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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/13/26 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 2/13/26. As directed by the amendment: claims 1, 3, 4, 13, 19, 22, 23, 25, and 26 have been amended, claims 20, 21, and 24 have been cancelled, and no new claims have been added. Thus, claims 1-19, 22, 23, 25, and 26 are presently pending in this application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6-18, 22, 23, 25, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mosebach et al. (WO 2016193348).
Regarding claim 1, Mosebach et al. discloses an audible and/or tactile indicator (structure illustrated in fig. 2-3) for use with a drug delivery device (fig. 1), the audible and/or tactile indicator comprising a resilient force member 13 configured to reside in two or more states (S1 and S2) having two or more different conformations (see S1 in fig. 2 and S2 in fig. 3),wherein in a relaxed state S1 of the two or more states, the resilient force member is relaxed in a first conformation (conformation of fig. 2), wherein in a biased state S2 of the two or more states, the resilient force member is biased to store energy in a second conformation different from the first conformation (conformation of fig. 3; pg. 12, ln. 8-17), wherein the resilient force member is configured to release stored energy to generate an audible signal when changing from the biased state into the relaxed state due to a transition from the second conformation to the first conformation (pg. 15, ln. 17-29), wherein the resilient force member is bent by a certain angle about a longitudinal axis forming a longitudinal fold with two adjacent angled wing-shaped sections (bend 13.2 with a wing angled on either side in fig. 2; pg. 3, ln. 1-4), wherein at least one of the two adjacent angled wing-shaped sections comprises a supporting tab 13.3 outwardly protruding from a long side of the at least one of the two adjacent angled wing-shaped sections (see fig. 2-3), wherein the supporting tab has at least one portion that is bent relative to the at least one of the two adjacent angled wing-shaped sections (in the embodiment specifically described in pg. 12, ln. 33-35), and wherein the at least one portion of the supporting tab has a free end (free end of 13.3) which is configured to facilitate assembly of the audible and/or tactile indicator into an autoinjector by coupling the supporting tab via a snap connection to a housing of the autoinjector (fig. 1-6; pg. 12, ln. 26 – pg. 13, ln. 7).
Regarding claim 2, Mosebach et al. discloses a notch is formed in the longitudinal fold, the notch extending transversely to the longitudinal fold (notch formed between the two wing-shaped sections as a result of the fold, see fig. 2-3).
Regarding claim 6, Mosebach et al. discloses a notch is centrically arranged in the longitudinal fold with respect to the longitudinal axis (notch formed between the two wing-shaped sections as a result of the fold, see fig. 2-3).
Regarding claim 7, Mosebach et al. discloses the supporting tab is arranged on a region of the at least one of the two adjacent angled wing-shaped sections extending between a notch (notch formed between the two wing-shaped sections as a result of the fold, see fig. 2-3) and one of two end faces of the resilient force member (see fig. 2-3).
Regarding claim 8, Mosebach et al. discloses the resilient force member is configured as a leaf spring having a longitudinal axis, the leaf spring having a rectangular shape, a square shape, or an oval shape (pg. 3, ln. 1-7; see fig. 2-3).
Regarding claim 9, Mosebach et al. discloses the resilient force member is bent about the longitudinal fold (see fig. 2-3) such that the two adjacent angled wing-shaped sections are at an angle of between 130 degrees and 160 degrees relative to each other (pg. 3, ln. 36 – pg. 4, ln. 5).
Regarding claim 10, Mosebach et al. discloses the resilient force member is configured as a bistable spring element (pg. 16, ln. 1-25).
Regarding claim 11, Mosebach et al. discloses the resilient force member is supported in the biased state in order to prevent transition into the relaxed state (pg. 41, ln. 19-20).
Regarding claim 12, Mosebach et al. discloses the resilient force member is configured to be changed from the biased state to the relaxed state by a movement of a plunger, wherein the movement of the plunger is used to displace a drug from a medicament container (pg. 15, ln. 12-29).
Regarding claim 13, Mosebach et al. discloses drug delivery device (fig. 1-6) comprising: an audible and/or tactile indicator (structure of fig. 2 and 3) comprising a resilient force member 13 configured to reside in two or more states (S1 and S2) having two or more different conformations (see S1 in fig. 2 and S2 in fig. 3),wherein in a relaxed state S1 of the two or more states, the resilient force member is relaxed in a first conformation (conformation of fig. 2), wherein in a biased state S2 of the two or more states, the resilient force member is biased to store energy in a second conformation different to the first conformation (conformation of fig. 3; pg. 12, ln. 8-17), wherein the resilient force member is configured to release stored energy to generate an audible signal when changing from the biased state into the relaxed state due to a transition from the second conformation to the first conformation (pg. 15, ln. 17-29), wherein the resilient force member is bent by a certain angle about a longitudinal axis forming a longitudinal fold with two adjacent angled wing-shaped sections (bend 13.2 with a wing angled on either side in fig. 2; pg. 3, ln. 1-4), wherein at least one of the two adjacent angled wing-shaped sections comprises a supporting tab 13.3 outwardly protruding from a long side of the at least one of the two adjacent angled wing-shaped sections (see fig. 2-3), wherein the supporting tab has at least one portion that is bent relative to the at least one of the two adjacent angled wing-shaped sections (in the embodiment specifically described in pg. 12, ln. 33-35), wherein the drug delivery device is an autoinjector (see fig. 1; pg. 9, ln. 34-35), the autoinjector comprising: a medicament container 3 comprising a medicament M; a drive spring 9 configured to provide a drive force for automated medicament delivery of the medicament (pg. 10, ln. 23-33); and a housing 2, wherein the at least one portion of the supporting tab has a free end (free end of 13.3) which facilitates assembly of the audible and/or tactile indicator into an autoiniector by coupling the supporting tab via a snap connection to the housing of the autoiniector (fig. 1-6; pg. 12, ln. 26 – pg. 13, ln. 7).
Regarding claim 14, Mosebach et al. discloses the resilient force member is configured to be changed from the biased state to the relaxed state by a movement of a plunger towards a distal position at an end of a drug delivery process (pg. 15, ln. 12-29).
Regarding claim 15, Mosebach et al. discloses the resilient force member is configured to transition from the biased state into the relaxed state when a proximal plunger section abuts a distal end face of the resilient force member (pg. 18, ln. 12-18).
Regarding claim 16, Mosebach et al. discloses a) the resilient force member is supported when the drug delivery device is in an initial state (pg. 25, ln. 21-25) and the resilient force member is unsupported when the drug delivery device is in a primed state (pg. 26, ln. 10-15), or b) wherein the resilient force member is supported when the drug delivery device is in an initial state and in a primed state (pg. 3, ln. 14-17) and a distal end face of the resilient force member is supported by a supporting protrusion arranged on a proximal region of a housing (pg. 29, ln. 4-7), or c) wherein the resilient force member is unsupported in the biased state (pg. 26, ln. 17-20).
Regarding claim 17, Mosebach et al. discloses the resilient force member is radially unsupported in the biased state (see fig. 29 and pg. 26, ln. 17-20).
Regarding claim 18, Mosebach et al. discloses in the biased state, the resilient force member is deformed to store energy (pg. 2, ln. 8-9).
Regarding claim 22, Mosebach et al. discloses the supporting tab is configured to be coupled to a rear case 2.2 of the housing of the autoinjector (pg. 3, ln. 1-7).
Regarding claim 23, Mosebach et al. discloses the audible signal is an indication of the end of a medicament delivery indicating completion of drug delivery by only one transition from the second conformation to the first conformation (pg. 2, ln. 21-33).
Regarding claim 25, Mosebach et al. discloses the housing comprises a front case 2.1 and a rear case 2.2, and wherein the supporting tab is coupled to the rear case (pg. 3, ln. 1-7).
Regarding claim 26, Mosebach et al. discloses the audible signal is an indication of the end of a medicament delivery indicating completion of drug delivery by only one transition from the second conformation to the first conformation (pg. 2, ln. 21-33).
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.
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) 3-5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosebach et al.
Regarding claims 3 and 4, Mosebach et al. discloses the two adjacent angled wing-shaped sections are angled downwards (see fig. 2), and wherein the free end is bent relative to the at least one of the two adjacent angled wing-shaped sections (in the embodiment specifically described in pg. 12, ln. 33-35), but fails to specifically disclose a specific direction (downwards/upwards) in which the free end is bent. However, such a modification would be obvious to try in that it is the result of a choice between a finite number of identified predictable solutions with reasonable expectation of success (choice of bend direction for the disclosed bend, resulting in a bend as disclosed).
Regarding claim 5, Mosebach et al. discloses the indicator as claimed, including the longitudinal fold has a bend radius (pg. 20, ln. 6-8), except for specifically disclosing the bend radius is between 1.5 mm and 2 mm. However, there is no evidence of record that establishes that changing the bend radius would result in a difference in function of the Mosebach et al. device. Further, a person having ordinary skill in the art, being faced with modifying the bend radius of Mosebach et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed bend radius. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “may” be within the claimed range or may also be outside the claimed range (pg. 11, ln. 6-11) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bend radius of Mosebach et al. to be between 1.5 mm and 2 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 19, Mosebach et al. discloses an audible and/or tactile indicator (structure of fig. 2-3) for use with a drug delivery device (fig. 1), the audible and/or tactile indicator comprising a resilient force member 13 configured to reside in two or more states (S1 and S2) having two or more different conformations (see S1 in fig. 2 and S2 in fig. 3), wherein in a relaxed state S1 of the two or more states, the resilient force member is relaxed in a first conformation (conformation of fig. 2),wherein in a biased state S2 of the two or more states, the resilient force member is biased to store energy in a second conformation different from the first conformation (conformation of fig. 3; pg. 12, ln. 8-17), wherein the resilient force member is configured to release stored energy to generate an audible signal when changing from the biased state into the relaxed state due to a transition from the second conformation to the first conformation (pg. 15, ln. 17-29), wherein the resilient force member is bent by a certain angle about a longitudinal axis forming a longitudinal fold with two adjacent angled wing-shaped sections (bend 13.2 with a wing angled on either side in fig. 2; pg. 3, ln. 1-4), wherein the resilient force member comprises spring steel (pg. 12, ln. 9), and wherein the longitudinal fold has a bend radius (pg. 20, ln. 6-8), except for specifically disclosing wherein the bend radius is between 1.59 mm and 1.61 mm. However, there is no evidence of record that establishes that changing the bend radius would result in a difference in function of the Mosebach et al. device. Further, a person having ordinary skill in the art, being faced with modifying the bend radius of Mosebach et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed bend radius. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “may” be within the claimed range or may also be outside the claimed range (pg. 11, ln. 6-11) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bend radius of Mosebach et al. to be between 1.59 mm and 1.61 mm as an obvious matter of design choice within the skill of the art.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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