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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 01/18/2023 has been considered by the Examiner.
Status of the Claims
Claims 1-20 are currently pending. Claims 1-20 are currently rejected.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “125” has been used to designate both a generator and a plunger [0068] “the generator 125 can provide a downward force on the plunger 125”.
reference character “110” has been used to designate both a sheath and a plunger [0077] “The pushing force slides the sheath 110…and activates the plunger 110”.
reference character “120” has been used to designate both [0078] “generator 120” and [0077] “plunger 120”.
reference character “865” has been used to designate both [00110] “slot 865” and [00110] “needle springs 865”.
reference character “835” has been used to designate both [00115] “…release button 835. The spring 835…”.
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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "110", “120”, and "125" have both been used to designate a plunger (see [0068] and [0077]).
Note that specific instances have been listed here, but Applicant should ensure that numbering is consistent throughout the specification. As least [0080]-[0085] and [0087]-[0088] also use reference number “120” for the plunger, while at least [0086] also use reference number “110” for the plunger”.
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. 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-20 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 10 recites the limitations “a sheath form on an injection end of the housing” and “the sheath” on line 6. From this language, it is unclear whether “a sheath form” is supposed to be a noun, or whether “form” should read “formed” and be modifying whether “a sheath” is located with regards to the rest of the limitation. Additionally, if “a sheath form” is supposed to be a noun, then “the sheath” does not have appropriate antecedent basis, thus making it unclear whether “a sheath form” and “the sheath” refer to the same structure or different structures. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 16 recites the limitation “the needle component” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the needle component” is meant to refer back to “a double-sided needle” as introduced on line 4 of claim 10, on which claim 16 depends; one or more parts of the double sided needle such as “a first pointed end”, “second pointed end” or “connective region” as introduced in claim 11, on which claim 16 also depends; whether “the needle component” is supposed to introduce an entirely new structure; or whether “the needle component” is meant to refer to a different portion of “a double-sided needle” not yet pointed out by claim 11. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 18 recites the limitation “the initiation of the injection process” on lines 7-8. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this is interpreted to read “initiation of an injection process”.
Claim 20 recites the limitation “an injection” on line 2. It is unclear whether “an injection” refers to the same “injection process” mentioned in claim 18, to part of that injection process, or to a separate process entirely. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 11-17 and 19-20 are rejected under 112b for being dependent on at least one of the claims rejected above, because dependent claims inherit the deficiencies of those claims on which they depend.
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.
Claim(s) 1, 4-5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al (US 20180339106 A1; hereafter Helmer) in view of Schmidt-Evers et al (EP 1974759 A1; hereafter Schmidt-Evers).
Regarding claim 1, Helmer discloses an injection system (device 10, fig. 3, [0054] device 10 injects a medicament into a patient’s body) comprising:
a housing (body 11 and carrier 16, fig. 3, [0063]) with a loading tray (carrier 16, fig. 3) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to accept a medication cartridge (medicament cartridge 15, fig. 3, [0063] carrier 13 receives cartridge holder 12 which contains a medicament cartridge 15);
a needle (needle 17, fig. 3, [0059]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to transport medication from the medication cartridge ([0076] needle 17 is caused to pierce a septum 37 of the medicament cartridge 15) to an injection site ([0077] injection commenced when patient’s skin is pressed against device 10 causing exposure of the distal end of the needle 17);
a sheath (needle sleeve 14, fig. 3, [0056]) formed on an injection end of the housing (body 11 and carrier 16, fig. 3) ([0056] movement of sleeve 14 in a proximal direction can permit a needle 17 to extend from distal region 120 of body 11, see fig. 1); and
a plunger (piston, mentioned in [0059]) wherein the plunger is configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) impart downward force on the medication cartridge in order to release medication in the medication cartridge ([0059] drive spring applies compressive force to proximal surface of piston which moves the piston in the distal direction such that the liquid medicament is compressed and forced out of the needle 17).
Helmer is silent to the plunger comprising at least two telescoping sections.
Schmidt-Evers, in the field of handheld injection devices, teaches a plunger (piston plunger 8, fig. 2, [0031]) comprising at least two telescoping sections (tappet sections 8a/8b/8c, fig. 2, [0031] piston plunger 8 consists of three telescopically extendable and retractable plunger sections 8a, 8b, and 8c) wherein the plunger is configured to impart downward force on the medication cartridge (insulin cartridge 2 and movable piston element 4, fig. 2a/b, [0025]) in order to release medication in the medication cartridge (fig. 2b shows the filled state and fig. 2a shows the emptied state, [0032]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the plunger of Helmer to have at least two telescoping sections as taught by Schmidt-Evers because both references deal with fluid injection from handheld devices through a needle into a patient. Schmidt-Evers motivates the modification in [0032] by noting that the overlapping tappet sections 8a/b/c can reduce the minimum length of the injection device. One would have thus been motivated to make the modification because being able to shorten the injection device would thus allow for a more compact, easy to transport injection device.
Regarding claim 4, Helmer modified by Schmidt-Evers discloses the injection system of claim 1, as described above. Helmer further discloses comprising: a sheath spring (pre-stressed spring 20, fig. 7, [0064]) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) extend and retract the sheath (needle sleeve 14, fig. 3) (note fig. 7 and [0070] arms 28 are supported on an inner surface by the needle sleeve 14 and on an outer surface by the needle holder 18; note that spring 20 pushes against distal end of needle sleeve 14) (Examiner notes that since the spring 20 is biased against the sheath/needle sleeve 14, the spring 20 is compressed when the sheath 14 is pressed against the skin and then pushes the sheath 14 back into the extended position when pressure is released, thus the spring is capable of performing the function claimed.).
Regarding claim 5, Helmer modified by Schmidt-Evers discloses the injection system of claim 1, as described above. Helmer further discloses comprising: a generator (drive spring noted in [0059]) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) impart a downward force on the plunger (piston noted in [0059]) ([0059] drive spring applies compressive force to proximal surface of piston which moves the piston in the distal direction such that the liquid medicament is compressed and forced out of the needle 17).
Regarding claim 7, Helmer modified by Schmidt-Evers discloses the injection system of claim 1, as described above. Helmer further discloses further comprising: a needle hub (needle holder 18, fig. 3, [0064]) configured to hold the needle (17, fig. 3) ([0064] The device 10 comprises a needle 17 held by a needle holder 18.).
Regarding claim 8, Helmer modified by Schmidt-Evers discloses the injection system of claim 7, as described above. Helmer further discloses further comprising: a needle switch (arm 34, fig. 8a and fig. 9, [0074]) operably connected to the needle hub (needle holder 18, fig. 8a) ([0073] arms 34 prevent premature movement of needle holder 18) wherein the needle hub (18, fig. 7) holds the needle (17, fig. 7) in alignment with the medication cartridge (15, fig. 11) (see fig. 7 which shows the needle hub 18 holding the needle in alignment with the central longitudinal axis of the injection device; see fig. 12 which shows the needle hub 18 holding the needle 17 in alignment with the medication cartridge 15 after insertion).
Regarding claim 9, Helmer modified by Schmidt-Evers discloses the injection system of claim 1 further comprising: a cartridge insertion door (exterior portion of pivotable cartridge holder 12, as seen in fig. 1, [0062]) formed in the housing (body 11, see fig. 1) that provides access to the load tray (carrier 16, fig. 3) (see fig. 4a which shows that door/cartridge holder 12 formed in housing 11 provides access to load tray 16).
Claim(s) 2-3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helmer modified by Schmidt-Evers as applied to claim 1 above, and further in view of Hansen (US 20190030248 A1; hereafter Hansen).
Regarding claim 2, Helmer modified by Schmidt-Evers discloses the injection system of claim 1, as described above. Helmer further discloses wherein the needle (17, fig. 11) further comprises: a two sided needle (needle 17 has two ends as shown in fig. 11) comprising: a first end (see fig. 11, proximal end of the needle 17 noted in [0076] as piercing a septum 37 of medicament cartridge 15); a second end (see fig. 11, distal end of needle 17 noted in [0057] as extending into patient’s body); and a body connecting the first end and second end (see body connecting the first and second end of needle 17 shown in fig. 11/12).
Examiner notes that although both needle ends of Helmer are noted as puncturing a septum or skin, the ends are not explicitly described as pointed.
Hansen, in the field of handheld injection devices, teaches wherein the needle (needle assembly 500, fig. 3a, [0108]) further comprises: a two sided needle ([0108] needle assembly 500 includes a needle cannula having a front needle 510 and a rear needle 520 respectively protruding in the distal and proximal directions from a needle hub 501) comprising: a first pointed end (pointed tip 511, fig. 3a, [0108]); a second pointed end (pointed tip 521, fig. 3a, [0108] Both front needle 510 and rear needle 520 include pointed tips 511 and 521 for respectively piercing the skin of a user and the cartridge septum 620); and a body connecting the first pointed end and second pointed end (see fig. 3a which shows that the lengths of front needle 510 and rear needle 512 which extend between and connect pointed tips 511 and 521).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the proximal and distal ends of needle 17 of Helmer modified by Schmidt-Evers to be pointed as taught by Hansen since all references deal with using needles to delivery injection fluid. One would have been motivated to make the modification because having the proximal and distal ends of needle 17 of Helmer be explicitly pointed would more easily allow the ends to puncture the seal of the cartridge and a patient’s skin, thus improving the existing structure’s ability to perform its current function.
Regarding claim 3, Helmer modified by Schmidt-Evers and Hansen discloses the injection system of claim 2, as described above, including the first and second pointed end (proximal and distal ends of needle 17 of Helmer were modified to be pointed tips as taught by Hansen). Helmer further discloses wherein one of the first pointed end and the second pointed end (see ends of needle 17 in fig. 11/12) of the two sided needle (17, fig. 11/12) is configured to pierce the medication cartridge (15, fig. 11/12) ([0076] proximal end of the needle 17 is caused to pierce a septum 37 of the medicament cartridge 15).
Regarding claim 6, Helmer modified by Schmidt-Evers discloses the injection system of claim 1, as described above. Helmer further discloses comprising: a removable safety cap (cap 12, fig. 7, [0070]) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) prevent injection (note [0057] Proximal movement of sleeve 14 by placing a distal end of sleeve 14 against a patient's body and moving body 11 in a distal direction will uncover the distal end of needle 17, note [0059] drug injection may be automated, note fig. 7 which shows that the sheath/needle shield 14 cannot be pressed against a patient’s skin until cap 12 has been removed).
Helmer as modified by Schmidt-Evers is silent to the safety cap preventing injection by preventing the plunger from imparting downward force on the medication cartridge.
Hansen, in the art of handheld injection devices, teaches a removable safety cap (removable protective cap noted in [0104] Injection device 100 may further include a removable protective cap (not shown) that attaches to a distal end of the device 100 to protect a needle end of the device 100) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) prevent the plunger (spacer member 400 and drive ram 310, fig. 3a, [0118]) from imparting downward force on the medication cartridge (medicament filled cartridge 600 and piston 630, fig. 3a, [0107]) ([0106] The protective cap, when attached to the lower housing section 220, prevents the needle shield 350 from being manipulated and thereby prevents premature triggering of the injection device 100.) ([0113] trigger element 380 moves with needle shield 350, [0122] operation of trigger element 380 releases the drive ram 310 which provides a distally directed force on the piston 630 via the spacer member 400.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Helmer modified by Schmidt-Evers to include the safety cap preventing the plunger from imparting downward force on the medication cartridge as taught by Hansen since all references deal with handheld injection devices. One would have been motivated to make the modification because preventing the plunger from imparting downward force on the medication cartridge prior to removal of the safety cap and actuation of the needle sheath ensures that no medicament in trapped in the safety cap and a full dose is present and ready to be delivered to a patient upon removal of the safety cap.
Claim(s) 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Hansen.
Regarding claim 10, Helmer discloses an auto-injector (device 10, fig. 3, [0054] device 10 injects a medicament into a patient’s body) comprising:
a medication cartridge (medicament cartridge 15, fig. 3, [0063]);
a housing (body 11 and carrier 16, fig. 3, [0063]) with a loading tray (carrier 16, fig. 3) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) accept the medication cartridge ([0063] carrier 13 receives cartridge holder 12 which contains a medicament cartridge 15);
a double-sided needle (needle 17, fig. 3 and fig. 11, distal end of needle 17 noted in [0057] as extending into patient’s body; proximal end of the needle 17 noted in [0076] as piercing a septum 37 of medicament cartridge 15) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) dispense medication from the medication cartridge ([0059] liquid medicament is compressed and forced out of the needle 17; [0076] proximal end of needle 17 is connected to medicament cartridge 15);
a sheath (needle sleeve 14, fig. 3, [0056]) form (see 112b interpretation above) on an injection end ([0056] movement of sleeve 14 in a proximal direction can permit a needle 17 to extend from distal region 120 of body 11, see fig. 1) of the housing (body 11 and carrier 16, fig. 3), wherein the sheath can be extended and retracted by a sheath spring (pre-stressed spring 20, fig. 7, [0064]);
a plunger (piston noted in [0059]); and
a generator (drive spring noted in [0059]), configured to impart a downward force on the plunger in order to transfer the force on the medication cartridge for dispensation of the medication from the medication cartridge into the needle ([0059] drive spring applies compressive force to proximal surface of piston which moves the piston in the distal direction such that the liquid medicament is compressed and forced out of the needle 17).
Helmer is silent to the plunger telescoping.
Hansen, in the art of handheld injection devices, teaches a telescoping plunger (spacer member 400 and drive ram 310, fig. 3a/4a, [0118]; [0083]-[0084] fig. 3a shows the device during fluid delivery, fig. 4a shows the device at the end of fluid delivery, note that the spacer member 400 expels fluid by telescoping through the medication cartridge 600 noted in [0107]); and
a generator (actuator 330, fig. 3a, [0118]), configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) impart a downward force on the telescoping plunger (spacer member 400 and drive ram 310, fig. 3a/4a) in order to transfer the force on the medication cartridge for dispensation of the medication from the medication cartridge into the needle ([0118] actuator 330 exerts a distally directed force on drive ram 310 which causes the piston 630 to move in a distal direction and thereby expels a dose form the cartridge 600).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Helmer to have a telescoping plunger as taught by Hansen because both references deal with injection devices. One would have been motivated to make the modification because having the plunger telescope through the inner walls of the cartridge allows for all material in the cartridge to be pushed toward the exit.
Regarding claim 11, Helmer modified by Hansen discloses the auto-injector of claim 10, as described above. Helmer further discloses wherein the double-sided needle (needle 17 has two ends as shown in fig. 11) comprises: a first end (see fig. 11, proximal end of the needle 17 noted in [0076] as piercing a septum 37 of medicament cartridge 15); a second end (see fig. 11, distal end of needle 17 noted in [0057] as extending into patient’s body); and a connective region (see body connecting the first and second end of needle 17 shown in fig. 11/12) capable of transporting medication between the first end and the second end (0059] liquid medicament is compressed and forced out of the needle 17).
Examiner notes that although both needle ends of Helmer are noted as puncturing a septum or skin, the ends are not explicitly described as pointed.
Hansen, in the field of handheld injection devices, teaches wherein the needle (needle assembly 500, fig. 3a, [0108]) further comprises: a two sided needle ([0108] needle assembly 500 includes a needle cannula having a front needle 510 and a rear needle 520 respectively protruding in the distal and proximal directions from a needle hub 501) comprising: a first pointed end (pointed tip 511, fig. 3a, [0108]); a second pointed end (pointed tip 521, fig. 3a, [0108] Both front needle 510 and rear needle 520 include pointed tips 511 and 521 for respectively piercing the skin of a user and the cartridge septum 620); and a body connecting the first pointed end and second pointed end (see fig. 3a which shows that the lengths of front needle 510 and rear needle 512 which extend between and connect pointed tips 511 and 521).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the proximal and distal ends of needle 17 of Helmer to be pointed as taught by Hansen since both references deal with using needles to delivery injection fluid. One would have been motivated to make the modification because having the proximal and distal ends of needle 17 of Helmer be explicitly pointed would more easily allow the ends to puncture the seal of the cartridge and a patient’s skin, thus improving the existing structure’s ability to perform its current function.
Regarding claim 12, Helmer modified by Hansen discloses the auto-injector of claim 11, as described above. Helmer further discloses the medication cartridge further comprises: a cap (septum 37, fig. 11, [0076]) capable of being pierced by the double-sided needle ([0076] The proximal end of the needle 17 is caused to pierce a septum 37 of the medicament cartridge 15).
Regarding claim 13, Helmer modified by Hansen discloses the auto-injector of claim 11, as described above. Helmer further discloses comprising: a removable safety cap (cap 12, fig. 7, [0070]) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) prevent injection (note [0057] Proximal movement of sleeve 14 by placing a distal end of sleeve 14 against a patient's body and moving body 11 in a distal direction will uncover the distal end of needle 17, note [0059] drug injection may be automated, note fig. 7 which shows that the sheath/needle shield 14 cannot be pressed against a patient’s skin until cap 12 has been removed).
Helmer is silent to the safety cap preventing injection by preventing the plunger from imparting downward force on the medication cartridge.
Hansen, in the art of handheld injection devices, teaches a removable safety cap (removable protective cap noted in [0104] Injection device 100 may further include a removable protective cap (not shown) that attaches to a distal end of the device 100 to protect a needle end of the device 100) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) prevent the plunger (spacer member 400 and drive ram 310, fig. 3a, [0118]) from imparting downward force on the medication cartridge (medicament filled cartridge 600 and piston 630, fig. 3a, [0107]) ([0106] The protective cap, when attached to the lower housing section 220, prevents the needle shield 350 from being manipulated and thereby prevents premature triggering of the injection device 100.) ([0113] trigger element 380 moves with needle shield 350, [0122] operation of trigger element 380 releases the drive ram 310 which provides a distally directed force on the piston 630 via the spacer member 400.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Helmer modified by Schmidt-Evers to include the safety cap preventing the plunger from imparting downward force on the medication cartridge as taught by Hansen since all references deal with handheld injection devices. One would have been motivated to make the modification because preventing the plunger from imparting downward force on the medication cartridge prior to removal of the safety cap and actuation of the needle sheath ensures that no medicament in trapped in the safety cap and a full dose is present and ready to be delivered to a patient upon removal of the safety cap.
Regarding claim 14, Helmer modified by Hansen discloses the auto-injector of claim 11, as described above. Helmer further discloses wherein the sheath (needle sleeve 14, fig. 3; note fig. 7 and [0070] arms 28 are supported on an inner surface by the needle sleeve 14 and on an outer surface by the needle holder 18) further comprises: a needle aperture (gap in needle sleeve 14 shown in fig. 7 which shows needle 17 extending through the gap in needle sleeve 14; note needle sleeve 14 is not labeled in fig. 7 but is identifiable by the description in [0070] noted above).
Regarding claim 15, Helmer modified by Hansen discloses the auto-injector of claim 11, as described above. Helmer further discloses further comprising: a first sliding stop (end stop 26, fig. 6a, [0068]); and a second sliding stop, wherein the first sliding stop and second sliding stop (distal end clip 27, fig. 6b, [0069]) restrict movement (see fig. 6a/b which show that medication cartridge 15 abuts end stop 26 and distal end clip 27 on either end which would restrict movement) of the medication cartridge (15, fig. 4a) between the first sliding stop (26, fig. 6a) and the second sliding stop ([0068] cartridge holder 12 comprises an end stop 26 to support the proximal end of the medicament cartridge 15; [0069] cartridge holder 12 comprises a distal end clip 27 to support the distal end of the medicament cartridge 15).
Regarding claim 16, Helmer modified by Hansen discloses the auto-injector of claim 11, as described above. Helmer further discloses further comprising: a needle hub (needle holder 18, fig. 3, [0064]) configured to hold the needle component (see 112b interpretation above) (17, fig. 3) ([0064] The device 10 comprises a needle 17 held by a needle holder 18.).
Regarding claim 17, Helmer modified by Hansen discloses the auto-injector of claim 16, as described above. Helmer further discloses further comprising: a needle switch (arm 34, fig. 8a and fig. 9, [0074]) operably connected to the needle hub (needle holder 18, fig. 8a) ([0073] arms 34 prevent premature movement of needle holder 18).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Helmer.
Regarding claim 18, Hansen discloses a modular injector system (injection device 100, fig. 1a/b/c, [0103]) comprising:
a dispenser assembly comprising:
an outer housing unit (top housing section 200, fig. 1a, [0103]);
a telescoping plunger (spacer member 400 and drive ram 310, fig. 3a/4a, [0118]; [0083]-[0084] fig. 3a shows the device during fluid delivery, fig. 4a shows the device at the end of fluid delivery, note that the spacer member 400 expels fluid by telescoping through the medication cartridge 600 noted in [0107]) in the outer housing unit (fig. 1a shows that the plunger section 310 is within top housing section 200);
an injection spring (actuating spring 330, fig. 1a, [0119]), configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) impart a downward force on the telescoping plunger ([0118] actuator 330 supplies distally directed force on drive ram 310 and spacer member 400); and
a protective sheath (needle shield 350 and trigger element 380, fig. 1a, [0113]) connected to the telescoping plunger (400/310) to control the initiation of the injection process (see 112b interpretation above) ([0113] needle shield 350 and trigger element 380 act as a single entity; [0122] operating the trigger element 380 allows the drive ram 310 to provide a distally directed force on the piston 630 via the spacer member 400); and
a cartridge assembly comprising:
an inner housing unit (lower housing section 220, fig. 1a shows that lower housing section 220 is within outer housing unit/top housing section 200, [0103]) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) accept a medication cartridge (medicament cartridge 600, fig. 1a, [0103] lower housing section 220 and the top housing section 200 are joined to each other to form an enclosure to accommodate a medicament cartridge 600) (see fig. 1a which shows cartridge 600 within inner housing unit/lower housing section 220); and
a needle (needle assembly 500 including needle cannula with two ends, fig. 1a, [0108] needle assembly 500 is arranged in inner housing unit/lower housing section 220) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) dispense medication from the medication cartridge (600, fig. 1a) to an injection site ([0108] needle cannula punctures septum 620 of medication cartridge 600 and skin of a user; since the needle assembly 500 includes a needle cannula connecting the medication cartridge to the skin of a user, the needle 500 is able to meet the functional limitations).
Hansen is silent to the inner housing unit having a loading tray configured to accept a medication cartridge.
Helmer, in the art of handheld injection devices, teaches an inner housing unit (carrier 16 and cartridge holder 12, fig. 3, [0063]) with a loading tray (cartridge holder 12, fig. 3) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) accept the medication cartridge ([0063] carrier 13 receives cartridge holder 12 which contains a medicament cartridge 15).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the inner housing of Hansen to incorporate the loading tray of Helmer since both references deal with injection through needles. One would have been motivated to make the modification because using the loading tray of Helmer allows the cartridge to be inserted without fully separating parts of the housing which reduces the risk of misalignment of components or any elements falling out during cartridge insertion.
Regarding claim 19, Hansen modified by Helmer discloses the modular injector system of claim 18, as described above, including wherein the dispenser assembly (see elements noted above in claim 18 which the dispenser assembly comprises) is configured to connect to the cartridge assembly (see elements in claim 18 which the cartridge assembly comprises) (Hansen: [0103] lower housing section 220 and the top housing section 200 are joined to each other to form an enclosure to accommodate a medicament cartridge 600; see also Hansen fig. 1a which shows the dispenser assembly and cartridge assembly connected).
Regarding claim 20, Hansen modified by Helmer discloses the modular injector system of claim 18, as described above. Hansen further discloses wherein the protective sheath (needle shield 350, fig. 1a, [0106]) is retracted in order to initiate an injection (see 112b interpretation above) ([0106] The injection device 100 is configured for being triggered to inject a dose when the needle shield 350 is moved from the distal extended position towards the collapsed position).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Day et al (US 20160361495 A1) - [0320] The drive train telescoping piston rod 616 is illustrated in FIG. 27 and comprises a telescope plunger 644 that is operatively coupled to an input screw 680
Curiel et al (WO 2021087607 A1) - fig. 16a, [0146], injection device 200/access device 300 has a first actuator 260 described in [0124] and a second actuator 410 described in [0136]
Quinn et al (US 20170354782 A1) - see figs. 18-20, spring driven telescoping plunger, [0153] The second plunger member 54 and the first plunger member 52 form a telescoping arrangement with the second plunger 54 configured to move axially after the first plunger member 52 moves a predetermined axial distance
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 10/16/2025