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 .
Election/Restrictions
Claims 3 and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/16/2025.
Applicant's election with traverse of Group I, drawn to claims 1, 2, 4, and 6-9 in the reply filed on 10/16/2025 is acknowledged. The traversal is on the ground(s) that: Applicant states there is only one independent claim; there is no serious search burden; and Carter does not anticipate the instant claims and there is a special technical feature. This is not found persuasive for the following reasons: Regarding the argument that there is only one independent claim, while there is only one independent claim, there are 7 embodiments of the device being claimed which were indicated in the Requirement for Restriction/Election, additionally multiple claims were drawn to specific structural requirements of certain features such as the actuator and second disengagement member, as such Applicant is required to elect a singular group to which the claims readable on the elected group will be examined. Regarding the serious search burden, as stated above there are 7 embodiments of the device being claimed, with each embodiment having different structural components that would require a different field of search, e.g. separate searches in different classifications and/or employing different search queries. Regarding the special technical feature, the species election is formed on the basis of the figures and therefore the technical features are based on their structures, not how they operate. The components of Carter cited as being the first and second disengagement members are structurally equivalent to disengagement members.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1, line 6, “locking unit” and its dependents.
Claim 1, line 10, “return unit”.
Claim 1, line 13, “blocking unit”.
Claim 1, line 14, “first disengagement member”.
Claim 1, line 16, “second disengagement member” and dependent claim 6 and 7. The recitation of “the second disengagement member” in claim 4 does not invoke 112(f) since there is the added structure of “at least one muscle wire”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrico et al. (US 20120080448 A1) and Burns et al. (US 5284133 A).
Regarding claim 1, Carrico discloses an assistance device for assisting with the use (the combination of elements blocking unit 20, blocking device 30, and control electronics 18; see figure 1-5 and [0022-0024]) of a product dispensing device for dispensing a product ([0020] liquid storage receptical 10 and applicator 12; figure 1), the product dispensing being achieved by displacement or deformation of a moving part of the dispensing device ([0020] applicator 12 comprising a nasal tube 14; figure 1) between a rest position (see figure 1) and an activation position (see figure 5a), the assistance device comprising:
- an engaging unit to the product dispensing device (see figure 1, planar structure near reference numeral 9 and 20 attaching control electronics 18 and blocking unit 20 to cylindrical housing of liquid storage receptical 10),
- a locking unit configured to prevent the dispensing of the product ([0021] blocking ring 20; figure 1-4b),
- an actuator configured to switch the locking unit from a locked position in which the locking unit prevents the dispensing of the product to an unlocked position in which the locking unit does not prevent the dispensing of the product ([0029-0030] actuator 70; figure 1-5b),
- a return unit configured to switch the locking unit from the unlocked position to the locked position, out of the activation position of the product dispensing device ([0027] This second retaining device 60 comprises a retaining element 62 which can pivot about a pivot axis 8 and comprises a retaining member 64 that likewise prevents the interlock device 40 from pivoting in the counterclockwise direction by means of a contact surface 64a. This retaining element is torque biased by a spring 66 in the clockwise direction and is therefore securely retained in its retaining position shown in FIGS. 2a and 2b. [0032] The first retaining device 50 comprising the permanent magnet 52 holds the interlock device 40 in the first position thus achieved, in the same manner as the retaining member 64, which is deflected temporarily against the force of the spring 66 when the interlock device attains the first position shown in FIGS. 5a and 5b from its second position shown in FIGS. 4a and 4b to subsequently come to again bear against the interlock device 40 by way of the contact surface 64a),
- a blocking unit (slide 32 and spring 34; figure 4a and 4b) configured to block the locking unit in the unlocked position ([0031] the slide 32 driven by the spring 34 is displaced in the direction of the arrow 6a, and thus the blocking ring 20 is pivoted about the axis 3 in such a way that it no longer prevents the applicator 12 from being depressed; figure 4a and 4b),
- a first disengagement member ([0032] sliding block guide) for disengaging the blocking unit configured to be triggered upon the activation of the product dispensing device ([0032] When the applicator 12 is depressed during this discharging operation and/or during the subsequent return stroke of the applicator 12, the slide 32 is moved back in the direction of the arrow 6b by a sliding block guide (not shown), as disclosed in DE 10 2008 064 559 A1, with the slide causing pivoting of the interlock device 40, by means of a return section 40c of the interlock device 40 counteracting the force of the spring 42, about the axis 7 in the direction of the arrow 7b; figure 5a and 5b), and
- a second disengagement member ([0025] retaining extension 40d; figure 2a-4b) for disengaging the blocking unit ([0025] The movement of the slide 32 in the direction 6a is temporarily prevented by means of an interlock device 40 and the retaining extension 40d thereof; figure 2a-4b), but is silent as to the second disengagement member is configured to be triggered independently of the activation of the product dispensing device.
However, Burns teaches an inhalation device (figure 2-5) including a locking unit (FIG. 4b illustrates a lock up arrangement 62 which may be implemented on an MDI. Specifically, an arm 64 connected to the controller 24 selectively operates a pawl 66 which has an end 68 that engages the MDI canister 10 during periods when the canister 10 should not be actuated. A gear, ratchet, pivot, or other suitable arrangement allows the pawl 66 to swing to a non-engagement position during the period when dosing is to occur so that the canister 10 may move freely towards the valve seat 18 and supply a dose to a patient; col. 10 line 52-61) wherein relocking the locking unit triggered independently of the activation of the inhalation device (To remind patients to administer the drug during the preset interval for dosing, the inhalation device is equipped with a signalling device (shown in FIG. 2). With reference to FIG. 3, step 70 provides a preset time period for actuation of the inhalation device during the time period programmed for dosing; col. 10 line 64-col. 11 line 1. A time-out feature may be provided whereby after the time period for actuation at step 70, and after providing the alarm at step 72, the non-actuation of the device will be recorded at step 74 and the inhalation device will return to its locked up position at step 36; col. 11 line 39-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the relocking of the blocking unit, specifically activation of the retaining extension to prevent movement of the slide, of Carrico to be triggered by a time-out feature, as taught by Burns in order to facilitate proper dosing during the determined time-periods while preventing wasting of medicament.
As such, the relocking of the blocking unit of Carrico, which is achieved by the retaining extension of 40d preventing movement of the slide, is triggered independently of the activation of the product dispensing device.
Regarding claim 6, modified Carrico teaches the assistance device according to claim 1, Burns teaches wherein the second disengagement unit is configured to be activated after a predetermined time has elapsed from the switching of the locking unit to the unlocked position (To remind patients to administer the drug during the preset interval for dosing, the inhalation device is equipped with a signaling device (shown in FIG. 2). With reference to FIG. 3, step 70 provides a preset time period for actuation of the inhalation device during the time period programmed for dosing; col. 10 line 64-col. 11 line 1. A time-out feature may be provided whereby after the time period for actuation at step 70, and after providing the alarm at step 72, the non-actuation of the device will be recorded at step 74 and the inhalation device will return to its locked up position at step 36; col. 11 line 39-43).
Regarding claim 8, modified Carrico teaches the assistance device according to claim 1, wherein the locking unit is configured to switch from the unlocked position to the locked position by performing a rotational movement ([0021] For the purpose of temporarily preventing a discharging operation, a blocking ring 20 is provided, which is mounted for rotation about an axis 3 oriented in the direction of actuation 2 and which, depending on its angular position, prevents the applicator 12 from being depressed by means of locating surfaces (not shown in the drawing). On the blocking ring 20, a tab 22 is provided pointing outwardly in the radial direction for displacement, as described below in more detail, for the purpose of rotating the blocking ring 2; figure 1-4b).
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrico et al. (US 20120080448 A1) and Burns et al. (US 5284133 A) as applied to claim 1 above, and further in view of Davies et al. (WO 2009003989 A1).
Regarding claim 2, modified Carrico teaches the assistance device according to claim 1, but is silent as to wherein the actuator comprises at least one muscle wire.
However, Davies teaches a medicament dispenser (title) comprising a locking mechanism controlled by an actuator wherein the actuator comprises at least one muscle wire (The locking mechanism 792 also includes an actuator which is electrically coupled to the electronic circuit. The actuator comprises a wire segment 713 which is made of a shape memory alloy (SMA), which alloy is also known in the art as a "memory metal". A suitable SMA is Flexinol™ which is made of nickel-titanium alloy (nitinol). The wire segment 713 is held in tension between two axles 715a and 715b which are fixed to the chassis 725. Each end of the wire segment is electrically coupled to the electronic circuit of the medicament dispenser using electrical wires (not shown) for instance; figure 12a-13b; pg. 32 line 15-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the actuator of Carrico to implement a shape memory alloy (SMA) made of nitinol connected to the control electronics in order to facilitate the actuation of the locking mechanism electronically as taught by Davies pg. 32 line 15-24.
Regarding claim 4, modified Carrico teaches the assistance device according to claim 1, but is silent as to wherein the second disengagement member comprises at least one muscle wire.
However, Davies teaches a medicament dispenser (title) comprising a locking mechanism actuated via at least one muscle wire (The locking mechanism 792 also includes an actuator which is electrically coupled to the electronic circuit. The actuator comprises a wire segment 713 which is made of a shape memory alloy (SMA), which alloy is also known in the art as a "memory metal". A suitable SMA is Flexinol™ which is made of nickel-titanium alloy (nitinol). The wire segment 713 is held in tension between two axles 715a and 715b which are fixed to the chassis 725. Each end of the wire segment is electrically coupled to the electronic circuit of the medicament dispenser using electrical wires (not shown) for instance; figure 12a-13b; pg. 32 line 15-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the second disengagement member of modified Carrico to implement a shape memory alloy (SMA) made of nitinol connected to the control electronics in order to facilitate the actuation of the second disengagement member electronically, as taught by Davies pg. 32 line 15-24, thereby actuating the locking mechanism in a locked position.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrico et al. (US 20120080448 A1) and Burns et al. (US 5284133 A) as applied to claim 1 above, and further in view of 5MED GMBH (DE 202016003139 U1), hereinafter 5MED.
Regarding claim 7, modified Carrico teaches the assistance device according to claim 1, but is silent as to further comprising at least one inclination sensor for measuring an inclination of the dispensing device, wherein the second disengagement member is configured to be activated when, with the locking unit being in the unlocked position, a measurement of the inclination of the dispensing device measured by the inclination sensor reaches a predetermined threshold during a predetermined period of time.
However, 5MED teaches a nasal applicator (title) comprising at least one inclination sensor for measuring an inclination of the dispensing device ([0041] at least one tilt sensor 10), wherein a locking mechanism is configured to be activated when a measurement of the inclination of the dispensing device measured by the inclination sensor reaches a predetermined threshold during a predetermined period of time ([0010] the nasal applicator has a tilt sensor for detecting the tilt of the nasal applicator and a control device for locking the dispensing doser when tilts outside a predetermined, permissible tilt range are detected and/or for activating a dosing detection device when tilts within a predetermined, permissible tilt range are detected. If the inclination of the nasal applicator deviates too much from a predetermined target orientation, the control device assumes that an irregular dispensing process would occur, so the control device can lock the dispensing dispenser to prevent a dispensing process, and/or deactivate the dose detection device so that the irregular dispensing stroke is not counted for monitoring the drug dose delivered to the user).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control electronics of modified Carrico to implement a tilt sensor for activating the locking mechanism to be moved to the locked position, and thus the second disengagement member, when a predetermined, permissible tilt range is detected during the unlocked state in order to prevent an irregular dispensing process, as taught by 5MED [0010], thereby actuating the locking mechanism in a locked position.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrico et al. (US 20120080448 A1) and Burns et al. (US 5284133 A) as applied to claim 1 above, and further in view of Carter et al. (US 20100084433 A1).
Regarding claim 9, modified Carrico teaches the assistance device according to claim 1, but is silent as to wherein the assistance device comprises at least one indentation configured to prevent the moving part of the dispensing device from returning to the rest position after a displacement along a predetermined stroke of the moving part of the dispensing device, the predetermined stroke being shorter than a total stroke corresponding to the stroke leading to the activation position of the dispensing device.
However, Carter teaches a discharge device (title) wherein an assistance device (locking ring 452; figure 11a-12b) comprises at least one indentation ([0120-0121] locking steps 461; figure11a-12b) configured to prevent the moving part of the dispensing device (operating member 488; figure 11a-11c) from returning to the rest position after a displacement along a predetermined stroke of the moving part of the dispensing device ([0120] If the operating member 488 is pressed downwards from a non-locked starting position according to FIG. 11a in the direction of arrow 1a, said operation results first in a turning of the locking ring 452 in a manner as described in the above embodiments, and simultaneously a medium discharge is started. As soon as the cams 494 of the operating member 488 reach the vicinity of the locking steps 461, they are deflected radially inwards by the chamfers 461a and go back to a non-deflected condition after overriding the locking steps 461 in the vicinity of the locking edges 461b. After reaching said condition, a return of the operating member 488 to the previously occupied starting position is inhibited for the time being, as the cams 94 can not be lead across the return steps 461 in the return stroke direction 1b, as shown in FIG. 11b), the predetermined stroke being shorter than a total stroke corresponding to the stroke leading to the activation position of the dispensing device (see [0120-0121] and figure 11a-11c).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assistance device of Carrico to implement at least one indentation in the form of locking steps configured to prevent the moving part of the dispensing device from returning to the rest position after a displacement along a predetermined stroke shorter than a total stroke of the moving part of the dispensing device, in order to prevent a user from misusing the device by executing repeated partial stroke movements, as taught by Carter [0121].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schuler et al. (US 20020000225 A1) teaches a locking mechanism activated by nitinol.
Wermeling et al. (US 20030163099 A1) teaches actuation via a nitinol wire or other shape memory alloy wire.
Haruta et al. (US 20210393897 A1) teaches a medicine dispensing device with a fixing means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785