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
Claim(s) 1, 6, 7, 8 and 10 is/are objected due to the following informalities:
In claim 1, line 5, “connection tubing” should be corrected to “a connection tubing” for grammatical correctness.
In claim 6, line 2, “at least a portion of the adhesive pad” should be corrected to “at least a portion of the at least one adhesive pad” for claim language consistency.
In claim 7, line 2, “the adhesive pad” should be corrected to “the at least one adhesive pad” for claim language consistency.
In claim 8, line 2, “the adhesive pad” should be corrected to “the at least one adhesive pad” for claim language consistency.
In claim 10, line 2. “extension tubing” should be corrected to “an extension tubing” for grammatical correctness.
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, 2, 3, 4, 5, 7, 11, 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 20140088555 A1, herein Li).
Regarding claim 1, Li discloses a drug delivery investigation device (drug pump device 500 in Fig. 5A; monitor the pump pressure and/or the flow rate during drug delivery [0041]) comprising:
a needle insertion mechanism (rigid hollow needle 502 in Fig. 5A) comprising a cannula (soft cannula 504 in Fig. 5A);
a flow path (fluid path connector 526 in Fig. 5C) comprising an inlet (see inlet in annotated Fig. 5C below) configured to be in fluid communication with a fluid source (drug vial 506 in Fig. 5C; inlet is in fluid communication with vial 506 in annotated Fig. 5C below) and an outlet (see outlet in annotated Fig. 5C below);
connection tubing (flexible tubing 524 in Fig. 5C) extending between the outlet of the flow path and the needle insertion mechanism (flexible tubing 524 is located between outlet of fluid path connector 526 in annotated Fig. 5C), the connection tubing in fluid communication with the cannula and the flow path (it can be interpreted that the flexible tubing 524 establishes a fluid communication between cannula 504 and fluid path connector 526 since drug is delivered from vial to patient via needle 502 and cannula 504 according to Fig. 5C);
a flow sensor positioned between the inlet and the outlet of the flow path (one or more flow sensors 318 and/or pressure sensors in the drug reservoir and/or the cannula or other fluid-path component 319 downstream of the reservoir in system 300 [0044]; other fluid path component 319 can be interpreted as fluid path connector 526 and therefore it can be interpreted that flow sensor 318 is located in fluid path connector 526; it is also set forth in [0042] that system 300 is a control system for drug pump control 500); and
a pressure sensor positioned between the inlet and the outlet of the flow path (one or more flow sensors 318 and/or pressure sensors in the drug reservoir and/or the cannula or other fluid-path component 319 downstream of the reservoir in system 300 [0044]; it can be interpreted that pressure sensor 316 or similar is located in fluid path connector 526 similar to flow sensor 318).
PNG
media_image1.png
283
657
media_image1.png
Greyscale
Annotated Fig. 5C of Li
Regarding claim 2, Li disclosed all limitations of claim 1. Li further discloses wherein the pressure sensor is positioned between the outlet of the flow path and the flow sensor (one or more flow sensors 318 and/or pressure sensors in the drug reservoir and/or the cannula or other fluid-path component 319 downstream of the reservoir in system 300 [0044]; it is interpreted that the location of the pressure sensor is between the flow sensor and outlet of the fluid-path connector 526 since it is set forth in [0044] that flow sensor and/or pressure sensor is located in other fluid-path component downstream of the reservoir).
Regarding claim 3, Li disclosed all limitations of claim 1. Li further discloses wherein the flow sensor comprises an inline flow sensor (one or more flow sensors 318 and/or pressure sensors in the drug reservoir and/or the cannula or other fluid-path component 319 downstream of the reservoir in system 300 [0044]; since it is set forth that the flow sensor is located in fluid path connector 526, it can be interpreted that the drug flows through the sensor and therefore the flow sensor is inline).
Regarding claim 4, Li disclosed all limitations of claim 1. Li further discloses further comprising a base (bottom wall 506 in Fig. 5A), wherein the needle insertion mechanism, the flow path, the flow sensor, and the pressure sensor are supported by the base (needle 502 is supported by bottom wall 508 seen in Fig. 5A; it is also set forth in [0065] that the fluid path connector 526 is a part secured to vial 506 which is supported by bottom wall 508 in Fig. 5A and therefore it can be interpreted that the flow sensor and pressure sensor which was previously set forth as being located in the fluid path connector 526 is also supported by bottom wall 508).
Regarding claim 5, Li disclosed all limitations of claim 4. Li further discloses further comprising at least one adhesive pad attached to the base (device 500 is attached to the skin with an adhesive patch 512 placed between the bottom surface 508 and the skin [0063]).
Regarding claim 7, Li disclosed all limitations of claim 5. Li further discloses wherein the cannula is configured to extend through the adhesive pad (upon advancement of the injection needle 502 and cannula 504, deflects the needle 502 and cannula 504 from their horizontal axis and guides them downward at a pre-determined angle toward an opening 544 in the bottom wall 508 of the device housing (if an adhesive patch is used, is generally aligned with an opening in the patch) [0069]).
Regarding claim 11, Li disclosed all limitations of claim 1. Li further discloses wherein the needle insertion mechanism comprises a guide (opening 544 in annotated Fig. 6A) and a needle holder (needle guide 542 in Fig. 6A), the needle holder configured to be received within the guide (needle guide 542 can be seen inserted into opening 544 in annotated Fig. 6A) and moveable relative to the guide (the needle guide 542 is formed integrally with the housing or a part thereof or provided as a separate component secured to the housing [0069]; it can be interpreted that the needle guide 542 is moveable relative to the opening 544 since it is secured to the housing and not the base where the opening 544 is located).
Regarding claim 15, Li disclosed all limitations of claim 1. Li further discloses further comprising at least one processor (system controller 306 in Fig. 3) and at least one memory storage device (system memory 308 in Fig. 3), the at least one processor configured to store data from the flow sensor and the pressure sensor to the at least one memory storage device (sensor feedback is processed by dedicated sensor circuitry 322 and/or by the system controller 306 [0045]; system memory 308 stores a drug-delivery protocol in the form of instructions executable by the controller 306, which is loaded into the memory [0043]; it can be interpreted system controller 306 loads sensor feedback information on system memory 308).
Regarding claim 16, Li disclosed all limitations of claim 1. Li further discloses wherein the at least one memory storage device is configured to be connected to an external device (system memory 308 stores a drug-delivery protocol in the form of instructions executable by the controller 306, which is loaded into the memory at the time of manufacturing, or at a later time by data transfer from a flash drive [0043]; it is interpreted that system memory 308 is configured to be in connection with an external device such as flash drive).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20140088555 A1, herein Li), and further in view of Neta et al. (US 20160074577 A1, herein Neta).
Regarding claim 6, Li disclosed all limitations of claim 5. However, Li failed to explicitly disclose wherein at least a portion of the adhesive pad is configured to be moveable relative to the base, and wherein the at least one adhesive pad comprises a connection member configured to be connected to the base and an adhesive member attached to the connection member at one or more discrete locations to allow a portion of the adhesive member to move relative to the connection member.
However, Neta teaches the skin securable drug dispensing unit 10 connected to a skin adherable cradle 20 in Fig. 2a that can be adhered to skin with an adhesive 5. The drug dispensing unit 10 is disconnected from and reconnected to a cradle unit 20 [0127]. One of ordinary skill in the art teaches that the adhesive 5 of Neta is moveable relative to the base unit 10 since unit 10 is detachably connected to cradle 20, therefore cradle 20 of Neta is configured to work with the bottom wall 506 of Li. One of ordinary skill in the art also teaches that a portion of the adhesive 5 is configured to move relative to cradle 20 since cradle 20 partially covers the adhesive 5 as seen in Fig. 2a.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li to include at least a portion of the adhesive pad is configured to be moveable relative to the base, and wherein the at least one adhesive pad comprises a connection member configured to be connected to the base and an adhesive member attached to the connection member at one or more discrete locations to allow a portion of the adhesive member to move relative to the connection member as taught by Neta since such a modification enables the device of Li to move without causing disruption to the adhesive.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20140088555 A1, herein Li), and further in view of Shor et al. (US 20190009019 A1, herein Shor).
Regarding claim 8, Li disclosed all limitations of claim 5. Li however failed to explicitly disclose wherein the adhesive pad comprises a first disc-shaped pad and a second disc-shaped pad spaced from the first disc-shaped pad.
However, Shor teaches a pattern of three adhesive 183 spots, which in some instances is the minimum number of spots that will fix the device in a given plane and prevent undesirable rotations [0172]. The disc shaped spots are spaced from each other as seen in Fig. 18A. One of ordinary skill in the art teaches the spots 183 of Shor to be incorporated into the adhesive pad of Li to act as disc shaped pads as required by claim 8.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li to include wherein the adhesive pad comprises a first disc-shaped pad and a second disc-shaped pad spaced from the first disc-shaped pad as taught by Shor since such a modification enables the device of Li to have fixation points to prevent undesirable rotations [Shor, 0172].
Claim(s) 9, 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20140088555 A1, herein Li), and further in view of Smith et al. (US 20230149623 A1, herein Smith).
Regarding claim 9, Li disclosed all limitations of claim 1. Li however failed to explicitly disclose further comprising a manifold, the manifold defining the outlet of the flow path, the manifold receiving the pressure sensor.
However, Smith teaches manifold 108 illustrated in FIGS. 3 and 4 has a body portion 114 that defines a through-bore 116 and the front wall 117 of the cartridge. The through-bore 116 is directly connected to a relatively short reservoir outlet port 118 [0232]. One of ordinary skill in the art teaches a manifold capable of being connected to an outlet port of a reservoir is to be configured to connect with the outlet of the fluid-path connector 526 of Li.
Smith further teaches a pressure sensor housing 122, which is integral with or otherwise connected to or carried by the manifold 108 [0235]. One of ordinary skill in the art teaches the pressure sensor of Li to be configured to connect with the manifold of Smith.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li to include further comprising a manifold, the manifold defining the outlet of the flow path, the manifold receiving the pressure sensor as taught by Smith since such a modification enables tight connection between the pressure sensor and flow path via the manifold.
Regarding claim 10, Li as modified by Smith disclosed all limitations of claim 9. However, Li disclosed that the connection tubing 524 is formed of a low mechanical compliance material (flexible tubing 524 made of, e.g., of parylene, phthalate-free (in particular, Di(2-ethylhexyl)phthalate-(DEHP)-free) PVC, ethylene-vinyl acetate (EVA), low-density polyethylene (LDPE), polyurethane, tygone, silicone, or another soft polymer [0065]) but failed to explicitly disclose wherein extension tubing extends between the manifold and the flow sensor, wherein the flow path is defined by the flow sensor, the extension tubing, and the manifold, and wherein the extension tubing is formed from a low mechanical compliance material.
However, Smith teaches the through-bore 116 and outlet port 118 of manifold 108 facilitate a direct fluidic connection between the cartridge 100 and the aforementioned cannulas and baseplates that have a portion thereof inserted into the through-bore [0232]. One of ordinary skill in the art teaches that the cannula in connection with through-bore 116 of manifold 108 is to be configured to work as an extension tubing to connect with the flow sensor of Li, and the cannula of Smith is also to be configured to be formed of similar material as flexible tubing 524 of Li.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li to include wherein extension tubing extends between the manifold and the flow sensor, wherein the flow path is defined by the flow sensor, the extension tubing, and the manifold, and wherein the extension tubing is formed from a low mechanical compliance material as taught by Smith since such a modification enables the device of Li to have tight connection between the flow sensor and flow path via the manifold.
Regarding claim 17, Li disclosed all limitations of claim 1. However, Li failed to explicitly disclose further comprising at least one ancillary sensor, the at least one ancillary sensor comprising at least one of an accelerometer, a photoplethysmography sensor, an ultrasonic scanner, a strain gage configured to capture skin deformation, a temperature sensor, and an impedance sensor.
However Smith teaches a temperature sensor 239 (e.g., a thermistor or thermocouple) to be carried within the pump assembly housing 202 in such a manner that the temperature sensor can sense the temperature of the medicament in the cartridge 100. The temperature sensor 239 to be carried on the circuit board associated with the exemplary controller 240 or on the chassis 244 [0360]. One of ordinary skill in the art teaches that the temperature sensor of 239 is to be configured to be used in conjunction with the device of Li.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li further comprising at least one ancillary sensor, the at least one ancillary sensor comprising at least one of an accelerometer, a photoplethysmography sensor, an ultrasonic scanner, a strain gage configured to capture skin deformation, a temperature sensor, and an impedance sensor as taught by Smith since a modification enables the device of Li to take temperature measurements of the fluid in the fluid source during delivery.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20140088555 A1, herein Li), and further in view of Pirbodaghi et al. (US 20240100247 A1, herein Pirbodaghi).
Regarding claim 12, Li disclosed all limitations of claim 11. However Li failed to explicitly disclose wherein the guide comprises a plurality of resilient arms defining an interior space configured to receive the needle holder, the plurality of resilient arms each comprising a cam surface configured to engage an engagement surface of the needle holder, and wherein the needle holder has a first position where the engagement surface is engaged with the cam surface and a second position where the engagement surface is within the interior space and spaced from the cam surface of the guide, the plurality of resilient arms configured to deflect radially outward when the needle holder moves from the first position to the second position.
However, Pirbodaghi teaches a latching member 12d located on the bottom wall 12b of the housing 12 engages a portion of the cannula yoke 120 to retain and prevent the cannula yoke 120 from moving in an axial direction [0151]. One of ordinary skill in the art teaches that the needle guide 544 of Li is to be configured to have latching member 12d as taught by Pirbodaghi near it and the needle holder 542 of Li is to be configured to have an engagement portion similar to the cannula yoke of Pirbodaghi in order to establish a detachable engagement between the needle guide and needle holder of Li.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li to include wherein the guide comprises a plurality of resilient arms defining an interior space configured to receive the needle holder, the plurality of resilient arms each comprising a cam surface configured to engage an engagement surface of the needle holder, and wherein the needle holder has a first position where the engagement surface is engaged with the cam surface and a second position where the engagement surface is within the interior space and spaced from the cam surface of the guide, the plurality of resilient arms configured to deflect radially outward when the needle holder moves from the first position to the second position as taught by Pirbodaghi since such a modification enables the device of Li to establish secured engagement between the needle holder and needle guide during delivery.
Regarding claim 13, Li as modified by Pirbodaghi disclosed all limitations of claim 12. However Li failed to explicitly disclose wherein the needle holder is configured to move from the first position to the second position upon application of a predetermined axial force to the needle holder.
However Pirbodaghi teaches the second end 120b of the cannula yoke 120 is dimensioned to be inserted into the opening 40, and as illustrated in FIG. 7, a latching member 12d located on the bottom wall 12b of the housing 12 engages a portion of the cannula yoke 120 to retain and prevent the cannula yoke 120 from moving in an axial direction [0151]. One of ordinary skill in the art teaches that the cannula yoke of Pirbodaghi is axially pushed by means of a force into the opening 40 from a first position to a second position wherein the cannula yoke engages with the opening 40 of Pirbodaghi, and therefore the needle holder of Li is to be configured to operate in this manner as taught by Pirbodaghi.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li to include wherein the needle holder is configured to move from the first position to the second position upon application of a predetermined axial force to the needle holder as taught by Pirbodaghi since such a modification enables the device of Li to establish secured engagement between the needle holder and needle guide during delivery.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20140088555 A1, herein Li), and further in view of Pirbodaghi et al. (US 20240100247 A1, herein Pirbodaghi) and Teoh et al. (US 20160361519 A1, herein Teoh).
Regarding claim 14, Li as modified by Pirbodaghi disclosed all limitations of claim 13. However LI as modified by Pirbodaghi failed to explicit disclose wherein the needle holder comprises a first luer connector attached to the cannula, a second luer connecter connected to the first luer connector and in fluid communication with the connection tubing, and an actuator body configured to be manually engaged and defining the engagement surface.
However, Teoh teaches the catheter hub 104 of Fig. 4 has a catheter tube 102 extending distally therefrom. At its proximal end 402, the catheter hub 104 connects to a flexible extension tube or flexible tube 404, which in turn is connected to a fluid port 406, which has a body with an opening having a Luer taper. The catheter hub 104 of the present embodiment has a generally flattened rectangular cuboid shape having grips 408a and 408b formed laterally of a central portion 412 [0061]. One of ordinary skill in the art teaches that the device of Li is to be configured to have a hub similar to the hub 104 of Teoh to have the cannula 504 attached to it as taught by Teoh, and the connection tubing 524 of Li is to be configured to be connected to the Luer port 406 of Teoh. One of ordinary skill in the art also teaches that the grips 408a and 408b of Teoh functions as engagement surfaces as required by claim 14.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the drug delivery investigation device of Li as modified by Pirbodaghi to include wherein the needle holder comprises a first luer connector attached to the cannula, a second luer connecter connected to the first luer connector and in fluid communication with the connection tubing, and an actuator body configured to be manually engaged and defining the engagement surface since such a modification enables the device of Li as modified by Pirbodaghi to establish a detachable connection between the cannula and connecting tubing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20200316292 A1 (Isaacson et al.) related to an occlusion detection device with a flow sensor and a pressure sensor.
US 20220387710 A1 (Malloy et al.) related to a drug delivery device with pressure sensor.
US 20220409051 A1 (Smeys et al.) related to a medication delivery device with flow sensor and pressure sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. 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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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.
/M.F./Patent Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights