensor extends along an exterior of the infusion catheter (see fig. 7C) for simultaneous insertion of the sensor and infusion catheter (see similar embodiment of fig. 4 in [0020], the needle is inserted with the assembly including the sensor and inner and outer catheters).
Regarding claim 18, Van Antwerp discloses the device of claim 13 wherein the sensor is attached to the introducer needle for simultaneous insertion with the infusion catheter (see similar embodiment of fig. 4 in [0020], the needle is inserted with the assembly including the sensor and inner and outer catheters), wherein the sensor is configured to detach from the introducer needle when the introducer needle is retracted (see [0020], the needle retracts while the other structures stay in place).
Regarding claim 19, Van Antwerp discloses the device of claim 13 wherein the assembly further comprising a rigid tube (outer tube of fig. 7) positioned between the introducer needle and infusion catheter (see fig. 7, the outer tube is longitudinally between the distal tip of the needle and the proximal tip of the infusion catheter as shown).
Regarding claim 20, Van Antwerp discloses the device of claim 19 wherein the infusion catheter includes an opening (sensor electrode window shown in fig. 7 and called out in fig. 6F) exposing a section of the rigid tube to the interstitial fluid of the user (see fig. 7, the interior of the outer tube is exposed to the interstitial fluid of the user when the needle assembly is inserted due to the sensor electrode window shown), wherein the sensor extends along an exterior of the infusion catheter (see fig. 7) and includes a distal end (see fig. 7C, the distal end of the called out sensor is the end furthest from potting 270) that is attached to section of the rigid tube (see figs. 7B and 7C, the distal end of the sensor is attached to the outer tube including its distal end where it is located on the exterior of the infusion tube which is connected to the outer tube at least at potting 270).
Regarding claim 21, Van Antwerp discloses the device of claim 19 wherein the rigid tube extends from a distal end of the infusion catheter (see fig. 7C, the outer tube extends proximally from the distal end of the infusion catheter), wherein the sensor extends along an exterior of the infusion catheter (see fig. 7C) and includes a distal end (see fig. 7C, the distal end of the called out sensor is the end furthest from potting 270) that is attached to the distal end of the rigid tube (see figs. 7B and 7C, the distal end of the sensor is attached to the outer tube including its distal end where it is located on the exterior of the infusion tube which is connected to the outer tube at least at potting 270).
Regarding claim 24, Van Antwerp discloses the device of claim 21 wherein the sensor includes an active electrode (see [0030], the sensor has a working electrode which is an active electrode as claimed) and reference electrode (see [0030], the sensor has a reference electrode), the active electrode being adjacent to the tip of the infusion catheter (see fig. 7, the working electrode is a part of the called out sensor and is next to, or adjacent to, the distal most tip of the infusion catheter).
Regarding claim 29, Van Antwerp discloses the device of claim 21 wherein the sensor extends along an exterior of the infusion catheter (see fig. 7C) for simultaneous insertion of the sensor and infusion catheter (see similar embodiment of fig. 4 in [0020], the needle is simultaneously inserted with the assembly including the sensor and inner infusion and outer catheters).
Regarding claim 25, Van Antwerp discloses an assembly for continuously monitoring glucose level in a user (see [0108], glucose concentration in the body of a user is monitored) and for delivering medicament to the user (insulin as in [0008]) based on the monitored glucose level (see [0108], the calculated dose is determined by the monitored glucose concentration), wherein the assembly is configured to be used with a device (embodiment of [0051] with arrangement of fig. 7) for delivering medicament to the user (insulin as in [0008]), the device including a reservoir (fluid reservoir as in [0051]) for storing medicament ([0051]), a pump (medication infusion pump of [0051]) fluidly communicating with the reservoir for pumping the medicament from the reservoir into the subcutaneous layer of the user (see [0051], the pump is connected as claimed to be configured to move fluid from the reservoir into the user as disclosed) and an assembly (arrangement of fig. 7) for continuously monitoring glucose level in the user (see at least [0038]) and for delivering the medicament to the user based on the monitored glucose level (see [0051] and [0108]), the assembly comprising: an infusion catheter (inner infusion tube of fig. 7) fluidly communicating with the pump to deliver the medicament into the subcutaneous layer of the user (see [0051], the infusion tube is connected to the pump and the reservoir to allow the infusion tube to deliver the pumped fluid to the user from the reservoir); an introducer needle (needle of fig. 7B) movable within the infusion catheter (see at least [0064]), the introducer needle configured to facilitate (a) insertion of the infusion catheter into a subcutaneous layer of the user ([0062]) and (b) retraction of the introducer needle after insertion of the infusion catheter ([0062]) to enable delivery of medicament through the infusion catheter ([0062] and [0063]); and a sensor (sensor of fig. 7C) for continuously monitoring glucose level in the user (see [0135]), wherein the sensor is configured to (a) engage the introducer needle and/or the infusion catheter (see fig. 7C, the structures are engaged where they are connected) and (b) simultaneously advance along with the infusion catheter during the insertion into the subcutaneous layer of the user by the introducer needle (see at least [0044], the piercing member which is the introducer needle is configured to facilitate insertion of the sensor, and thus the sensor is configured as claimed since all of the structures insert simultaneously).
Regarding claim 26, Van Antwerp discloses the assembly of claim 25 wherein the sensor and infusion catheter each have distal ends that are fixed relative to one another (see at least [0064], the sensor is between the walls of the inner and outer tube and thus the distal end of the sensor and of the inner tube are fixed, note that there is a typo in [0064] which states figs. 8A-8C instead of figs. 7A-7C).
Regarding claim 27, Van Antwerp discloses the assembly of claim 25 wherein the assembly further comprising a catheter sheath (outer tube 250, fig. 7B) around the infusion catheter (see fig. 7), wherein the sensor is positioned between the infusion catheter and catheter sheath (see fig. 7C, the structures are radially and longitudinally arranged as claimed) thereby holding the sensor in place (see fig. 7C, the arrangement of structures holds the sensor in place as claimed).
Regarding claim 28, Van Antwerp discloses the assembly of claim 27 wherein the catheter sheath includes an opening (see fig. 7C, there is an opening which runs along the length of the outer sheath; this is called out as the sensor electrode window 195 in fig. 6B) to enable an active electrode of the sensor to access an interstitial fluid of the user after insertion (see [0027], [0051], and [0107], the window is to allow the sensor to contact the body, and the part of the body measured is interstitial fluid by way of an electrode).
Claim Rejections - 35 USC § 103
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.
Claim(s) 10 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Antwerp et al. (US 20090062767, henceforth Van Antwerp, made of record in the IDS filed 04/02/2024) as applied to claims 1 and 19 above, respectively, and further in view of Schwind et al. (US 20100113907, henceforth Schwind, made of record in the IDS filed 04/02/2024).
Regarding claims 10 and 22, Van Antwerp discloses the device of claims 1 and 19, respectively, wherein the sensor is configured to extend around an exterior of the infusion catheter (see fig. 7C, the sensor is shown extending partially around the circumference of the inner infusion tube within the sensor window of the outer tube) and wherein the sensor includes an active electrode (see [0030], the sensor has a working electrode which is an active electrode as claimed) exposed to the interstitial fluid of the user (see at least [0027] and [0107]-[0108]), thereby enabling sensing (see at least [0027] and [0107]-[0108]).
Van Antwerp does not disclose the device wherein the sensor is configured to loop around a heal of the introducer needle as claimed. Schwind teaches a sensor (tubular sensor 122, fig. 1) configured to loop around a heal of an introducer needle (see fig. 1, electrode rings 126 loop completely around all aspects of needle 118).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the electrodes of the sensor to loop around the entire infusion catheter of Van Antwerp as in following the shape of Schwind as Schwind teaches such a configuration to be easier and more cost effective to produce, as well as more accurate (see Schwind [0008] and [0014]). Thus, in the modified device, the sensor would be configured to loop around a heal of the introducer needle as claimed where the sensor is mounted circumferentially around the infusion catheter which the introducer needle is retractably positioned inside of, and thus the sensors are configured to loop around the needle within the catheter.
Claim(s) 11 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Antwerp et al. (US 20090062767, henceforth Van Antwerp, made of record in the IDS filed 04/02/2024) as applied to claims 1 and 19 above.
Regarding claims 11 and 23, Van Antwerp discloses the device of claims 1 and 13, respectively.
Van Antwerp additionally teaches an alternative embodiment wherein the sensor extends through a lumen of the introducer needle (see embodiment of fig. 8B, the sensor is shown extending through a hollow introducer needle lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the sensor to have extended through a lumen of the introducer needle as in the alternative embodiment taught by Van Antwerp as Van Antwerp teaches the arrangements to be art effective equivalents (see at least [0023], [0024], and [0057]), where making such a modification would have yielded the same, predictable result of the sensor measuring interstitial fluid blood glucose levels ([0057]), and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
In the modified device of Van Antwerp, the sensor is considered to loop around a heal of the introducer needle as claimed where the distal end of the bent portion of the sensor which is shown in fig. 8C is configured to bend, or loop, near to, or around, a heal of the introducer needle when the introducer needle is retracted after insertion and the heal of the introducer needle which is its beveled distal tip passes over the bent portion of the sensor, similar to the state shown in fig. 8C.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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