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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/06/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in FIG. 3, reference character “108” has been used to designate both proximal end and syringe assembly.
The drawings are objected to is objected to because in FIG. 4, reference character “108” was used to identify syringe assembly, which is the specification has been given reference character “118”.
The drawings are objected to because in FIG. 6 and FIG. 8, reference characters “150”, gear train, and “152”, first gear, appear to be identifying the same structure.
The drawings are objected to because in FIG. 14 and FIG. 16, reference number “164”, which in the specification has been identified as protrusions of the follower 156, is incorrectly identifying a structure.
The drawings are objected to because in FIG. 18, reference characters “190”, gear train, and “192”, first gear, appear to be identifying the same structure.
The drawings are objected to because in FIG. 32 and FIG. 33, reference characters “702”, gear train, and “704”, first gear, appear to be identifying the same structure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In the second line of paragraph [0084], a comma is missing where the specification states “ The needle shield 414 the shield puller 416…”. Appropriate correction is required.
In the third line of paragraph [0084], the word “obscures” should be changed to “obscure” based on proper English grammar. Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 3 and 18 are objected to because of the following informalities: In the third and fourth lines of claim 3 and the fourth and fifth lines of claim 18, the claims state “…in the second configuration the follower is disposed apart from and permits actuation of the user input.”. The examiner suggests adding specification to what the follower is disposed apart from to remove possible speculation. If the intention is for the follower to be disposed apart from the user input, the examiner suggest modifying the claim to state “…in the second configuration the follower is disposed apart from the user input and permits actuation of the user input.”. Appropriate correction is required. For examination purposes, the examiner will interpret the claims to mean that of the suggested modification.
Claim 11 is objected to because of the following informalities: In the fourteenth and fifteenth lines of the claim, the claim states “…in the first configuration the drive mechanism inhibiting actuation…in the second configuration the drive mechanism permitting actuation…”. The terms “inhibiting” and “permitting” are in the wrong tense per English grammar. The examiner suggest modifying the claim to state “…in the first configuration the drive mechanism inhibits actuation…in the second configuration the drive mechanism permits actuation…”. Appropriate correction is required. For examination purposes, the examiner will interpret the claim to mean that of the suggested modification.
Claim 14 is objected to because of the following informalities: In the second line of the claim, the claim states “…a disposable portion that is configured to be movable relative to the reusable portion…”. The claim appears to be missing an article between the terms “be” and “movable”. The examiner suggests modifying the claim to state “…a disposable portion that is configured to be a movable relative to the reusable portion…”. Appropriate correction is required. For examination purposes, the examiner will interpret the claim to mean that of the suggested modification.
Claim Rejections - 35 USC § 112
Claims 3, 4, 11, 13, 14, 17, 18 and 19 are 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.
Claim 3 recites the limitation “a drive mechanism” in the second line of the claim. However, this recitation of the limitation follows a previous recitation of “a drive mechanism” in the sixteenth line of the claim 1, upon which claim 3 is dependent on. It is unclear to the examiner as to if these are separate “drive mechanisms” or the same. The examiner suggests if the “drive mechanisms” are the same, modifying the article “a” to “the” in the claim 13 recitation. If the “user inputs” are different, the examiner suggests modifying the name of either recitations of the limitation, or adding a locational identifier after one to differentiate. For the purposes of examination, the examiner will interpret both recitations of “a drive mechanism” to be the same “drive mechanism”.
Claim 4 recites the limitation "the skin of a subject" in the fifth, seventh, and ninth lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the housing" in the second, fourth, sixth, eighth, ninth, nineteenth, and twenty-third lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the distal end" in the sixth, seventh, nineteenth, twenty-first, and twenty-third lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the first housing" in the eleventh and twenty-first lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the sensor" in the twentieth and twenty-second lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “a user input” in the eighth and ninth lines of the claim. However, this recitation of the limitation follows a previous recitation of “a user input” in the first line of the claim. It is unclear to the examiner as to if these are separate “user inputs” or the same. The examiner suggests if the “user inputs” are the same, modifying the article “a” to “the” in the second recitation. If the “user inputs” are different, the examiner suggests modifying the name of either recitations of the limitation, or adding a locational identifier after one to differentiate. For the purposes of examination, the examiner will interpret both recitations of “a user input” to be the same “user input”.
Claim 13 recites the limitation "the housing" in the third, fifth, eighth, and ninth lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the skin" in the third, fifth, and ninth lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the sensor" in the fifth, seventh, and eighth lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the actuating step" in the sixth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: In the third line of the claim, the claim states “detecting contact between a distal end of the housing and the skin of a subject”, but fails to articulate what element is completing the action of detecting contact. Omitting this element leads to confusion as to what the applicant is attempting to claim. The examiner suggest modifying the claim to clarify what element is completing the action of detecting contact. For the purposes of examination, the examiner will interpret “a sensor” to be completing the action of detecting contact.
Claim 14 recites the limitation "the syringe assembly" in the fifth and eighth lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the second housing" in the sixth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the first housing" in the eighth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 17 and 19 recites the limitation “a syringe assembly” in the second line of both of the claims. However, this recitation of the limitation follows a previous recitation of “the syringe assembly” in the fifth and eighth lines of the claim 14 (see insufficient antecedent basis rejection above), upon which claims 17 and 19 are a dependent on. It is unclear to the examiner if these are separate “syringe assemblies” or the same. The examiner suggests if the “syringe assemblies” are the same, modifying the article “a” to “the” in claims 17 and 19, and amending the antecedent basis of claim 14. If the “syringe assemblies” are different, the examiner suggests modifying the name of either recitations of the limitation, or adding a locational identifier after one to differentiate. For the purposes of examination, the examiner will interpret recitations of “syringe assembly” to be the same “syringe assembly”.
Claim 18 recites the limitation “a drive mechanism” in the third line of the claim. However, this recitation of the limitation follows a previous recitation of “a drive mechanism” in the fourth line of the claim 14, upon which claim 18 is a dependent. It is unclear to the examiner if these are separate “drive mechanisms” or the same. The examiner suggests if the “drive mechanisms” are the same, modifying the article “a” to “the” in the claim 18 recitation. If the “drive mechanisms” are different, the examiner suggests modifying the name of either recitations of the limitation, or adding a locational identifier after one to differentiate. For the purposes of examination, the examiner will interpret both recitations of “a drive mechanism” to be the same “drive mechanism”.
Claim 19 recites the limitation "the distal end" in the sixth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the second housing" in the sixth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Denzer et al. (United States Patent Application Publication No. US 2015/0045729 A1; herein, Denzer), and further in view of Grimoldby et al. (United States Patent Application Publication No. US 2018/0250471 A1; herein, Grimoldby).
Regarding claim 1, Denzer discloses a therapeutic agent delivery device (autoinjector apparatus 100), comprising:
a disposable portion (cassette 200), comprising:
a first housing comprising a distal end (FIG. 2A, outer housing 210 having proximal end wall 214);
a syringe assembly carried by the first housing (FIG. 2C, syringe 260), the syringe assembly comprising:
a chamber comprising a passageway (FIG. 2C, barrel 261 defines fluid chamber 262);
a needle (injection needle 265) in communication with the passageway (FIG. 2C, [0085], “The syringe 260 may further comprise a moveable plunger-stopper 264, disposed within the fluid chamber 262 of the barrel 260, for expelling the predetermined dose of the pharmaceutical product 267 from the chamber 261 so that it may be dispensed through the injection needle 265.”);
the syringe assembly being translatable relative to the first housing ([0087], “unlatched inner sleeve 220 containing the syringe 260 [can] be freely moved by the insertion drive 330, which pushes on the inner sleeve pin 268 to move the inner sleeve 220 relative to the outer housing 210”) from a stowed configuration ([0087, home position) to a deployed configuration ([0087], injection position), in the stowed configuration the needle being disposed proximally relative to the distal end of the first housing (FIG. 2C), and in the deployed configuration the needle is at least partially extended distally from the distal end of the first housing ([0087], “the injection needle 265 is in a needle extended position that allows it to penetrate the skin at the injection site”);
a reusable portion (autoinjector 300) configured to detachably carry the disposable portion ([0081], [0114], autoinjector 300 may be reusable and contains cassette door 308 which opens to accept cassette 200 pre-injection, and opens post-injection for removal of used cassette 200), the reusable portion comprising:
a second housing (casing 302);
a drive mechanism (insertion drive 330) carried by the second housing and coupled to the syringe assembly (FIG. 8, [0087], [0111]),
a user input (start button 307), the user input carried by the second housing (FIG. 6F) and operatively coupled to the drive mechanism ([0105], [0109], start button 307 and insertion drive 330 are couple by way of microprocessor 305), wherein in response to actuation of the user input the drive mechanism is configured to translate the syringe assembly relative to the first housing from the stowed configuration and the deployed configuration ([0087], insertion drive 330 moves syringe 260 from home position to injection position).
Denzer does not disclose the user input comprises a first configuration and a second configuration prior to actuation, in the first configuration the drive mechanism is configured to inhibit actuation of the user input, and in the second configuration the drive mechanism is configured to permit actuation of the user input.
However, Grimoldby teaches the user input comprises a first configuration (FIG. 21(a)) and a second configuration prior to actuation (FIG. 22(a)), in the first configuration the drive mechanism is configured to inhibit actuation of the user input ([0196], stowed position), and in the second configuration the drive mechanism is configured to permit actuation of the user input ([0199], working position). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion and user input disclosed by Denzer to have specific configurations of the user input corresponding to when and when not the device can be activated as taught by Grimoldby in order to provide a visual indication to the user that the trigger button has been unlocked and that the device is ready for injection ([0199]).
Regarding claim 2, in the modified device of Denzer, Denzer discloses the user input is actuatable by a user ([0109], “pressing the start button”) to actuate a rotary actuator of the drive mechanism ([0111], insertion drive motor 331).
Regarding claim 3, in the modified device of Denzer, Denzer does not disclose in the first configuration a follower of a drive mechanism is configured to contact the user input to inhibit actuation of the user input, and in the second configuration the follower is disposed apart from and permits actuation of the user input. However, Grimoldby teaches in the first configuration a follower of a drive mechanism (interlock component 250) is configured to contact the user input to inhibit actuation of the user input, and in the second configuration the follower is disposed apart from and permits actuation of the user input ([0196]-[0198], movement of the interlock component 250 moves the trigger button 200 proximally). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive mechanism of the modified device disclosed by Denzer to include a follower which permits activation of the device as taught by Grimoldby in order that accidental or premature operation of the device is avoided ([0011]) prior to movement of the follower.
Regarding claim 4, in the modified device of Denzer, Denzer discloses the second housing comprises a distal end (FIG. 6A-6D, proximal wall 318), in the deployed configuration the needle is at least partially extended distally from the distal end of the second housing ([0087], “an injection position, where the injection needle 265 is in a needle extended position that allows it to penetrate the skin at the injection site”), the reusable portion further comprising a sensor (skin sensor 380) configured to detect contact between the distal end of the second housing and the skin of a subject (FIG. 8, [0102], “The skin sensor 380 determines when the proximal end wall 318 of the autoinjector 300 touches or contacts skin without the need to provide downward pressure on the injection-site area.”), the reusable portion is configured to inhibit actuation of the user input when the sensor does not detect contact between the distal end of the second housing and the skin of the subject ([0103], “no-touch” state), and the reusable portion is configured to permit actuation of the user input when the sensor detects contact between the distal end of the second housing and the skin of the subject ([0103], “touch OK” state).
Regarding claim 6, in the modified device of Denzer, Denzer does not disclose in the first configuration the user input is in a distal position, and in the second configuration the user input is in a position proximal to the distal position. However, Grimoldby teaches in the first configuration the user input is in a distal position ([0196], stowed position) and in the second configuration the user input is in a position proximal to the distal position ([0199], working position). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion and user input of the modified device disclose by Denzer to have specific configurations of the user input corresponding to when and when not the device can be activated as taught by Grimoldby in order to provides a visual indication to the user that the trigger button has been unlocked and that the device is ready for injection ([0199]).
Regarding claim 7, in the modified device of Denzer, Denzer does not disclose the drive mechanism includes a guide, and the user input includes one or more hook members that engage the guide when the user input is in the first configuration. However, Grimoldby teaches the drive mechanism includes a guide (guide wall 150), and the user input includes one or more hook members (locking finger 214) that engage the guide when the user input is in the first configuration (FIG. 21(a), [0196]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive mechanism and user input of the modified device disclosed by Denzer to have a guide and hook engagement system as taught by Grimoldby in order to provide a simple and reliable means for positively blocking movement of the trigger component ([0011]).
Regarding claim 10, in the modified device of Denzer, Denzer discloses the chamber of the syringe assembly contains a therapeutic agent (FIG. 2C, barrel 261 defines fluid chamber 262 containing pharmaceutical product 267).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Denzer in view of Grimoldby as applied to claim 2 above, and further in view of Henderson et al. (United States Patent Application Publication No. US 2015/0080810 A1; herein, Henderson).
Regarding claim 5, in the modified device of Denzer, Denzer discloses the disposable portion further comprises a needle shield (needle shield 266) detachably coupled to the distal end of the first housing ([0094], "removing the needle shield 266 and uncovering the injection needle 265") and is configured to obscure the needle in the stowed configuration (FIG. 4F, [0089]).
Denzer does not disclose the reusable portion further comprising a sensor configured to detect the needle shield, the reusable portion is configured to inhibit actuation of the user input when the sensor detects that the needle shield is coupled to the distal end of the first housing, and the reusable portion is configured to permit actuation of the user input when the sensor detects that the needle shield is detached from the distal end of the first housing.
However, Henderson teaches the reusable portion further comprising a sensor ([0030], first sensor) configured to detect the needle shield ([0030], “a first sensor may transmit a signal to the data storage device 400 when the needle sheath 110 is removed”), the reusable portion is configured to inhibit actuation of the user input when the sensor detects that the needle shield is coupled to the distal end of the first housing (first sensor would transfer data to microprocessor disclosed by Denzer to inhibit actuation), and the reusable portion is configured to permit actuation of the user input when the sensor detects that the needle shield is detached from the distal end of the first housing (first sensor would transfer data to microprocessor disclosed by Denzer to permit actuation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion of the modified device disclosed by Denzer to incorporate a needle shield presence sensor as taught by Henderson in order to measure or determine functional parameters of the disposable or reusable portions of the device ([0030]), and make a decision if activation is allowable.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Denzer in view of Grimoldby as applied to claim 7 above, and further in view of Atterbury et al. (WIPO International Publication No. WO 2020/131552 A1; herein, Atterbury).
Regarding claim 8, in the modified device of Denzer, Denzer does not disclose the drive mechanism includes a follower rotatable relative to the guide, and a portion of the follower engages the one or more hook members of the user input during rotation to release the one or more hook members from the guide, thereby allowing the user input to move to the second configuration.
However, Grimoldby teaches the drive mechanism includes a follower (interlock component 250), and a portion of the follower engages the one or more hook members of the user input during rotation to release the one or more hook members from the guide ([0198], “proximal movement of the interlock component 250 pushes the locking fingers 214, and therefore the trigger button 200, in the proximal direction”), thereby allowing the user input to move to the second configuration ([0196]-[0198], movement of the interlock component 250 moves the trigger button 200 proximally). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive mechanism of the modified device disclosed by Denzer to include a follower which permits activation of the device by interacting with hook members as taught by Grimoldby in order to allow controlled displacement of the trigger component to the firing position ([0061]).
Denzer in view of Grimoldby still does not disclose the follower being a rotatable relative to the guide. However, Atterbury teaches the follower being a rotatable relative to the guide (FIG. 43, [0086], actuator shuttle 224 rotates relative to and activates a pressure generating actuator 226 to begin injection). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the follower taught by Grimoldby in the drive mechanism of the modified device disclosed by Denzer to rotate the follower as taught by Atterbury in order that the device move from inhibiting actuation to permitting actuation ([0007]-[0008]). Also, by allowing the device components to operate in more than one direction, the device is able to be more compact while using all necessary parts for proper injection.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Denzer in view of Grimoldby and Atterbury as applied to claim 8 above, and further in view of Radmer et al. (United States Patent Application Publication No. US 2014/0039409 A1; herein, Radmer).
Regarding claim 9, in the modified device of Denzer, Denzer discloses when the one or more hook members are released from the guide (Grimoldby - [0198], “proximal movement of the interlock component 250 pushes the locking fingers 214, and therefore the trigger button 200, in the proximal direction”).
Denzer in view of Grimoldby and Atterbury still does not disclose a spring provides a biasing force to proximally move the user input to the second configuration. However, Radmer teaches a spring (helical compression spring 25) provides a biasing force to proximally move the user input to the second configuration ([0047], “The sliding element 35 will rotate because of the freedom in the housing 20 and the torque generated by the pretensioned helical compression spring 25. Furthermore, the injection button 5 is rotated and axially translated, in response to the axial displacement and rotation of the sliding element 35, from an unloaded or unprepared state indicated by its non-protruding placement inside the housing 20 of injection device to a loaded or prepared state”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive mechanism of the modified device disclosed by Denzer to include a spring which supports movement of the user input as taught by Radmer in order to store axial spring force and a torque for subsequent movement ([0046], [0047], [0050]), both proximally and distally, of the user input.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Denzer, and further in view of Grimoldby and Henderson.
Regarding claim 11, Denzer discloses a method of moving a user input (start button 307) of a therapeutic agent delivery device (autoinjector apparatus 100), the delivery device including a syringe assembly (syringe 260) carried by the housing (outer housing 210), the syringe assembly comprising a chamber comprising a passageway (FIG. 2C, barrel 261 defines fluid chamber 262), a needle (injection needle 265) in communication with the passageway (FIG. 2C, [0085], “The syringe 260 may further comprise a moveable plunger-stopper 264, disposed within the fluid chamber 262 of the barrel 260, for expelling the predetermined dose of the pharmaceutical product 267 from the chamber 261 so that it may be dispensed through the injection needle 265.”), the syringe assembly being translatable relative to the housing ([0087], “unlatched inner sleeve 220 containing the syringe 260 [can] be freely moved by the insertion drive 330, which pushes on the inner sleeve pin 268 to move the inner sleeve 220 relative to the outer housing 210”) from a stowed configuration ([0087], home position) to a deployed configuration ([0087], injection position), in the stowed configuration the needle being disposed proximally relative to the distal end of the housing (FIG. 2C), and in the deployed configuration the needle at least partially extending distally from the distal end of the housing ([0087], “the injection needle 265 is in a needle extended position that allows it to penetrate the skin at the injection site”), a drive mechanism (insertion drive 330) carried by the housing and coupled to the syringe assembly (FIG. 8, [0087], [0111]), a user input (start button 307), the user input carried by the housing (FIG. 6F) and operatively coupled to the drive mechanism ([0105], [0109], start button 307 and insertion drive 330 are couple by way of microprocessor 305), wherein in response to actuation of the user input the drive mechanism is configured to translate the syringe assembly relative to the first housing from the stowed configuration and the deployed configuration ([0087], insertion drive 330 moves syringe 260 from home position to injection position), and detecting a presence of a needle shield (needle shield 266), wherein the needle shield is detachably coupled to the distal end of the housing ([0094], "removing the needle shield 266 and uncovering the injection needle 265") and obscuring the needle in the stowed configuration (FIG. 4F, [0089]).
Denzer does not disclose wherein the user input comprises a first configuration and a second configuration prior to actuation, in the first configuration the drive mechanism inhibiting actuation of the user input, and in the second configuration the drive mechanism permitting actuation of the user input, the method comprising the steps of: providing the therapeutic agent delivery device with the user input in the first configuration, and the therapeutic agent delivery device inhibiting actuation of the user input when the sensor detects that the needle shield is coupled to the distal end of the first housing; and actuating the user input to the second configuration when the sensor detects that the needle shield is detached from the distal end of the housing.
However, Grimoldby teaches wherein the user input comprises a first configuration (FIG. 21(a)) and a second configuration prior to actuation (FIG. 22(a)), in the first configuration the drive mechanism inhibiting actuation of the user input ([0196], stowed position), and in the second configuration the drive mechanism permitting actuation of the user input ([0199], working position), the method comprising the steps of: providing the therapeutic agent delivery device with the user input in the first configuration ([0196], trigger button 200 starts in stowed position). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion and user input disclosed by Denzer to have specific configurations of the user input corresponding to when and when not the device can be activated as taught by Grimoldby in order to provide a visual indication to the user that the trigger button has been unlocked and that the device is ready for injection ([0199]).
Denzer in view of Grimoldby still does not disclose the therapeutic agent delivery device inhibiting actuation of the user input when the sensor detects that the needle shield is coupled to the distal end of the first housing; and actuating the user input to the second configuration when the sensor detects that the needle shield is detached from the distal end of the housing.
However, Henderson teaches the therapeutic agent delivery device inhibiting actuation of the user input when the sensor ([0030], first sensor) detects that the needle shield is coupled to the distal end of the first housing ([0030], “a first sensor may transmit a signal to the data storage device 400 when the needle sheath 110 is removed”, first sensor would transfer data to microprocessor disclosed by Denzer to inhibit actuation); and actuating the user input to the second configuration when the sensor detects that the needle shield is detached from the distal end of the housing (first sensor would transfer data to microprocessor disclosed by Denzer to permit actuation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion of the modified device disclosed by Denzer needle shield presence sensor as taught by Henderson in order to measure or determine functional parameters of the disposable or reusable portions of the device ([0030]), and make a decision if activation is allowable.
Regarding claim 12, in the modified device of Denzer, Denzer does not disclose the user input is in a distal position when in the first configuration, and in a position proximal to the distal position when in the second configuration. However, Grimoldby teaches the user input is in a distal position when in the first configuration ([0196], stowed position) and in a position proximal to the distal position when in the second configuration ([0199], working position). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion and user input of the modified device disclose by Denzer to have specific configurations of the user input corresponding to when and when not the device can be activated as taught by Grimoldby in order to provides a visual indication to the user that the trigger button has been unlocked and that the device is ready for injection ([0199]).
Regarding claim 13, in the modified device of Denzer, Denzer discloses detecting contact between a distal end of the housing and the skin of a subject (FIG. 8, [0102], “The skin sensor 380 determines when the proximal end wall 318 of the autoinjector 300 touches or contacts skin without the need to provide downward pressure on the injection-site area.”), the therapeutic agent delivery device inhibiting actuation of the user input when the sensor does not detect contact between the distal end of the housing and the skin of the subject ([0103], “no-touch” state), and the actuating step further comprises: actuating the user input to the second configuration when the sensor detects contact between the distal end of the housing and the skin of the subject ([0103], “touch OK” state).
Denzer does not disclose actuating the user input to the second configuration when the sensor detects that the needle shield is detached from the distal end of the housing. However, Henderson teaches actuating the user input to the second configuration when the sensor detects that the needle shield is detached from the distal end of the housing ([0030], “a first sensor may transmit a signal to the data storage device 400 when the needle sheath 110 is removed”, first sensor would transfer data to microprocessor disclosed by Denzer to inhibit/permit actuation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion of the modified device disclosed by Denzer needle shield presence sensor as taught by Henderson in order to measure or determine functional parameters of the disposable or reusable portions of the device ([0030]), and make a decision if activation is allowable.
Claims 14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Denzer, and further in view of Grimoldby.
Regarding claim 14, Denzer discloses a therapeutic agent delivery device (autoinjector apparatus 100), comprising a reusable portion (autoinjector 300) to detachably carry ([0081], [0114], autoinjector 300 may be reusable and contains cassette door 308 which opens to accept cassette 200 pre-injection, and opens post-injection for removal of used cassette 200) a disposable portion (cassette 200) that is configured to be movable relative to the reusable portion between a stowed configuration ([0087], home position) and a deployed configuration ([0087], injection position) for a dispensing of a therapeutic agent ([0085], pharmaceutical product 267), the reusable portion comprising a reusable portion housing (casing 302), a drive mechanism (insertion drive 330) carried by the reusable portion housing and coupled to the syringe assembly (syringe 260; FIG. 8, [0087], [0111]), a user input (start button 307), the user input carried by the second housing (FIG. 6F) and operatively coupled to the drive mechanism ([0105], [0109], start button 307 and insertion drive 330 are couple by way of microprocessor 305), wherein in response to actuation of the user input the drive mechanism is configured to translate the syringe assembly relative to the first housing from the stowed configuration and the deployed configuration ([0087], insertion drive 330 moves syringe 260 from home position to injection position).
Denzer does not disclose wherein the user input comprises a first configuration at a distal position and a second configuration at a position proximal to the distal position prior to actuation, in the first configuration the drive mechanism is configured to inhibit actuation of the user input, and in the second configuration the drive mechanism is configured to permit actuation of the user input, wherein the drive mechanism includes a guide, and the user input includes one or more hook members that engage the guide when the user input is in the first configuration.
However, Grimoldby teaches wherein the user input comprises a first configuration at a distal position (FIG. 21(a)) and a second configuration at a position proximal to the distal position prior to actuation (FIG. 22(a)), in the first configuration the drive mechanism is configured to inhibit actuation of the user input ([0196], stowed position), and in the second configuration the drive mechanism is configured to permit actuation of the user input ([0199], working position), wherein the drive mechanism includes a guide (guide wall 150), and the user input includes one or more hook members (locking finger 214) that engage the guide when the user input is in the first configuration (FIG. 21(a), [0196]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion and user input disclosed by Denzer to have specific configurations of the user input corresponding to when and when not the device can be activated as taught by Grimoldby in order to provide a visual indication to the user that the trigger button has been unlocked and that the device is ready for injection ([0199]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive mechanism and user input disclosed by Denzer to have a guide and hook engagement system as taught by Grimoldby in order to provide a simple and reliable means for positively blocking movement of the trigger component ([0011]).
Regarding claim 17, in the modified device of Denzer, Denzer discloses the disposable portion further comprises a syringe assembly that contains the therapeutic agent to be dispensed ([0085], pharmaceutical product 267).
Regarding claim 18, in the modified device of Denzer, Denzer discloses the user input is actuatable by a user ([0109], “pressing the start button”) to actuate a rotary actuator of the drive mechanism ([0111], insertion drive motor 331).
Denzer does not disclose wherein in the first configuration a follower of a drive mechanism is configured to contact the user input to inhibit actuation of the user input, and in the second configuration the follower is disposed apart from and permits actuation of the user input. However, Grimoldby teaches wherein in the first configuration a follower of a drive mechanism (interlock component 250) is configured to contact the user input to inhibit actuation of the user input, and in the second configuration the follower is disposed apart from and permits actuation of the user input ([0196]-[0198], movement of the interlock component 250 moves the trigger button 200 proximally). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive mechanism of the modified device disclosed by Denzer to include a follower which permits activation of the device as taught by Grimoldby in order that accidental or premature operation of the device is avoided ([0011]) prior to movement of the follower.
Regarding claim 19, in the modified device of Denzer, Denzer discloses the disposable portion further comprises a syringe assembly having a needle (syringe 260 having injection needle 265), and in the deployed configuration the needle is at least partially extended distally ([0087], “an injection position, where the injection needle 265 is in a needle extended position that allows it to penetrate the skin at the injection site”) from a distal end of the reusable portion housing (FIG. 6A-6D, proximal wall 318), wherein the reusable portion further comprises a skin detection sensor (skin sensor 380) configured to detect contact between the distal end of the second housing and a skin of a subject (FIG. 8, [0102], “The skin sensor 380 determines when the proximal end wall 318 of the autoinjector 300 touches or contacts skin without the need to provide downward pressure on the injection-site area.”), wherein the reusable portion is configured to inhibit actuation of the user input when the skin detection sensor does not detect contact between the distal end of the reusable portion housing and the skin of the subject ([0103], “no-touch” state), and the reusable portion is configured to permit actuation of the user input when the skin detection sensor detects contact between the distal end of the reusable portion housing and the skin of the subject ([0103], “touch OK” state).
Regarding claim 20, in the modified device of Denzer, Denzer discloses the disposable portion further comprises a needle shield (needle shield 266) detachably coupled to the syringe assembly ([0094], "removing the needle shield 266 and uncovering the injection needle 265") to obscure the needle when the disposable portion is in the stowed configuration (FIG. 4F, [0089]).
Denzer does not disclose the reusable portion further comprising a needle shield presence sensor configured to detect the needle shield, the reusable portion configured to inhibit actuation of the user input when the needle shield presence sensor detects that the needle shield is coupled to the syringe assembly, and the reusable portion is configured to permit actuation of the user input when the needle shield presence sensor detects that the needle shield is detached from the syringe assembly. However, Henderson teaches the reusable portion further comprising a needle shield presence sensor ([0030], first sensor) configured to detect the needle shield ([0030], “a first sensor may transmit a signal to the data storage device 400 when the needle sheath 110 is removed”), the reusable portion configured to inhibit actuation of the user input when the needle shield presence sensor detects that the needle shield is coupled to the syringe assembly (first sensor would transfer data to microprocessor disclosed by Denzer to inhibit actuation), and the reusable portion is configured to permit actuation of the user input when the needle shield presence sensor detects that the needle shield is detached from the syringe assembly (first sensor would transfer data to microprocessor disclosed by Denzer to permit actuation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion of the modified device disclosed by Denzer to incorporate a needle shield presence sensor as taught by Henderson in order to measure or determine functional parameters of the disposable or reusable portions of the device ([0030]), and make a decision if activation is allowable.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Denzer in view of Grimoldby as applied to claim 14 above, and further in view of Atterbury.
Regarding claim 15, in the modified device of Denzer, Denzer does not disclose the drive mechanism includes a follower rotatable relative to the guide, and a portion of the follower engages the one or more hook members of the user input during rotation to release the one or more hook members from the guide, thereby allowing the user input to move to the second configuration.
However, Grimoldby teaches the drive mechanism includes a follower (interlock component 250), and a portion of the follower engages the one or more hook members of the user input during rotation to release the one or more hook members from the guide ([0198], “proximal movement of the interlock component 250 pushes the locking fingers 214, and therefore the trigger button 200, in the proximal direction”), thereby allowing the user input to move to the second configuration ([0196]-[0198], movement of the interlock component 250 moves the trigger button 200 proximally). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive mechanism of the modified device disclosed by Denzer to include a follower which permits activation of the device by interacting with hook members as taught by Grimoldby in order to allow controlled displacement of the trigger component to the firing position ([0061]).
Denzer in view of Grimoldby still does not disclose the follower being a rotatable relative to the guide. However, Atterbury teaches the follower being a rotatable relative to the guide (FIG. 43, [0086], actuator shuttle 224 rotates relative to and activates a pressure generating actuator 226 to begin injection). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the follower taught by Grimoldby in the drive mechanism of the modified device disclosed by Denzer to rotate the follower as taught by Atterbury in order that the device move from inhibiting actuation to permitting actuation ([0007]-[0008]). Also, by allowing the device components to operate in more than one direction, the device is able to be more compact while using all necessary parts for proper injection.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Denzer in view of Grimoldby and Atterbury as applied to claim 15 above, and further in view of Radmer.
Regarding claim 16, in the modified device of Denzer, Denzer discloses when the one or more hook members are released from the guide (Grimoldby - [0198], “proximal movement of the interlock component 250 pushes the locking fingers 214, and therefore the trigger button 200, in the proximal direction”).
Denzer in view of Grimoldby and Atterbury still does not disclose a spring provides a biasing force to proximally move the user input to the second configuration. However, Radmer teaches a spring (helical compression spring 25) provides a biasing force to proximally move the user input to the second configuration ([0047], “The sliding element 35 will rotate because of the freedom in the housing 20 and the torque generated by the pretensioned helical compression spring 25. Furthermore, the injection button 5 is rotated and axially translated, in response to the axial displacement and rotation of the sliding element 35, from an unloaded or unprepared state indicated by its non-protruding placement inside the housing 20 of injection device to a loaded or prepared state”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive mechanism of the modified device disclosed by Denzer to include a spring which supports movement of the user input as taught by Radmer in order to store axial spring force and a torque for subsequent movement ([0046], [0047], [0050]), both proximally and distally, of the user input.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Plumptre (WIPO International Publication No. WO 2017/207478 A2) is considered relevant prior art in regards to an activator button is hooked legs for connected to a drug delivery device.
Flather et al. (United States Patent Application Publication No. US 2020/0121859 A1) is considered relevant prior art in regards to a syringe with hook members on the user input.
Bar El et al. (United States Patent No. US 10,149,943 B2) is considered relevant prior art in regards to a drug delivery device with rotational proximal end and a drive mechanism.
Hansen (WIPO International Publication No. WO 2017/114934 A1) is considered relevant prior art in regards to an auto injector with rotational bias being provided by an actuator and a needle shield.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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