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 Amendment
The Amendment filed 5/21/2026 has been entered. Claims 17 and 19-44 remain pending in the application. Applicant’s amendments to the Specification, Drawings and Claims have overcome each and every objection, 112(a), 112(d) and 112(b) rejections previously set forth in the Non-Final Office Action mailed 2/24/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 19-23, 25-29, 31-39 and 41-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 2013/0310757 A1).
Regarding claim 17, Brereton teaches a drug delivery device 1 (figure 1A) comprising:
a housing 7 adapted to receive a container 3 comprising a piston 6 and containing a dose of a drug “M”;
an audible and/or tactile indicator 28 configured to provide an indication to a user at or near an end of a delivery of the drug (paragraph 0183, lines 9-12);
a plunger (integrated structure formed by elements 9, 11 and 17) selected from a group of plungers (all the varying lengths of plungers that could be manufactured to insert inside element 3) having different lengths, each plunger of the group of plungers configured to be slidably disposed in the housing 7 and adapted to drive the piston 6 for delivering the drug; and
a trigger mechanism 31 (figures 26A, 26B) arranged between the audible and/or tactile indicator 28, 21 and the plunger 9, 11, 17, the trigger mechanism 31 (figures 26A, 26B) configured to couple with any plunger of the group of plungers to activate the audible and/or tactile indicator (see figures 14A-14C).
Regarding claim 19, Brereton teaches further comprising a drive spring 8 preloaded between the housing 7 and the plunger 9, 11, 17 to urge the plunger in a distal direction (paragraph 0158, lines 10-12).
Regarding claim 20, Brereton teaches wherein the trigger mechanism 31 is configured (i) to support the audible and/or tactile indicator 28 in an initial state of the drug delivery device (figure 14A) and during the delivery of the drug (paragraph 0163, lines 12-20) and (ii) to couple with any plunger (if only the length of element 9 is varied by keeping elements 11 and 17 same, plunger of any length would work in the device) of the group of plungers to activate (paragraph 0163, lines 20-31) the audible and/or tactile indicator 28 at or near the end of the delivery of the drug.
Regarding claim 21, Brereton teaches wherein upon activating the audible and/or tactile indicator 28, the audible and/or tactile indicator 28 disengages from a support 30 of the trigger mechanism 31.
Following is the first interpretation of claim 22 under Brereton
Regarding claim 22, Brereton teaches wherein the trigger mechanism 31 comprises at least one structure 28.1, 28.3, 30.1 resiliently abutting the plunger 9, 11, 17.
Following is the rejection of claim 23 under first interpretation of claim 22
Regarding claim 23, Brereton teaches wherein the at least one structure 30.1 protrudes from an indicator holder 30 towards the plunger 9, 11, 17.
Following is the second interpretation of claim 22 under Brereton
Regarding claim 22, Brereton teaches wherein the trigger mechanism 31 comprises at least one structure 30, 28.1, 28.3, 30.1 resiliently abutting the plunger 9, 11, 17.
Following is the rejection of claims 25, 26, 27, 28, 29 under both interpretation of claim 22
Regarding claim 25, Brereton teaches wherein the at least one structure comprises an inclined surface (surfaces of elements 28.3, 30.1).
Regarding claim 26, Brereton teaches wherein the at least one structure comprises a proximal inclined end (see “PE” in figure 14B below) and a distal stepped edge (see “DE” in figure 14B below).
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Regarding claim 27, Brereton teaches wherein the at least one structure 28.3, 30.1 comprises at least one fin or rib (elements 28.3 and 30.1 can be construed as rib or fin).
Regarding claim 28, Brereton teaches wherein each plunger 9, 11, 17 of the group of plungers comprises at least one cut-out (cut-out inside element 17 to accommodate elements 28.1, 28.3, 30 and 30.1) adapted to receive the at least one structure 30, 28.1, 28.3, 30.1 at or near the end of the delivery of the drug.
Regarding claim 29, Brereton teaches wherein the at least one cut-out comprises at least one of a lateral inclined edge or a distal stepped edge (see “D” in figure 14B above).
Regarding claim 31, Brereton teaches further comprising a needle sleeve 2 telescopically (paragraph 0138, lines 14-16) coupled to the housing 7.
Regarding claim 32, Brereton teaches wherein the drug delivery device is an auto-injector or pen-injector (see figure 1A).
Regarding claim 33, Brereton teaches further comprising the container 3 containing the dose of the drug “M”, wherein the container 3 is disposed in the housing 7.
Regarding claim 34, Brereton teaches a drug delivery device set 1 (figure 1A) comprising:
a housing 7 adapted to receive a container 3 comprising a piston 6 and containing a first dose of a drug “M” or a second dose of the drug “M”;
a plunger (integrated structure formed by elements 9, 11 and 17) having a first length (total length of integrated structure formed by elements 9, 11 and 17) or a second length that is different that the first length, the plunger configured to be slidably disposed in the housing 7 and adapted to drive the piston 6 for delivering the first dose or the second dose of the drug;
an audible and/or tactile indicator 28 configured to provide an indication to a user at or near an end of delivery of the drug (paragraph 0183, lines 9-12); and
a trigger mechanism 31 (figures 26A, 26B) configured to be arranged between the audible and/or tactile indicator 28, 21 and the plunger 9, 11, 17 when the plunger is slidably disposed in the housing,
wherein the trigger mechanism 31 is configured to couple with the plunger to activate the audible and/or tactile indicator at or near an end of delivery of the first dose of the drug or near an end of delivery of the second dose of the drug independent of plunger length (see figures 14A-14C).
Regarding claim 35, Brereton teaches wherein the housing 7 comprises the container 3 and is disposed in the drug delivery device.
Regarding claim 36, Brereton teaches wherein the trigger mechanism 31 comprises at least one structure 7.21 configured to resiliently abut the plunger when the plunger is slidably disposed in the housing 7 and the plunger 9, 11, 17 comprises at least one cut-out (portion of element 9 where element 7.21 gets in contact with element 9 as shown in figure 26B) adapted receive the at least one structure at or near the end of delivery of the drug.
Regarding claim 37, Brereton teaches further comprising the container 3 containing the first dose of the drug “M” or the second dose of the drug “M”, wherein the container 3 is disposed in the housing 7.
Regarding claim 38, Brereton teaches a method of assembling a drug delivery device 1 (figure 1A), the method comprising:
disposing a container 3 in a housing 7 of the drug delivery device, the container 3 containing a dose of a drug “M”;
disposing a plunger (integrated structure formed by elements 9, 11 and 17) selected from a group of plungers having different lengths (all the varying lengths of plungers that could be manufactured to insert inside element 3) in the housing, each plunger of the group of plungers comprising at least one cut-out (cut-out inside element 17 to accommodate elements 28.1, 28.3, 30 and 30.1) adapted to receive at least one structure 28.1, 28.3, 30, 30.1 at or near an end of a delivery of the drug (paragraph 0163, lines 12-35, “state A until immediately prior to the end of injection with the stopper having almost bottomed out” indicates the structures 28.1, 28.3, 30, 30.1 are staying in the cut-out near the end of the delivery of the drug); and
disposing a trigger mechanism 31 (figures 26A, 26B) in the drug delivery device, the trigger mechanism 31 (figures 26A, 26B) configured to generate, by an audible and/or tactile indicator 28, 7.21 of the drug delivery device, an audible and/or tactile indication for any plunger of the group of plungers (paragraph 0163, lines 20-35, paragraph 0189, lines 4-8).
Regarding claim 39, Brereton teaches a method of delivering a drug from a drug delivery device 1 (figure 1A), the method comprising:
moving (paragraph 0158, lines 10-16) a plunger 9, 11, 17 of the drug delivery device 1 relative to a housing of the drug delivery device 1 to (i) deliver a dose “M” of the drug from a container 3 of the drug delivery device 1 and (ii) to trigger generation (paragraph 0163, lines 20-35) of an audible and/or tactile indication 28 at or near an end of the delivery of the dose of the drug by an audible and/or tactile indicator of the drug delivery device,
wherein the plunger 9, 11, 17 is selected from a group of plungers having different lengths, and each plunger of the group of plungers is configured to be slidably disposed in the housing 3 and sized such that the audible and/or tactile indication is generated at or near the end of the delivery of the dose of the drug for any plunger of the group of plungers (paragraph 0163, lines 20-35).
Regarding claim 41, Brereton teaches wherein the audible and/or tactile indication 28 provides an indication to a user that the dose of the drug was delivered (paragraph 0163, lines 31-35).
Regarding claim 42, Brereton teaches wherein depressing a needle sleeve 2 telescopically coupled to the housing 7 against an injection site to cause the moving (paragraph 0152, paragraph 0153, lines 1-8, paragraph 0157, lines 1-6, paragraph 0158, lines 10-16, without moving element 2 with respect to element 7, element 9 cannot move since trigger button will not be active and claim does not require the plunger to be activated automatically with pressing a needle sleeve) of the plunger 9, 11, 17 relative to the housing 7 to (i) deliver the dose of the drug “M” and (ii) generate the audible and/or tactile indication (paragraph 0163, lines 31-35).
Regarding claim 43, Brereton teaches comprising firing (paragraph 0163, lines 31-35) or activating the audible and/or tactile indicator 28 to trigger the generation of audible and/or tactile indication 28.
Regarding claim 44, Brereton teaches comprising releasing the audible and/or tactile indicator 28 to trigger to generation of the audible and/or tactile indication (paragraph 0163, lines 31-35).
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 2013/0310757 A1) [Please note: claim 24 is separately presented under a rejection and claims 17 and 22 are rejected for the purpose of rejecting claim 24 under a new interpretation of Brereton in response to claim 24 amendment.]
Regarding claim 17, Brereton teaches a drug delivery device 1 (figure 1A) comprising:
a housing (structure formed by elements 7 and 2 together) adapted to receive a container 3 comprising a piston 6 and containing a dose of a drug “M”;
an audible and/or tactile indicator 28 configured to provide an indication to a user at or near an end of a delivery of the drug (paragraph 0183, lines 9-12);
a plunger (integrated structure formed by elements 9, 11 and 17) selected from a group of plungers (all the varying lengths of plungers that could be manufactured to insert inside element 3) having different lengths, each plunger of the group of plungers configured to be slidably disposed in the housing 7 and adapted to drive the piston 6 for delivering the drug; and
a trigger mechanism 31 (figures 26A, 26B) arranged between the audible and/or tactile indicator 28, 21 and the plunger 9, 11, 17, the trigger mechanism 31 (figures 26A, 26B) configured to couple with any plunger of the group of plungers to activate the audible and/or tactile indicator (see figures 14A-14C).
Regarding claim 22, Brereton teaches wherein the trigger mechanism 31 comprises at least one structure 30, 28.1, 28.3, 30.1 resiliently abutting the plunger 9, 11, 17.
Regarding claim 24, Brereton teaches wherein the at least one structure 30 protrudes from the housing 2, 7 towards the plunger, and wherein the housing 2, 7 comprises a rear case 7 and a front case 2 that are coupled to each other in an assembled state and are comprised in separate sub-assemblies (elements 2 and 7 could be kept separated so that they can be arranged in different location) to allow flexibility as to the time and location regarding final assembly.
Claim 30 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyd et al. (US 2010/0137792 A1).
Regarding claim 17, Boyd teaches a drug delivery device 1 (figure 1) comprising
a housing 4 adapted to receive a container 3 comprising a piston 5 and containing a dose of a drug “M”;
an audible and/or tactile indicator 8 (paragraph 0074, lines 3-6, element 34 is part of element 8) configured to provide an indication to a user at or near an end of a delivery of the drug;
a plunger 10 selected from a group of plungers having different lengths (lengths of element 10 could be varied to within tolerance limit and would still have group of plungers with different lengths), each plunger of the group of plungers configured to be slidably disposed in the housing 4 and adapted to drive the piston 5 for delivering the drug; and
a trigger mechanism 34 arranged between the audible and/or tactile indicator 8 and the plunger 10, the trigger mechanism 34 configured to couple with any plungers of the group of plungers to activate the audible and/or tactile indicator (paragraph 0074, lines 3-6).
Regarding claim 30, Boyd teaches wherein the trigger mechanism 34 comprises two adjacent structures (two element 34 are present) and each plunger of the group of plungers comprises two corresponding adjacent cut-outs 11’ adapted to receive the two adjacent structures 34, wherein the cut-outs extend through a wall of the plunger 10 (in order to form element 11’, walls of the element 10 is cut).
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.
Allowable Subject Matter
Claim 40 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Brereton et al. (US 2013/0310757 A1), is silent regarding wherein the at least one cut-out is arranged in the wall of the hollow plunger comprising at least the portion of the drive spring in combination with other claimed limitations of claim 40.
Response to Arguments
Applicant's arguments filed 5/21/2026 have been fully considered but they are not persuasive.
Applicant argues on page 11, lines 1-25 that Brereton fails to disclose or suggest selecting a plunger selected from a group of plungers having different lengths and a trigger mechanism arranged … configured to couple with any plunger of the group of plungers”. Furthermore, applicant argues that Brereton does not disclose or modifying the length of the plunger and therefore, claim 17 is novel over Brereton. Examiner respectfully disagrees. Claim does not positively recite to include the plungers of different lengths as a part of claimed invention. Furthermore, claim does not specify how much variance is needed in the plunger lengths therefore, if the group of plungers are manufactured with length variance within the tolerance limit of the device operation, any plunger from that group of plunger lengths is capable to be function within the drug delivery device. Furthermore, even if the length of the element 9 is reduced, the device would still be operational with the fact that small amount of drug dose will not be delivered into the patient. However, the device would still be able to operate in the manner claimed in claim 17. Therefore, Brereton discloses each and every limitation of claim 17.
Applicant argues on page 11, line 26 – page 12, line 20 that Brereton fails to disclose claimed invention of claim 34 for the same reason as disclosed in claim 17. Examiner respectfully disagrees. As explained in the response to arguments above for claim 17 and in the rejection of claim 34 in the current Office Action, claim 34 is not novel over Brereton.
Applicant argues on page 12, line 21-page 13, line 16 that the claims 38 and 39 are not novel over Brereton for the same reasons as claim 17. Examiner respectfully disagrees. As explained in the response to arguments above for claim 17, Brereton teaches each and every claimed limitation of claims 38 and 39.
Applicant’s arguments with respect to claims 24, 30 and 40 are considered but are mott because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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