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 .
Claims 1, 49, 63, and 190-208 are examined in this office action.
Claim Rejections - 35 USC § 112
Claim 49, 63, 195, 196-208 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 49, the phrase “about .1g to about 30g” claims a range of .1g to 30g that is modified by a range “about”. It is unclear what the desired range is and if multiple ranges are claimed. Claims 63, 195, 197, 201, 202, 203, and 208 also contain a range within a range.
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, 190, 191, 193, and 194 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franke et al. (US 2021/0178082 A1).
Regarding claim 1, Franke discloses a delivery device (drug delivery device 10, Fig. 1A) operable to automatically inject and deliver a fluid to a target site of a subject (“Device 10, as described above, is configured to inject a medicament into a patient’s body.” – Para [0042]), the delivery device comprising:
a lower body (housing 11, Fig. 1A);
an upper body (sleeve 19, Fig. 1B) configured to move relative to the lower body ("… to permit movement of sleeve 19 relative to housing 11. For example, sleeve 19 can move in a longitudinal direction parallel to longitudinal axis A-A." - Para [0045]) between a first upper body position (Fig. 6A) and a second upper body position (Fig. 6C) upon application of a force to the upper body ("Proximal movement of sleeve 19 by placing a distal end of sleeve 19 against a patient's body and moving housing 11 …" - Para [0046]);
an injection assembly comprising:
a fluid container (cartridge 18, Fig. 1B) configured to hold a fluid ("… a medicament from the cartridge 18 …" - Para [0048]), the fluid container attached to the upper body and moveable with the upper body ("… the cartridge 18 within housing 11 is moved in a proximal direction relative to housing 11.' - Para [0050]);
a needle (needle 17, Fig. 1B) attached to the fluid container (Fig. 1B), the needle having a proximal end for insertion into the target site of the subject ("… allows the distal end of the needle 17 to extend into the patient's body." - Para [0046]), wherein the delivery device is positionable such that the needle is inserted into the target site of the subject in response to the upper body moving from the first upper body position to the second upper body position (Proximal movement of sleeve 19 by placing a distal end of sleeve 19 against a patient's body and moving housing 11 in a distal direction will uncover the distal end of needle 17. Such relative movement allows the distal end of needle 17 to extend into the patient's body." - Para [0046]);
a plunger (plunger 33, Fig. 2); and
a first releasable retainer member (protrusions 36, Fig. 2) configured to release the plunger in response to the upper body reaching the second upper body position, wherein the first releasable retainer member releasing the plunger ("As the needle sleeve 26 is moved proximally into the housing 21 … this causes the protrusions 36 to disengage from the recesses 37 thereby releasing the plunger 33 which then moves under the force of the spring 32 into the reservoir 28." - Para [0058]) causes the plunger to urge the fluid out of the fluid container ("The spring 32 is arranged to urge the plunger 33 against the piston 24 and into the reservoir 28 to expel medicament from the reservoir 28 during use." - Para [0054]) and into the needle to inject the fluid into the target site through the proximal end of the needle ("... medicament can be expelled from the reservoir 28 via the needle 31 ..." - Para [0053]) when the proximal end of the needle is inserted into the target site ("Such relative movement allows the distal end of needle 17 to extend into the patient's body." - Para [0046]).
Regarding claim 190, Franke discloses the delivery device (drug delivery device 10, Fig. 1A) as recited above, wherein
the injection assembly further comprises an actuator (tubular element 35, Fig. 2)
moveable relative to the first releasable retainer member (protrusions 36, Fig. 2) from a first actuator position (Fig. 6A) to a second actuator position (Fig. 6B) in response to the upper body moving from the first upper body position to the second upper body position ("As the needle sleeve 26 is moved proximally into the housing 21, an end of the needle sleeve 26 engages the tubular element 35, causing the tubular element 35 to rotate about the axis A of the injection device 20." - Para [0058]), wherein the first releasable retainer releases the plunger in response to the actuator moving to the second actuator position ("This rotation causes the protrusions 36 to disengage from the recesses 37, thereby releasing the plunger 33 …" - Para [0058]).
Regarding claim 191, Franke discloses the delivery device (drug delivery device 10, Fig. 1A) as recited above, wherein
the actuator (tubular element 35, Fig. 2) is configured to prevent rotation of the plunger ("The tubular element 35 includes protrusions 36 that engage recesses 37 in the plunger 33, such that in the position illustrated in FIG. 2 the plunger 33 is prevented from moving …" - Para [0057]) relative to the first releasable retainer member (protrusions 36, Fig. 2) when the actuator is in the first actuator position (Fig. 2).
Regarding claim 193, Franke discloses the delivery device (drug delivery device 10, Fig. 1A) as recited above, further comprising
a driver (needle unit 23, Fig. 2) moveable relative to the lower body (needle sleeve 26, Fig. 2) (“… rotating a part of the needle sleeve 26 about the axis A causes one of the needle unit 23 … to move axially within the housing 21 …” – Para [0063]) from a first driver position (Fig. 6A) to a second driver position (Fig. 6C), wherein the driver is attached to the lower body when the driver is in the first driver position (Fig. 6A), wherein the driver moves proximally relative to the needle when the driver moves from the first driver position to the second driver position ("… drive the needle unit 23 in an axial direction towards the cartridge 22." - Para [0077]), wherein the driver comprises an inner cavity (See annotated Fig. 2) configured to house the needle (needle 31, Fig. 2) when the driver is in the second driver position (Fig. 6C) and the upper body (housing 21, Fig. 6C) is in the second upper body position (Fig. 6C).
PNG
media_image1.png
346
804
media_image1.png
Greyscale
Regarding claim 194, Franke discloses the delivery device (drug delivery device 10, Fig. 1A) as recited above, further comprising
the driver (needle unit 23, Fig. 2) is attached to the lower body (needle sleeve 26, Fig. 2) by a second releasable retainer member (second part 39, Fig. 7B) configured to secure the driver in the first driver position and release the driver to permit movement of the driver the second driver position ("… the protrusion will prevent axial movement of the needle sleeve 26 into the housing 21 until the second part 39 of the needle sleeve 26 has been rotated to align the axially extending slot with the protrusion." - Para [0068]) in response to the plunger reaching the second plunger position ("... Proximal movement of the needle sleeve 26 releases the catch of the piston drive mechanism to release the plunger …" - Para [0082]).
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) 49, 63, 196, 197, 201, 202, 203, and 208 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehawej et al. (US Pub No. 20170239427 A1) in view of Edwards et al. (US Pub No. 2022/0040413 A1).
Regarding claim 49, Mehawej in view of Edwards discloses a method (Mehawej, “… a method for reducing failure …” – Para [0014]) for reducing or preventing hemorrhage, comprising
intramuscularly administering an antifibrinolytic agent (Mehawej, "Injection device 100 can also be used to inject medicaments … antifibrinolytic agents ..." - Para [0057]) at a rate of no less than 50 mg/s (Mehawej, ".. A flow rate of about … 1.0 mL/sec …" - Para [0063]).
Mehawej does not expressly disclose intramuscularly administering an antifibrinolytic agent in a dose of about .1g to about 30g.
Edwards teaches intramuscularly administering an antifibrinolytic agent in a dose of about .1g to about 30g ("… a single-dose device container an amount medicament to be delivered of approximately .4mg …" - Para [0183]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Mehawej to include intramuscularly administering an antifibrinolytic agent in a dose of about .1g to about 30g as taught by Edwards for medicament delivery (Edwards, Para [0183]).
Examiner interprets 50 mg/s to be equivalent to .05 mL/s.
Regarding claim 63, Mehawej in view of Edwards discloses a method (Mehawej, “… a method for reducing failure …” – Para [0014]) for reducing or preventing hemorrhage, comprising
intramuscularly administering an antifibrinolytic agent (Mehawej, "Injection device 100 can also be used to inject medicaments … antifibrinolytic agents ..." - Para [0057]) in about 1 mL to about 20 mL (Mehawej, "… injector device 100 can deliver an injection of up to about 3 mL per injection …" - Para [0060]) at a fluid velocity of no less than 0.2 m/s (Mehawej, "… average stream velocity within the needle of at least about 1,000 cm/s …" - Para [0064]).
Mehawej does not expressly disclose intramuscularly administering an antifibrinolytic agent in a dose of about 0.1 g to about 30 g.
Edwards teaches intramuscularly administering an antifibrinolytic agent in a dose of about 0.1 g to about 30 g ("… a single-dose device container an amount medicament to be delivered of approximately .4mg …" - Para [0183]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Mehawej to include intramuscularly administering an antifibrinolytic agent in a dose of about .1g to about 30g as taught by Edwards for medicament delivery (Edwards, Para [0183]).
Regarding claim 196, Mehawej in view of Edwards discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
the antifibrinolytic agent (Mehawej, "Injection device 100 can also be used to inject medicaments … antifibrinolytic agents ..." - Para [0057]) is administered at a rate of not less than 100 mg/s (Mehawej, ".. A flow rate of about … 1.0 mL/sec …" - Para [0063]) , no less than 200 mg/s, no less than 300 mg/s, no less than 400 mg/s, or no less than 500 mg/s.
Examiner interprets 1 mL/sec to be equivalent to 1,000 mg/s.
Regarding claim 197, Mehawej in view of Edwards discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
the antifibrinolytic agent (Mehawej, “Injection device 100 can also be used to inject medicaments … antifibrinolytic agents …” – Para [0057]) is administered at a rate of about 250 mg/s (Mehawej, "…a flow rate of about .2 mL/sec …" - Para [0063]) or about 330 mg/s.
Examiner interprets 250mg/s to be equivalent to .25 mL/sec.
Regarding claim 201, Mehawej in view of Edwards discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej does not expressly disclose that the dose is about .5g to about 2g.
Edwards teaches that the dose is about .5g to about 2g ("… a single-dose device container an amount medicament to be delivered of approximately .4mg …" - Para [0183]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Mehawej to include that the dose is about .5g to about 2g as taught by Edwards for medicament delivery (Edwards, Para [0183]).
Regarding claim 202, Mehawej in view of Edwards discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
the dose is provided in about 1 mL to about 10 mL of fluid (Mehawej, "… injector device 100 can deliver an injection of up to about 3 mL per injection …" - Para [0060]).
Regarding claim 203, Mehawej in view of Edwards discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
the antifibrinolytic agent (Mehawej, “Injection device 100 can also be used to inject medicaments … antifibrinolytic agents …” – Para [0057]) is administered at a fluid velocity of no less than .5 m/s, no less than 1m/s, no less than 2m/s, or no less than 4m/s (Mehawej, "… average stream velocity within the needle of at least about 1,000 cm/s …" - Para [0064]).
Regarding claim 208, Mehawej in view of Edwards discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej does not expressly disclose that the dose is about .5g to about 2g.
Edwards teaches that the dose is about .5g to about 2g ("… a single-dose device container an amount medicament to be delivered of approximately .4mg …" - Para [0183]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Mehawej to include that the dose is about .5g to about 2g as taught by Edwards for medicament delivery (Edwards, Para [0183]).
Claim(s) 192 and 195 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franke et al. (US 2021/0178082 A1) in view of Edwards et al. (US Pub No. 2022/0040413 A1).
Regarding claim 192, Franke in view of Edwards discloses the delivery device (Franke,
drug delivery device 10, Fig. 1A) as recited above, wherein
the first releasable retainer member (Franke, protrusions 36, Fig. 2) is in engagement
with the plunger (Franke, plunger 33, Fig. 2).
Franke does not expressly disclose that the first releasable retainer member is in engagement with the plunger through at least interlocking threads.
Edwards teaches that the first releasable retainer member is in engagement with the plunger through at least interlocking threads ("… the protrusion 6323 includes a threaded screw portion for insertion into a corresponding threaded member …" - Para [0152]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the first releasable retainer member is in engagement with the plunger through at least interlocking threads as taught by Edwards to cause movement of a member (Edwards, Para [0160]).
Regarding claim 195, Franke in view of Edwards discloses the delivery device (Franke,
drug delivery device 10, Fig. 1A) as recited above, wherein
Franke does not expressly disclose that the fluid container is configured to hold an amount of the fluid between about 1 mL and no more than about 10 mL.
Edwards teaches that the fluid container (prefilled syringe 4200, Fig. 2) is configured to hold an amount of the fluid between about 1 mL and no more than about 10 mL ("… a medical injector can include two prefilled syringes, each containing up to 1 mL of medicament (or more) …" - Para [0184]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the fluid container is configured to hold an amount of the fluid between about 1 mL and no more than about 10 mL as taught by Edwards for medicament delivery (Edwards, Para [0183]).
Claim(s) 198 and 205 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehawej et al. (US Pub No. 20170239427 A1) in view of Edwards et al. (US Pub No. 2022/0040413 A1) and in further view of Akinc (US Pub No. 20260000701 A1).
Regarding claim 198, Mehawej in view of Edwards and Akinc discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej in view of Edwards does not expressly disclose that the antifibrinolytic agent comprise tranexamic acid (TXA).
Akinc teaches that the antifibrinolytic agent comprise tranexamic acid (TXA) ("… antifibrinolytics such as … tranexamic acid …" - Para [0236]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the antifibrinolytic agent comprise tranexamic acid (TXA) as taught by Akinc for treating a bleeding disorder (Akinc, Para [0236]).
Regarding claim 205, Mehawej in view of Edwards and Akinc discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej in view of Edwards does not expressly disclose that the antifibrinolytic agent comprise tranexamic acid (TXA).
Akinc teaches that the antifibrinolytic agent comprise tranexamic acid (TXA) ("… antifibrinolytics such as … tranexamic acid …" - Para [0236]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the antifibrinolytic agent comprise tranexamic acid (TXA) as taught by Akinc for treating a bleeding disorder (Akinc, Para [0236]).
Claim(s) 199, 200, 206, and 207 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehawej et al. (US Pub No. 20170239427 A1) in view of Edwards et al. (US Pub No. 2022/0040413 A1) and in further view of Mulder et al. (US Pub No. 2020/0206280 A1).
Regarding claim 199, Mehawej in view of Edwards and Mulder discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej in view of Edwards does not expressly disclose that the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage.
Mulder teaches that the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage ("... The subject diagnosed with brain injury has suffered an intracerebral hemorrhage." - Para [0181]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage as taught by Mulder for treating brain injury (Mulder, Para [0175]).
Regarding claim 200, Mehawej in view of Edwards and Mulder discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej in view of Edwards does not expressly disclose that the posttraumatic hemorrhage is caused by a traumatic brain injury.
Mulder teaches that the posttraumatic hemorrhage is caused by a traumatic brain injury ("... The subject diagnosed with brain injury has suffered an intracerebral hemorrhage." - Para [0181]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the posttraumatic hemorrhage is caused by a traumatic brain injury as taught by Mulder for treating brain injury (Mulder, Para [0175]).
Regarding claim 206, Mehawej in view of Edwards and Mulder discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej in view of Edwards does not expressly disclose that the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage.
Mulder teaches that the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage ("... The subject diagnosed with brain injury has suffered an intracerebral hemorrhage." - Para [0181]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage as taught by Mulder for treating brain injury (Mulder, Para [0175]).
Regarding claim 207, Mehawej in view of Edwards and Mulder discloses the method (Mehawej, “… a method for reducing failure …” – Para [0014]) as recited above, wherein
Mehawej in view of Edwards does not expressly disclose that the posttraumatic hemorrhage is caused by a traumatic brain injury.
Mulder teaches that the posttraumatic hemorrhage is caused by a traumatic brain injury ("... The subject diagnosed with brain injury has suffered an intracerebral hemorrhage." - Para [0181]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Franke to include that the posttraumatic hemorrhage is caused by a traumatic brain injury as taught by Mulder for treating brain injury (Mulder, Para [0175]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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.
/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights