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 .
Response to Amendments
The Amendment filed 12/22/2025 has been entered.
Claims 6 and 8 have been cancelled.
Claims 1-5, 7, and 9-22 remain pending in the application.
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.
(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.
Claims 1, 3-5, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schader et al. (U.S. Publication No. 2018/0361069 ), hereinafter Schader.
Regarding claim 1, Schader discloses a medicament injector (device 10; the Examiner notes all structural elements in the claims can be found in FIGS. 9-11. Any other figure will be stated otherwise.) comprising:
an applicator (housing 11) including a cartridge-accepting receptacle (cartridge holder 13) and including at least one barrier member (needle 15 and needle holder 36) having a passageway extending therethrough; and
an interchangeable cartridge (cartridge 14) shaped to receive or contain a medicament within an interior thereof “cartridge 14 is in the form of a substantially cylindrical container 28 which stores the liquid medicament”, [0058]), the at least one barrier member having a closed position in which access to the medicament via the applicator is inhibited (the Examiner notes the closed position can be any position when septum 31 is unpierced by needle 15), and the at least one barrier member being moveable from the closed position to an open position, in which the medicament is accessible via the applicator when the cartridge is inserted into the cartridge-accepting receptacle (the Examiner notes the open position can be any position when septum 31 is pierced by needle 15), wherein the at least one barrier member (holder 36) is shaped to block a needle (needle 15) from extending therethrough in the closed position (storage position, see [0061]) thereof and wherein the at least one barrier member is shaped to receive a needle therethrouqh via the passageway (septum 31)in the open position thereof.
Regarding claim 3, Schader discloses the claimed invention as discussed above concerning the rejection of claim 1, and Schader further discloses including one or more gears (gear section 40 to drive the needle holder 36) via which the at least one barrier member moves from the closed position to the open position and vice versa (See [0074]).
Regarding claim 4, Schader discloses the claimed invention as discussed above concerning the rejection of claim 1, and Schader further discloses wherein the applicator (housing 11) includes a first of teeth and a gear (teeth 24 of the row 23, see [0074]; the Examiner notes row 23 functions as a linear gear) and wherein the at least one barrier member includes a second of the teeth and the gear (teeth 45 of the gear section 40), whereby insertion of the cartridge into the applicator causes the teeth and the gear to engage each other, with the at least one barrier member moving from the closed position to the open position (“an actuating mechanism 39 for pivoting the needle 15 between the storage position and the use position. In the present embodiment, the actuating mechanism 39 comprises the row 23 of teeth 24 of the cap 12 and a gear section 40 comprising a plurality of teeth 45 and located along an edge 41 of the second end 38 of the needle holder 36.”, [0061]).
Regarding claim 5, Schader discloses the claimed invention as discussed above concerning the rejection of claim 1, and Schader further discloses wherein the at least one barrier member includes a lever (projection 43 which engages recess 44 of holder 36) which engages with the applicator when the cartridge is inserted into the applicator and causes the at least one barrier member to move from the closed position to the open position (“locking mechanism 42 includes a first locking element in the form of a projection 43 protruding from the cartridge holder 13, and a second locking element in the form of a recess 44 formed in the needle holder 36. The projection 43 and the recess 44 are configured to cooperate to form a snap-fit connection to releasably lock the needle 15 in the use position.”, [0062]).
Regarding claim 13, Schader discloses a medicament injector (device 10; the Examiner notes all structural elements in the claims can be found in FIGS. 9-11. Any other figure will be stated otherwise.) comprising:
an applicator (housing 11) including a cartridge-accepting receptacle (cartridge holder 13) and at least one barrier member (needle 15 and needle holder 36);
an actuator via which the at least one barrier member is actuated (actuating mechanism, see [0022]); and
an interchangeable cartridge (cartridge 14) shaped to receive or contain a medicament within an interior thereof “cartridge 14 is in the form of a substantially cylindrical container 28 which stores the liquid medicament”, [0058]), the at least one barrier member having a closed position in which access to the medicament via the applicator is inhibited (the Examiner notes the closed position can be any position when septum 31 is unpierced by needle 15), and the at least one barrier member being moveable from the closed position to an open position, in which the medicament is accessible via the applicator when the cartridge is inserted into the cartridge-accepting receptacle (the Examiner notes the open position can be any position when septum 31 is pierced by needle 15), wherein the sterility of the at least one barrier member is preserved throughout the closed and open positions therof (see sterile packaging in [0004]).
Regarding claim 14, Schader discloses the claimed invention as discussed above concerning the rejection of claim 13, and Schader further discloses wherein the at least one barrier member (needle 15 and needle holder 36) is configured to move back to the closed position when the cartridge is removed from the cartridge-accepting receptacle (the Examiner notes the closed position can be any position when septum 31 is unpierced by needle 15).
Regarding claim 15, Schader discloses the claimed invention as discussed above concerning the rejection of claim 13, and Schader further discloses wherein the actuator comprises one or more gears (“the actuating mechanism 39 comprises the row 23 of teeth 24 of the cap 12 and a gear section 40 comprising a plurality of teeth 45 and located along an edge 41 of the second end 38 of the needle holder 36.”, [0061]).
Regarding claim 16, Schader discloses the claimed invention as discussed above concerning the rejection of claim 13, and Schader further discloses wherein the at least one barrier member (needle 15 and needle holder 36) includes a first of a linear gear and a circular gear (gear section 40) and wherein the actuator includes a second of the linear gear (row 23) and the circular gear, whereby insertion of the cartridge into the applicator causes the gears to engage with each other and causes the at least one barrier member to move from the closed position to the open position (see FIG. 2B).
Regarding claim 17, Schader discloses the claimed invention as discussed above concerning the rejection of claim 13, and Schader further discloses wherein the actuator comprises a lever (projection 43 which engages recess 44 of holder 36).
Regarding claim 18, Schader discloses the claimed invention as discussed above concerning the rejection of claim 13, and Schader further discloses including a needle assembly (“needle 15 comprises a proximal end 33, a distal end 34, and an intermediate section 35 joining the proximal end 33 and the distal end 34 together.”, [0060]) selectively in fluid communication with the medicament when the cartridge is inserted into the applicator, the needle assembly coupling to and being resiliently biased outwards from the cartridge-accepting receptacle (see FIG. 2B).
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blundred et al. (U.S. Publication No. 2016/0184519), hereinafter Blundred.
Regarding claim 19, Blundred discloses a medicament injector (drug delivery device 10; the Examiner notes all structural elements in the claims can be found in FIGS. 9-11. Any other figure will be stated otherwise.) comprising:
an applicator (dispensing interface 200) including a cartridge-accepting receptacle (cartridge holder 40)
at least one barrier member (valve seal 260, seated between the first inner body 220 and the second inner body 230) which is both rigid and reversible (see [0116]); and
an interchangeable cartridge (first and second cartridges 90 and 100) shaped to receive or contain a medicament (medicaments 92 and 102) within an interior thereof, the at least one barrier member having a pre-injection mode in which access to the medicament via the applicator is inhibited (“valve 260 comprises a first non-return valve 262 and a second non-return valve 268. As such, the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264. Similarly, the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266.”, [0116]; the Examiner notes when cartridge is not inserted and pierced that the lack of fluid pathway is sufficient to teach a closed position where medicament is inhibited), and the at least one barrier member being moveable from the pre-injection mode to an injection mode, in which the medicament is accessible via the applicator when the cartridge is inserted into the cartridge-accepting receptacle (“when the interface 200 is first mounted over the distal end of the cartridge holder 40, the proximal piercing end 244 of the first piercing needle 240 pierces the septum of the first cartridge 90 and thereby resides in fluid communication with the primary medicament 92 of the first cartridge 90”, [0122]),
and the at least one barrier member being configured to move back to the pre-injection mode when the cartridge is removed from the cartridge-accepting receptacle (“When the cartridge is empty, the piston rod is retracted completely inside the main body 14, so that the empty cartridge can be removed and a new cartridge can be inserted”, [0090]; the Examiner notes the retraction of the piston rod removes septum and eliminating fluid connection thereby teaching the barrier member moving to a closed position inhibiting access to medicament).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 2, 6-12, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Blundred et al. (U.S. Publication No. 2016/0184519), hereinafter Blundred, and further in view of Schader et al. (U.S. Publication No. 2018/0361069 ), hereinafter Schader.
Regarding claim 1, Blundred discloses a medicament injector (drug delivery device 10; the Examiner notes all structural elements in the claims can be found in FIGS. 9-11. Any other figure will be stated otherwise.) comprising:
an applicator (dispensing interface 200) including a cartridge-accepting receptacle (cartridge holder 40) and including at least one barrier member (valve seal 260, seated between the first inner body 220 and the second inner body 230) having a passageway extending therethrough (“valve seal 260 may be provided within a cavity 231 defined by the second inner body 230, so as to form a holding chamber 280”, [0116]; “a fluid communication may be created between the first needle 240 and the second needle 250”, [0120]; see FIG. 11); and
an interchangeable cartridge (first and second cartridges 90 and 100) shaped to receive or contain a medicament (medicaments 92 and 102) within an interior thereof, the at least one barrier member having a closed position in which access to the medicament via the applicator is inhibited (“valve 260 comprises a first non-return valve 262 and a second non-return valve 268. As such, the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264. Similarly, the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266.”, [0116]; the Examiner notes when cartridge is not inserted and pierced that the lack of fluid pathway is sufficient to teach a closed position where medicament is inhibited), and the at least one barrier member being moveable from the closed position to an open position, in which the medicament is accessible via the applicator when the cartridge is inserted into the cartridge-accepting receptacle (“when the interface 200 is first mounted over the distal end of the cartridge holder 40, the proximal piercing end 244 of the first piercing needle 240 pierces the septum of the first cartridge 90 and thereby resides in fluid communication with the primary medicament 92 of the first cartridge 90”, [0122]), however, Blundred does not expressly state wherein the at least one barrier member is shaped to block a needle from extending therethrough in the closed position thereof and wherein the at least one barrier member is shaped to receive a needle therethrouqh via the passageway in the open position thereof.
Schader teaches a medicament injection device (Abstract) wherein the at least one barrier member (holder 36) is shaped to block a needle (needle 15) from extending therethrough in the closed position (storage position, see [0061]) thereof and wherein the at least one barrier member is shaped to receive a needle therethrouqh via the passageway (septum 31)in the open position thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Blundred to include at least one barrier member shaped to block a needle from extending therethrough in the closed position thereof and wherein the at least one barrier member is shaped to receive a needle therethrouqh via the passageway in the open position thereof. Doing so provides an actuating mechanism for pivoting the needle, as taught by Schader (see [0061]).
Regarding claim 2, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches wherein the at least one barrier member is configured to move back to the closed position when the cartridge is removed from the cartridge-accepting receptacle (“When the cartridge is empty, the piston rod is retracted completely inside the main body 14, so that the empty cartridge can be removed and a new cartridge can be inserted”, [0090]; the Examiner notes the retraction of the piston rod removes septum and eliminating fluid connection thereby teaching the barrier member moving to a closed position inhibiting access to medicament).
Regarding claim 7, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches wherein the applicator (dispensing interface 200) includes a needle (see FIG. 11; needles 240 and 250) and a depressor (piston rod, see [0090]), whereby when the cartridge is inserted into the cartridge- accepting receptacle, actuation of the depressor causes the medicament to be in fluid communication with the needle (“a piston rod may push the bung of a cartridge forward a pre-determined amount for a single dose of medicament”, [0090]).
Regarding claim 9, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches wherein the applicator (interface 200) includes a patient-facing portion adapted for variable injection mechanisms including: IM (intramuscular) needle delivery, IV (intravenous) fluid connection delivery with a standard IV tubing and Luer LockTM mechanism, and/or IN (intranasal) medicament atomizer delivery (“a double-ended needle assembly. This provides a combination drug injection system that, from a user's perspective, achieves drug delivery in a manner that closely matches the currently available injection devices that use standard needle assemblies.”, [0009]).
Regarding claim 10, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches wherein once the cartridge is inserted into the cartridge-accepting receptacle, delivery of the medicament is determined by: a plunger mechanism where a partial or complete dose of the medicament is delivered (“According to an embodiment of the apparatus the apparatus comprises a piston rod for expelling a substance from a cartridge within the cartridge holder ”, [0054]); a spring-loaded delivery system where an entire volume/dosage of the medicament in a pre-filled said cartridge is delivered; and/or a pneumatic delivery system where the entire volume/dosage of the medicament in the pre-filled said cartridge is delivered.
Regarding claim 11, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches an interchangeable cartridge (first and second cartridges 90 and 100) as claimed in claim 1 shaped to be received within a cartridge-receiving receptacle (cartridge holder 40) of a medicament injector (device 10).
Regarding claim 12, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches a kit comprising a plurality of interchangeable cartridges and the medicament injector as claimed in claim 1 (“The medical device can be an injector, for example a hand-held injector, especially a pen-type injector, that is an injector of the kind that provides for administration by injection of medicinal products from one or more multidose cartridges.”, [0002]; see [0025-0026; 0034]).
Regarding claim 20, Blundred discloses a medicament injector (drug delivery device 10; the Examiner notes all structural elements in the claims can be found in FIGS. 9-11. Any other figure will be stated otherwise.) comprising:
an applicator (dispensing interface 200) including a cartridge-accepting receptacle (cartridge holder 40);
a plurality of interchangeable cartridges (first and second cartridges 90 and 100) containing pre-filled amounts of one or more medicaments(medicaments 92 and 102) therewithin; and
a reversible barrier mechanism (valve seal 260, seated between the first inner body 220 and the second inner body 230) which inhibits access to the one or more medicaments via a needle (needles 240 and 250) until a selected one of said cartridges is inserted into the cartridge- accepting receptacle (“valve 260 comprises a first non-return valve 262 and a second non-return valve 268. As such, the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264. Similarly, the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266.”, [0116]; the Examiner notes when cartridge is not inserted and pierced that the lack of fluid pathway is sufficient to teach a closed position where medicament is inhibited), however, Blundred does not expressly state wherein the reversible barrier mechanism is moveable from a needle-blocking to an injection-enabling position independent of medicament flow.
Schader teaches a medicament injection device (Abstract) wherein the reversible barrier mechanism (holder 36) is moveable from a needle-blocking (storage position, see [0061]) to an injection-enabling position (use position, see [0061]) independent of medicament flow.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Blundred wherein the reversible barrier mechanism is moveable from a needle-blocking to an injection-enabling position independent of medicament flow. Doing so provides an actuating mechanism for pivoting the needle, as taught by Schader (see [0061]).
Regarding claim 21, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 1, and Blundred further teaches wherein the applicator includes said at least one barrier member (see FIG. 9).
Regarding claim 22, Blundred in view of Shader teaches the claimed invention as discussed above concerning the rejection of claim 21, and Blundred further teaches wherein the cartridge includes at least one barrier member (valve seal 260) having a passageway extending therethrough, wherein the at least one barrier member of the cartridge has a closed position in which access to the medicament via the applicator is inhibited (“valve 260 comprises a first non-return valve 262 and a second non-return valve 268. As such, the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264. Similarly, the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266.”, [0116]; the Examiner notes when cartridge is not inserted and pierced that the lack of fluid pathway is sufficient to teach a closed position where medicament is inhibited), and wherein the at least one barrier member of the cartridge is moveable from the closed position thereof to an open position, in which the medicament is accessible via the applicator when the cartridge is inserted into the cartridge-accepting receptacle (“when the interface 200 is first mounted over the distal end of the cartridge holder 40, the proximal piercing end 244 of the first piercing needle 240 pierces the septum of the first cartridge 90 and thereby resides in fluid communication with the primary medicament 92 of the first cartridge 90”, [0122]), however, Blundred does not expressly state wherein the at least one barrier member of the cartridge is shaped to block the needle from extending therethrough in the closed position thereof and wherein the at least one barrier member of the cartridge is shaped to receive the needle therethrough via the passageway in the open position thereof.
Schader teaches a medicament injection device (Abstract) wherein the at least one barrier member (holder 36) of the cartridge is shaped to block a needle (needle 15) from extending therethrough in the closed position (storage position, see [0061]) thereof and wherein the at least one barrier member of the cartridge is shaped to receive a needle therethrouqh via the passageway (septum 31)in the open position thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Blundred to include at least one barrier member of the cartridge shaped to block a needle from extending therethrough in the closed position thereof and wherein the at least one barrier member of the cartridge is shaped to receive a needle therethrouqh via the passageway in the open position thereof. Doing so provides an actuating mechanism for pivoting the needle, as taught by Schader (see [0061]).
Response to Arguments
Applicant’s arguments, see Remarks filed 12/22/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102(a)(1) as being unpatentable over Blundred (U.S. Publication No. 2016/0184519) or Schader (U.S. Publication No. 2018/0361069) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 as being unpatentable over Blundred (U.S. Publication No. 2016/0184519), further in view of Schader (U.S. Publication No. 2018/0361069).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
04/30/2026/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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