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 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) 1-8, 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Just (US. 20210308368A1) in view of Carmel (US. 20020177808A1)
Re Claim 1, Just discloses a drug delivery device (abstract, Fig. 1a- 7, ¶0038), including a delivery unit (2, Fig, 1b) comprising a subcutaneous delivery system (¶0040) including a needle support (needle holder 12, Fig. 1b), an injection needle mounted on the needle support (needle 10 is coupled to 12, ¶0042) and an injection needle actuation mechanism (Fig. 6a-6b including 34,36, 38, 46a-b) configured to engage and slidably move the needle support from a retracted position (Fig. 6a) where the injection needle is within a housing of the drug delivery device (housing 4, Fig. 6a, ¶0058) to an extended delivery position (Fig. 6b, ¶0058) where the injection needle projects through a skin contact wall of the housing (¶0039, lower surface with adhesive base 9, Fig. 1a, Fig. 6b), but it fails to disclose that the delivery unit further comprises a needle shield mechanism comprising a needle shield cover slidably movable from a retracted position within the housing to an extended position covering the needle and a spring biasing the needle shield cover towards the extended position, the needle support comprising a shoulder engaging a shoulder of the needle shield cover configured to hold the needle shield cover in the retracted position prior to actuation of the injection needle actuation mechanism.
However, Carmel discloses a drug delivery device (Fig, 1-15) and wherein the device comprises a needle shield mechanism (38, 128, 130) comprising a needle shield cover (38, 128, 130) slidably movable from a retracted position (Fig. 9) within the housing (within the housing 52) to an extended position covering the needle (Fig. 15) and a spring (40, ¶0073) biasing the needle shield cover towards the extended position (¶0073), the needle support (30) comprising a shoulder (front end of 36) engaging a shoulder of the needle shield cover (abut lower end of 128. Fig. 9) capable to hold the needle shield cover in the retracted position (Fig. 9) prior to actuation of the injection needle actuation mechanism (20, 176, Fig. 14).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a needle shield mechanism so that the delivery unit further comprises a needle shield mechanism comprising a needle shield cover slidably movable from a retracted position within the housing to an extended position covering the needle and a spring biasing the needle shield cover towards the extended position, the needle support comprising a shoulder engaging a shoulder of the needle shield cover configured to hold the needle shield cover in the retracted position prior to actuation of the injection needle actuation mechanism as taught by Carmel for the purpose of preventing unwanted contact with the sharp needle (Carmel, ¶0072).
Re Claim 2, Just discloses wherein the needle support comprises a retracted position holder (18a-18b) releasably holding the needle support and needle shield mechanism in the retracted position prior to actuation of the injection needle actuation mechanism (Fig. 2a, 4a, ¶0062).
Re Claim 3, Just discloses wherein the retracted position holder comprises a clasp having at least one elastic arm releasable under an actuation force applied by the injection needle actuation mechanism (Fig. 2a, clasp by 44).
Re Claim 4, Just discloses wherein the retracted position holder comprises a pin engaged by the clasp in the retracted position, the pin extending from the needle support (clasp by pin 44).
Re Claim 5, Just fails to disclose wherein the needle shield cover is slidably mounted in a needle shield guide comprising a shield receiving cavity, the needle shield guide integrally formed or rigidly fixed to the housing or a housing part of the drug delivery device.
However, Carmel discloses a drug delivery device (Fig, 1-15) and wherein the device comprises a needle shield mechanism (38, 128, 130) is slidably mounted in a needle shield guide (180, 65, side close to 188) comprising a shield receiving cavity ( cavity within the 34, Fig.14), the needle shield guide integrally formed or rigidly fixed to the housing or a housing part of the drug delivery device (Fig. 14).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a needle shield guide so that the needle shield cover is slidably mounted in a needle shield guide comprising a shield receiving cavity, the needle shield guide integrally formed or rigidly fixed to the housing or a housing part of the drug delivery device as taught by Carmel for the purpose of guiding the shield for preventing unwanted contact with the sharp needle (Carmel, ¶0072).
Re Claim 6, Just fails to disclose the needle shield mechanism comprises a skin contact wall configured to protrude slightly beyond a skin contact wall of a housing of the drug delivery device during drug delivery.
However, Carmel discloses a drug delivery device (Fig, 1-15) and wherein the device comprises a needle shield mechanism (38, 128, 130) comprises a skin contact wall (131) configured to protrude slightly beyond a skin contact wall of a housing of the drug delivery device during drug delivery (top end of 52, Fig. 15).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a needle shield guide so that the needle shield mechanism comprises a skin contact wall configured to protrude slightly beyond a skin contact wall of a housing of the drug delivery device during drug delivery as taught by Carmel for the purpose of guiding the shield for preventing unwanted contact with the sharp needle (Carmel, ¶0072).
Re Claim 7, Just fails to disclose wherein the needle shield mechanism comprises a skin contact wall comprising a needle orifice and upstanding from the skin contact wall sidewalls and a top wall engaging a top shoulder of the needle support.
However, Carmel discloses a drug delivery device (Fig, 1-15) and wherein the device comprises a needle shield mechanism (38, 128, 130) comprises a skin contact wall (131) comprising a needle orifice(128) and upstanding from the skin contact wall sidewalls (Fig. 14) and a top wall engaging a top shoulder of the needle support (top end of 36 is engaged with top wall of 38, Fig. 14).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a needle shield guide so that the needle shield mechanism comprises a skin contact wall comprising a needle orifice and upstanding from the skin contact wall sidewalls and a top wall engaging a top shoulder of the needle support as taught by Carmel for the purpose of guiding the shield for preventing unwanted contact with the sharp needle (Carmel, ¶0072).
Re Claim 8, Just fails to disclose wherein the spring is in the form of a conical coil spring mounted between a top wall of the needle shield cover and a wall or support of a housing component of the delivery unit.
However, Carmel discloses a drug delivery device (Fig, 1-15) and wherein the device comprises a needle shield mechanism (38, 128, 130) and the spring (40) is in the form of a conical coil spring mounted between a top wall of the needle shield cover (131) and a wall or support of a housing component of the delivery unit (180, Fig. 15).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a needle shield guide so that the spring is in the form of a conical coil spring mounted between a top wall of the needle shield cover and a wall or support of a housing component of the delivery unit as taught by Carmel for the purpose of guiding the shield for preventing unwanted contact with the sharp needle (Carmel, ¶0072).
Re Claim 10, Just discloses wherein the needle actuation mechanism comprises an actuation disc (disc of 22) and an actuation lever (34), the actuation lever comprising a pivot portion (lower portion of 34 close to 32, Fig. 5b) and a lever arm ( top portion of 34) extending therefrom configured to engage an indent (26, catch, ¶0055) in the actuation disc upon initial actuation of the drug delivery device (Fig. 6a).
Re Claim 11, Just discloses the actuation disc is coupled to the rotor of the pump engine (¶0058), but it fails to disclose that the spring is in the form of a conical coil spring mounted between a top wall of the needle shield cover and a wall or support of a housing component of the delivery unit.
However, Carmel discloses a drug delivery device (Fig, 1-15) and wherein the device comprises a needle shield mechanism (38, 128, 130) comprising a needle shield cover (38, 128, 130) slidably movable from a retracted position (Fig. 9) within the housing (within the housing 52) to an extended position covering the needle (Fig. 15) and a spring (40, ¶0073) is in the form of a conical coil spring mounted between a top wall of the needle shield cover and a wall or support of a housing component of the delivery unit (, Fig. 14).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a needle shield mechanism so that the delivery unit further comprises the spring is in the form of a conical coil spring mounted between a top wall of the needle shield cover and a wall or support of a housing component of the delivery unit as taught by Carmel for the purpose of preventing unwanted contact with the sharp needle (Carmel, ¶0072).
Re Claim 12, Just discloses wherein the needle actuation mechanism comprises an actuation disc (disc of 22, ¶0058) and an actuation lever (34), the actuation lever comprising a pivot portion ( lower portion of 34, Fig. 6a) and a lever arm ( top portion of 34) extending therefrom configured to engage an indent (26) in the actuation disc upon initial actuation of the drug delivery device (Fig. 6a) and the pin extending from the needle support is coupled to the lever arm 26b, Fig. 2a).
Re Claim 13, Just discloses further including a drive unit (4, ¶0041) comprising an electronic control system (¶0041), a power source (¶0041), and a pump drive (5, ¶0041), wherein the pump drive comprises a rotary electrical motor (¶0058) and a coupling interface (¶0041) coupled to an output shaft of the rotary electrical motor (¶0041, the coupling interface coupling to a drive coupling interface of the pumping system of the delivery unit, the pump drive providing torque to a rotor of the pumping system (¶0041, mechanical power include a torque).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Just in view of Carmel and further in view of Marbet et al. (US. 20160184512A1) (“Marbet”)
Re Claim 9, Just discloses wherein the pumping system comprises a pump engine (5, Fig. ab, ¶0040) including - a stator (case of engine) - a rotor rotatably and axially slidably mounted at least partially in the stator (inner portion that rotate including disc 22, ¶0055, ¶0058), the rotor comprising a first axial extension having a first diameter (diameter of inner side of the notch 26,Fig. 6b) and the second axial extension having a second diameter greater than the first diameter (outer diameter of 22, ¶0065),but it fails to discloses that a first valve formed by a first valve seal mounted on the stator around the first axial extension, in conjunction with a first channel in the rotor that is configured to allow fluidic communication across the first valve seal when the first valve is in an open position, and - a second valve formed by a second valve seal mounted on the stator around the second axial extension, in conjunction with a second channel in a rotor that is configured to allow fluidic communication across the second valve seal when the second valve is an open position.
However, Marbet discloses a drug delivery device (Fig, 1-4) and wherein the device comprises a motor (72, ¶0083) has a rotor (rotary 102, ¶0051) and stator (outer case of 72, ¶0083), a first valve formed by a first valve seal mounted (interface seal around the reservoir and the needle 84, Fig. 3, ¶0082) on the stator around the first axial extension (72), in conjunction with a first channel in the rotor (inner the needle of 84) that is configured to allow fluidic communication across the first valve seal when the first valve is in an open position ( as the reservoir seal is pierced by 84), and - a second valve (76 is a seal connection outlet ¶0084) formed by a second valve seal mounted on the stator around the second axial extension (outlet extension, Fig. 3), in conjunction with a second channel in a rotor that is configured to allow fluidic communication across the second valve seal when the second valve is an open position ( 78).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify device of Just to include a first valve and a second valve so that a first valve formed by a first valve seal mounted on the stator around the first axial extension, in conjunction with a first channel in the rotor that is configured to allow fluidic communication across the first valve seal when the first valve is in an open position, and - a second valve formed by a second valve seal mounted on the stator around the second axial extension, in conjunction with a second channel in a rotor that is configured to allow fluidic communication across the second valve seal when the second valve is an open position as taught by Marbet for the purpose of pumping the fluid in specific channel without any leak (Marbet, ¶0082-¶0084).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783