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 statements (IDSs) submitted on 06/15/23, 07/07/23, 04/01/24, 07/03/24, 07/10/25, 10/06/25, and 01/02/26 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 06/29/23 has been entered. Claims 1-17 are cancelled. Claims 18-37 are newly presented.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “2” has been used to designate both a transfer member, a moveable member, a drive member, and a rotating collar (see [0126]).
reference character “4” has been used to designate both a housing element and a drive spring holder (see [0126]).
reference character “5” has been used to designate both a release element, a protection member, and a needle shroud (see [0129]).
reference character “51” has been used to designate both a stop feature, a displaceable element, and a resilient arm (see [0190]).
reference character “210” has been used to designate both a displaceable axial-lock element, a resilient arm, and a resilient clip (see [0225]).
Reference character “110a” has been used to designate both a radially displaceable cap-lock element and a resilient arm (see [0213])
Reference character “52” has been used to designate both a cap-lock element, a recess, and a cut-out (see [0213])
Applicant is encouraged to check the specification and drawings for other double designations.
Applicant can use different numerals to designate the different structural elements to overcome this drawing objection. Alternatively, if the numerals are referring to the same structure (for example, if the transfer member is the moveable member, the drive member, and the rotating collar), Applicant could amend the specification to use consistent language for the structure throughout the disclosure (for example, call all recitations of structure 2 the “transfer member” and remove all mentioning of “moveable member”, “drive member”, and “rotating collar”). Or the claims could subsequently be amended to reflect the same structural element (for example, transfer member in the claims could become the rotating collar and then all recitations of numeral 2 in the specification should be associated with the structure of “rotating collar”).
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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the a third locking feature as in at least claim 24 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Although a third locking feature is generally described in [0060-0062] & [0065-0067], a third locking feature does not appear to be depicted in any of the drawings. [0060-0062] seem to suggest that the third locking feature is a protrusion and/or a recess but, again, neither of these examples seem to be depicted in the drawings. Fig. 34 to 38 and [0188-0208] generally describe a third locking “mechanism”, but these portions of the description seem to only reference a protrusion/recess as in the releasable first locking mechanism comprising the resilient arm 51 and corresponding recess. Thus, it is unclear if this section of the description regarding the third locking “mechanism” is the same as the third locking “feature” claimed in claim 24. Therefore, the third locking feature appears not to be shown.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The transfer member moving proximally to release the first locking mechanism as in claim 34 is not described (See 112b rejection of claim 34 below).
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 18 line 6: “an energy member configured to provide energy”. Therefore, claim 18 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “an energy member” is considered a generic placeholder for “means” because “an energy member” has no specific structural meaning
Prong 2: functional language—configured to provide energy
Prong 3: not modified by other structural language in the claims—no structure is recited for how the energy member functions in order to achieve provide energy to induce a torque on the transfer member. Only the desired outcome of “provide energy” is recited.
According to Applicant’s disclosure under 112(f), the “energy member configured to provide energy” is interpreted as a spring or equivalent (see [0126] and [0128]). All depending claims are subsequently interpreted under 112(f) for this structure unless otherwise specified below.
Claim 18 lines 11-12: “a releasable first locking mechanism prevents a rotational movement of the transfer mechanism”. Therefore, claim 18 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a releasable first locking mechanism” is considered a generic placeholder for “means” because “a releasable first locking mechanism” has no specific structural meaning
Prong 2: functional language—prevents a rotational movement
Prong 3: not modified by other structural language in the claims—no structure is recited for how the releasable first locking mechanism functions in order to achieve preventing a rotational movement. Only the desired outcome of prevents a rotational movement is recited.
According to Applicant’s disclosure under 112(f), the releasable first locking mechanism preventing a rotational movement of the transfer member is interpreted as a resilient arm in a recess or equivalent (see [0174-0177]: a resilient arm 41 in a recess 410). All depending claims are subsequently interpreted under 112(f) for this structure unless otherwise specified below.
Claim 18 line 15: “an axial-lock interface which prevents an axial movement of the transfer member”. Therefore, claim 18 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “an axial-lock interface” is considered a generic placeholder for “means” because “an axial-lock interface” has no specific structural meaning
Prong 2: functional language—prevents an axial movement
Prong 3: not modified by other structural language in the claims—no structure is recited for how the axial-lock interface functions in order to achieve prevention of an axial movement of the transfer member. Only the desired outcome of preventing an axial movement of the transfer member is recited.
According to Applicant’s disclosure under 112(f), the axial-lock interface which prevents an axial movement is interpreted as a resilient arm in a recess or equivalent (see [0225]: resilient arm 210 in recess 44). All depending claims are subsequently interpreted under 112(f) for this structure unless otherwise specified below.
Claim 21 line 4: “a rotation-lock interface which prevents a rotation of the transfer member”. Therefore, claim 21 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a rotation-lock interface” is considered a generic placeholder for “means” because “a rotation-lock interface” has no specific structural meaning
Prong 2: functional language—prevents a rotation
Prong 3: not modified by other structural language in the claims—no structure is recited for how the rotation-lock interface functions in order to achieve prevention of a rotation of the transfer member. Only the desired outcome of preventing a rotation is recited.
According to Applicant’s disclosure under 112(f), the rotation-lock interface which prevents a rotation of the transfer member is interpreted as a resilient arm in a recess or equivalent (see [0174-0177]: a resilient arm 41 in a recess 410). All depending claims are subsequently interpreted under 112(f) for this structure unless otherwise specified below.
Claim 30 line 6: “the first cap-lock element engages with the second cap-lock element”. Therefore, claim 30 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a first cap-lock element” is considered a generic placeholder for “means” because “a first cap-lock element” has no specific structural meaning
Prong 2: functional language—engages with
Prong 3: not modified by other structural language in the claims—no structure is recited for how the first cap-lock element functions in order to achieve the engagement with the second cap-lock member. Only the desired outcome of “engages” with is recited.
According to Applicant’s disclosure under 112(f), the first cap-lock element that engages with the second cap-lock element is interpreted as a resilient arm or equivalent (see FIG.42 and [0213]: cap-lock element 110a is a resilient arm). All depending claims are subsequently interpreted under 112(f) for this structure unless otherwise specified below.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
Claim 23 because further structure for the first locking mechanism is recited such as a protrusion and a recess
Claim 37 because further structure for the axial-lock interface is recited such as a resilient arm or clip
Claims 31-32 because further structure for the first cap-lock element is recited such as a displaceable cap-lock element being displaceable in a radial direction
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 21 and 34 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.
Regarding claim 21, in view of Applicant’s specification, it is unclear to the examiner how the transfer member is held in the first position via a “rotation-lock interface”. In claim 18, a releasable first locking mechanism is recited that “prevents a rotational movement of the transfer member” and the transfer member is coupled to the displaceable element held in the first position “via an axial-lock interface”. According to Applicant disclosure for these structures, the releasable first locking mechanism involves the structure of a resilient arm and recess (see [0174-0177]). The axial-lock interface involves a separate resilient arm and recess (see [0225]). In Applicant disclosure, the rotation-lock interface seems to also only rely upon the first resilient arm and recess structure (see [0174-0177]). Therefore, it is unclear to the examiner if the rotation-lock interface of claim 21 is the same structure as the first locking mechanism or if the rotation-lock interface is supposed to be a separate structure.
In view of the description of Applicant disclosure in [0174-0177] and for purposes of examination, the examiner will interpret the releasable first locking mechanism to be the structures of the resilient arm and recess. Meanwhile, the rotation-lock interface will be interpreted as the engagement of the arm in the recess such as an engaged position of the releasable first locking mechanism.
Regarding claim 34, in view of Applicant’s specification, it is unclear to the examiner how the transfer member moves proximally to “release” the first locking mechanism. According to Applicant disclosure (See [0184], [0206], and [0254]), the release member 5 moves proximally to cause the transfer member to rotate (see specifically [0254]), which is the movement that “releases” the first locking mechanism. Therefore, for purposes of examination and to align with the structures as disclosed by Applicant, the examiner interprets claim 34 to read “and a movement of the [[transfer]] release member in the proximal direction releases the releasable first locking mechanism”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-20, 22, 25-26, 29, 33-35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roberts et al. (U.S. PGPUB No. 2013/0204196), hereinafter Roberts.
Regarding claim 18, Roberts discloses a drug delivery device comprising:
a housing element (1.2, see [0043] and ‘Modified FIG. 4’ below);
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a release member (1.1) arranged axially movable (see [0080-0083]) with respect to the housing element (1.2);
a plunger rod (2.5) arranged axially movable (see [0083] and position of rod 2.5 from FIG. 3 to FIG. 10) with respect to the housing element (1.2);
a transfer member (1.4) arranged rotatably (see [0046] & [0057]: rotating collar 1.4) with respect to the housing element (1.2);
an energy member (1.6) configured to provide energy to induce a torque onto the transfer member (1.4, see [0061] and [0087]: spring energy results in rotation of collar and therefore spring is “configured to provide energy to induce a torque”); and
a displaceable element (arms 1.4.1 of collar 1.4, see FIG. 5B and [0071]: 1.4.1 connected to collar that allows for resilient inward deflection. Thus, 1.4.1. reasonably a resilient arm as interpreted under 112f above.) being displaceable between a first position and a second position (see [0074-0078]: different positions of the displaceable element 1.4.1. first position PS, see [0075]: 1.4 retained in start position PS at proximal end of inclined section 1.2.2.1 and second position PPE, see [0092]),
wherein the transfer member (1.4) and the plunger rod (2.5) are operatively coupled such that a rotation of the transfer member (1.4) is converted into an axial movement of the plunger rod (2.5, see [0083]: 2.5 only able to deliver medicine after collar 1.4 rotates as in [0084-0089]),
wherein the drug delivery device has a first state in which (i) a releasable first locking mechanism (arms 1.4.1 in recesses of guide track 1.2.2 as seen in FIG. 6. Specifically see [0075]: 1.4 retained in start position PS at proximal end of inclined section 1.2.2.1) prevents a rotational movement (see [0075]: 1.4 retained in position and thus rotation is prevented) of the transfer member (1.4) by the energy member (1.6) (ii) the release member (1.1) is in an initial position (II, see FIG. 3 and [0056]) and arranged to hold (see [0061]: spring between 1.1 and 1.4. Thus, 1.1 “arranged to hold” displaceable element in position by way of spring because spring 1.6 not activated until needle shield 1.1 moves as in [0083]) the displaceable element (1.4.1) in the first position (PS) and (iii) the transfer member (1.4) is coupled to (see FIG. 5B) the displaceable element (1.4.1) held in the first position (PS) via an axial-lock interface (1.5.2 in recess of the incline 1.2.3, see ‘Modified FIG. 4i’ below and [0065])
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which prevents an axial movement of the transfer member (1.4) at least in an axial direction (see [0057]: 1.4 retained in position/ prevented from moving by collar 1.5 having the axial-lock interface as described in [0065] & [0093]).
Regarding claim 19, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses wherein the drug delivery device is configured to be (configured to is functional language. Therefore the device need only be capable of performing the following limitations) switchable from the first state into a released state (after needle shield 1.1. initially moved out of position II as beginning in [0083]) by moving the release member (1.1) from the initial position (II, see FIG. 4 and [0056]) axially into a release position (I, see [0083]. Position I only shown in FIG.9 which is a view of the device after a complete injection stroke but can be viewed to see position I of needle shield),
wherein, in the released state, (i) the release member (1.1) is in the release position (I) and no longer holds (see [0087] & [0091]: spring force 16 released) the displaceable element (1.4.1) in the first position (PS), which allows a movement of the displaceable element (1.4.1) from the first position (PS) into the second position (toward PPE, see [0092]) to resolve the axial-lock interface (1.5.2 in recess of incline 1.2.3, see [0093]: 1.4 moves proximally resolving axial lock interface by deflecting arms 1.5.2 inwardly) and to enable a movement of the transfer member (1.4) in the axial direction (see [0093]: proximally), (ii) the energy member (1.6) provides a torque onto (see at least [0083-0087]) the transfer member (1.4), and (iii) the releasable first locking mechanism (1.4 at proximal end of 1.2.2.1 in PS as in [0075]) is released (see [0085]: 1.4.1 moves out of proximal end of 1.2.2.1) so that the transfer member (1.4) rotates in a first rotational direction (see [0085]: 1.4 rotates) due to the provided torque (see [0083-0085]) and forces the plunger rod (2.5) to move axially in a distal direction (see [0105]).
Regarding claim 20, Roberts discloses the drug delivery device according to claim 19, and Roberts further discloses wherein in the released state (see [0083]), the transfer member (1.4) is configured to move in the axial direction (see [0084]: distally and [0093]: then proximally).
Regarding claim 22, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses comprising:
a first lock element (1.2.2.1 of guide track 1.2.2, see FIG. 6) rotationally and axially fixed with respect to (see [0046]: 1.2.2 in support body 1.2 and thus axially and rotational fixed “with respect to” 1.4) the transfer member (1.4),
wherein in the first state, (i) the first lock element (1.2.2.1) and the displaceable element (1.4.1) held in the first position are engaged with each other (first position in [0075]: 1.4 retained in start position PS at proximal end of inclined section 1.2.2.1 by 1.4.1), and (ii) the engagement of the first lock element (1.2.2.1) and the displaceable element (1.4.1) prevents an axial movement of the transfer member (1.4) at least in the axial direction (see [0075]: position retained and all movement prevented).
Regarding claim 25, Roberts discloses the drug delivery device according to claim 22, and Roberts further discloses wherein:
one of the first lock element (1.2.2.1, see FIG. 6) or the displaceable element comprise a slide feature (see [0074]: 1.2.2.1 comprises inclined surface) against which the other of the first lock element or the displacement element (1.4.1) is configured to abut (see [0085]: 1.4.1 abuts surface of 1.2.2.1) and along which the other of the first lock element or the displacement element (1.4.1) is configured to slide (see [0085]: 1.4.1 slides along surface of 1.2.2.1) for allowing a disengagement of (see [0085-0087]: sliding along surface of 1.2.2.1 allows 1.4.1 to be moved out of proximal end of 1.2.2.1, which “allows” disengagement of 1.4.1 and proximal end of 1.2.2.1) the first lock element (1.2.2.1) and the displaceable element (1.4.1), and
the slide feature (see [0074]: 1.2.2.1 comprises inclined surface) comprises a beveled surface that is tilted with respect to a rotational direction and/or radial direction (see ‘Modified FIG. 6’ below: beveled surface of 1.2.2.1 is sloped/tilted relative to the rotational direction and see [0074-0075]).
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Regarding claim 26, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses wherein:
the drug delivery device is configured such that, in a released state, the energy member (1.6, see FIG. 4) provides a force (see [0061]: spring initially forcing collar and displaceable element toward first position and [0087]: after release, spring 1.6 gives force in distal/ opposite direction of the first position) onto the displaceable element (1.4.1) acting in a direction to move the displaceable element (1.4.1) away from the first position (1.4.1 retained in proximal end of 1.2.2.1 as in [0075]), and/or (AND. The device discloses the positively recited limitation and thus also discloses the functionally recited limitation)
the energy member is configured to provide a force onto the displaceable element in the first state, the force being directed to move the displaceable element away from the first position.
Regarding claim 29, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses comprising:
a housing (1.3, see FIG. 4) with the housing element (1.2) fixed to or integrated in (see [0043]: proximal end of 1.2 fixed in housing 1.3) the housing (1.3); and
a medicament container (2, see [0058]: syringe 2 with medicament in cavity) with a needle (2.1, see [0048]),
wherein the release member (1.1) is telescopically coupled to (see [0043]) the housing (1.3) and, in the first state, is axially movable in a proximal direction (see [0083]) with respect to the housing (1.3) from the initial position (II, see FIG.4) in which the needle (2.1) is covered by (as seen in FIG. 4) the release member (1.1) to a release position (I, position I seen in FIG. 9 and see [0083]: needle penetrates skin at position I and therefore cannot be covered by the release member) in which the needle (2.1) is not covered by (as shown in FIG. 9) the release member (1.1).
Regarding claim 33, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses wherein the drug delivery device is a single use device (see [0013]: device prevented from being re-used) and/or is a disposable device.
Regarding claim 34, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses wherein the axial direction is a proximal direction (see [0075]: all movement of the transfer member, including in a proximal direction, is initially prevented by position retained at PS), and a movement of the [[transfer]] release member (1.1) in the proximal direction (see [0083]) releases the releasable first locking mechanism (see [0083-0086]: proximal movement of 1.1 allows transfer member 1.4 to rotate which releases the locking mechanism of 1.4.1. disposed in 1.2.2.1).
Regarding claim 35, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses comprising a medicament container (2, see FIG. 4) comprising a medicament or a drug (see [0058]: pre filled syringe has cavity 2.3.1 with medication).
Regarding claim 37, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses wherein the axial-lock interface (1.5.2 in recess of the incline 1.2.3, see ‘Modified FIG. 4i’ above and [0065]) is a resilient arm or a clip (see [0064-0065]: 1.5.2 described as arm that is deflectable and therefore is a resilient arm).
Claims 18, 21-24, and 27-28 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Bendek et al. (U.S. PGPUB No. 2016/0361503), hereinafter Bendek.
Regarding claim 18, Bendek discloses a drug delivery device comprising:
a housing element (4, see Fig.3 and [0039]: housing 4 formed of two halves, 4a/4b);
a release member (13) arranged axially movable with respect to (see [0045]: 13 slides relative to housing) the housing element (4);
a plunger rod (9) arranged axially movable with respect to (see [0040]: plunger 9 moves distally to dispense medicament) the housing element (4);
a transfer member (14, see numeral 14 in FIG. 6 and see ‘Modified FIG. 3’ below)
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arranged rotatably with respect to (see FIG. 7 and [0046]: 14 rotates counterclockwise) the housing element (4);
an energy member (8) configured to provide energy to induce a torque onto the transfer member (see [0041-0044], specifically [0044]: constant force profile/ torsion springs, aligning with Applicant disclosure in [0126] for inducing torque); and
a displaceable element (resilient arm formed of 26&27, see FIG. 7 and [0046]: spring arms 26) being displaceable between (displacement occurs during rotation as described in [0046-0047]) a first position (at the moment where displaceable element extends radially outward by a ‘gap’ and engages 28 with 27, see ‘Modified FIG. 6 & 7’ below) and a second position (during rotation with displaceable element compressed radially inward by 28, see ‘Modified FIG. 6 & 7’ below and [0046]: engagement of 27/28 moves arms 26 to provide a counter biasing force to counter-rotate transfer member 14),
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wherein the transfer member (14) and the plunger rod (9) are operatively coupled (see [0046]: plunger and transfer member 14 coupled at through hole 14a) such that a rotation of the transfer member (14) is converted into an axial movement of the plunger rod (9, see [0047] plunger cannot move distally until rotation moves protrusions 24 of transfer member into grooves 22 of plunger),
wherein the drug delivery device has a first state (before complete rotation, when beams 29 first come through to contact the latch and engage 27&28) in which (i) a releasable first locking mechanism (27 & 28, see FIG. 6) prevents a rotational movement of the transfer member (14, see [0046]: at the point in time when 27&28 first contact/ become engaged but the arms 26 have not radially compressed inward, there is no rotational movement allowed) by the energy member (8) (ii) the release member (13) is in an initial position and arranged to hold (see [0045-0046]: beams 29 of release member 13, see FIG. 4, before the user pushes toward injection site to retract 13, no rotation of 14 is possible. Thus, before rotation/ before retraction of the release member 13, 13 is in an “initial position” that is “arranged” to hold the displacement element in the first position) the displaceable element (resilient arm formed of 26&27) in the first position (before rotation) and (iii) the transfer member (14) is coupled to the displaceable element (resilient arm formed of 26&27) held in the first position (at the moment where displaceable element extends radially outward by a ‘gap’ and engages 28 with 27) via an axial-lock interface (23&24, see [0047]: engagement between protrusion 24 and recess 23 prevent axial movement until rotation occurs) which prevents an axial movement of the transfer member (14) at least in an axial direction (see [0047]).
Regarding claim 21, Bendek discloses the drug delivery device according to claim 18, and Bendek further discloses wherein:
the displaceable element (resilient arm formed of 26&27, see FIG. 6) is part of the releasable first locking mechanism (27&28), and
in the first state, the transfer member (14) is coupled to the displaceable element (resilient arm formed of 26&27) held in the first position (when 27 first contacts 28) via a rotation-lock interface (engagement of 27&28) which prevents a rotation (see [0046]: at the point in time when 27&28 first contact/ become engaged but the arms 26 have not radially compressed inward, there is no rotational movement allowed) of the transfer member (14) by the energy member (8).
Regarding claim 22, Bendek discloses the drug delivery device according to claim 18, and Bendek further discloses comprising:
a first lock element (28, see FIG. 6 and [0046]: proximal inside surface of 15 eventually form catches 28) rotationally and axially fixed with respect to (28 on structure 15 which, see [0046]: is axially and rotationally fixed relative to housing and subsequently the transfer member) the transfer member (14),
wherein in the first state, (i) the first lock element (28) and the displaceable element (resilient arm formed of 26&27) held in the first position (see [0046]: at the point in time when 27&28 first contact/ become engaged but the arms 26 have not radially compressed inward) are engaged with each other (when 27 and 28 first contact but 26 is not compressed, 27&28 are still engaged), and (ii) the engagement of the first lock element (28) and the displaceable element (resilient arm formed of 26&27) prevents an axial movement of the transfer member (14) at least in the axial direction (see [0046-0047]: at the point in time when 27&28 first contact/ become engaged but the arms 26 have not radially compressed inward, there is no rotational movement allowed which subsequently prevents axial movement of the structural elements).
Regarding claim 23, Bendek discloses the drug delivery device according to claim 22, and Bendek further discloses wherein:
the first lock element (28, see FIG. 6) comprises a first locking feature (recess formed in 28) and the displaceable element (resilient arm formed of 26&27) comprises a second locking feature (27),
one of the first or second locking feature (27) is a protrusion (see spring stop form 27 that protrudes relative to the rectangular cross-section of the arm 26, see FIG. 7), and the other of the first (28) or second locking feature is a recess (see recess formed in inside surface by 28 in FIG. 6),
when the first lock element (28) and the displaceable element (resilient arm formed of 26&27) are engaged (when 27 and 28 first contact but 26 is not compressed, 27&28 are still engaged), the protrusion (“spring stops” 27) projects into the recess (recess formed by 28 as described in [0046]),
the protrusion (spring stops 27) and the recess (recess formed by surface 28) each have a surface extending obliquely (stops 27 and recess of 28 both have circular cross-sections and thus must have at least “a” surface that extends obliquely/ non-parallel & non-perpendicular to the longitudinal axis) with respect to the axial direction (along a longitudinal axis of the device), and
when the first lock element (28) and the displaceable element (resilient arm formed of 26&27) are engaged (when 27 first contacts 28 but 26 is not yet compressed), the respective surfaces of the protrusion (stops 27) and the recess (recess formed by catch 28) are arranged to abut against each other to prevent a movement of the transfer member in the axial direction (see [0046-0047]: at the point in time when 27&28 first contact/ abut but the arms 26 have not radially compressed inward, there is no rotational movement allowed which subsequently prevents axial movement of the structural elements).
Regarding claim 24, Bendek discloses the drug delivery device according to claim 23, and Bendek further discloses comprising a third locking feature (15, see FIG. 3) axially, rotationally, and radially fixed with respect to (see [0040]: radially fixed and [0046]: rotationally/axially fixed) the housing element (4), wherein:
the third locking feature (15) is arranged axially offset (proximal surface of 15 located proximally/ axially offset of 27, see FIG. 6) with respect to the second locking feature (27) of the displaceable element (resilient arm formed of 26&27) and aligned in a rotational direction (walls of 15 “aligned” in the rotational direction of 14 as shown in FIG. 6) with the second locking feature (27) of the displaceable element (resilient arm formed of 26&27),
the third locking feature (15) is configured to engage with (see [0046]: 28 formed of an “inside surface” of 15. Therefore 15 engages 28 by way of the proximal inside surface) the first locking feature (recess formed of 28) of the first lock element (28),
the second locking feature (protruding stops 27) of the displaceable element (resilient arm formed of 26&27) comprises two sections (each radial arm is one section. Therefore, the two radial arms 26 form two “sections”) between which a surface running obliquely to the axial direction (slanted relative the longitudinal axis) is formed (see ‘Modified FIG. 6i’ below),
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and
the third locking feature (15) and a first section (outside edge of 27, see ‘Modified FIG. 6i’ above) of the second locking feature (protruding stops 27) of the displaceable element (resilient arm formed of 26&27) are radially aligned (see ‘Modified FIG. 6i’ above).
Regarding claim 27, Bendek discloses the drug delivery device according to claim 18, and further discloses wherein the displaceable element (resilient arm formed of 26&27, see FIG. 6) is orientated circumferentially (see FIG. 6 with 26/27 extending circumferentially around inner ring of 14), is a resilient arm (see [0046]: structure 26 described as “spring” arm), is displaceable in a radial direction (as seen in FIG. 7 compared to radial placement of FIG. 6 and described in [0046-0047]), and in the first state (before complete rotation, when beams 29 first come through to contact the latch and engage 27&28), the displaceable element (resilient arm formed of 26&27) abuts against the release member (13) in the radial direction (see [0045-0046]: arms 29 of 13 come through the holes 30 of member 15 and abut member surfaces 31a to cause inward deflection and rotation of arms 26. Thus, 29a also abutting 26 at least by way of 31 as shown in ‘Modified Figs. 5 &7’ below).
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Regarding claim 28, Bendek discloses the drug delivery device according to claim 18, and Bendek further discloses wherein:
the release member (13) comprises a first section and a second section (see first and second sections in ‘Modified FIG. 4’ below),
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in the initial position (when 29 engages 14 to initiate first touching of 27&28) of the release member (13), the first section (51) overlaps with the displaceable element (resilient arm of 26/27) along the axial direction (all components aligned within housing along an axial direction, such as the axial direction axis shown in ‘Modified FIG. 2’ below)
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and holds the displaceable element (resilient arm of 26/27) in the first position (see [0045-0047]: before inward deflection of arms, no rotation occurs. Rhus the displaceable element is “held” in position by positioning of release member),
in the release position of the release member (see [0046-0047] when 26/27 rotate), the second section (see ‘Modified FIG. 4’ above) overlaps with the displaceable element along the axial direction (29 is engaging the cam 31 and therefore overlaps in an axial direction) and allows the displaceable element (resilient arm of 26/27) to move out of the first position (see [0047]), and
the second section (see ‘Modified FIG. 4’ above) comprises or is a recess (see ‘Modified FIG. 4’ above) in the release member (13).
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.
Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts as applied to claim 29 above, and further in view of Mosebach et al. (U.S. PGPUB No. 2018/0169349), hereinafter Mosebach.
Regarding claim 30, Roberts discloses the drug delivery device according to claim 29, and Roberts further discloses comprising a cap (2.2, see FIG. 1) removably couplable (see [0048] and [0053]) to a distal end (1.2 forms distal end of housing 1.3 due to telescopic arrangement, see [0043]) of the housing (1.3), wherein when the cap (2.2) is coupled to the housing (seeFIG.1), the cap (2.2) is in a proximal-most position with respect to the housing (1.3) and is not movable further in proximal direction (see [0048]), and the cap (2.2) comprises a feature for frictionally engaging the release member (1.1) such that a movement of the release member (1.1) is prevented (see [0052]: cap 2.2 frictionally engaged release member 1.1 to retain position).
Roberts is silent to “the cap comprising a first cap-lock element, and wherein when the cap is coupled to the housing and the release member is in the initial position, the first cap-lock element engages with a second cap-lock element of the release member such that a movement of the release member from the initial position into the release position is prevented.”
However, Mosebach teaches a drug delivery device (see FIG. 1) with a cap (11) removably coupleable (see [0070] cap removeable) to a distal end of a housing (2, see [0054]: cap 11 abuts radial stop 2.15 of housing 2), the housing comprising a release member (7), and the cap (11) comprising a first cap-lock element (11.3), wherein when the cap (11) is coupled to the housing (as in FIG. 1), and wherein when the cap (11) is coupled to the housing (as in FIG.1) and the release member is in an initial position (see [0070-0071]: release member 7 cannot move until cap is removed), the first cap-lock element (11.3) engages with a second cap-lock element (7.6, see FIG. 2 and [0054]) of the release member (7) such that a movement of the release member (7) from the initial position into the release position is prevented (see [0070-0071]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the frictional engagement between the cap and release member disclosed in Roberts to specifically be an engagement of a first cap-lock element and a second cap-lock element as taught by Mosebach for the purpose of reducing the force necessary for removal of the cap (see [0054]), thus achieving “the cap comprising a first cap-lock element, wherein when the cap is coupled to the housing, the cap is in a proximal-most position with respect to the housing and is not movable further in proximal direction, and wherein when the cap is coupled to the housing and the release member is in the initial position, the first cap-lock element engages with a second cap-lock element of the release member such that a movement of the release member from the initial position into the release position is prevented.”
Regarding claim 31, Roberts discloses the drug delivery device according to claim 30, but Roberts is silent to “wherein:one of the first cap-lock element or the second cap-lock element is a displaceable cap- lock element being displaceable in a radial direction, and when the cap is coupled to the housing, the first and second cap-lock elements are engaged and a radial movement of the displaceable cap-lock element out of the engagement is prevented by the housing abutting against the displaceable cap-lock element in the radial direction.”
However, Mosebach teaches a drug delivery device (see FIG. 1) with a cap (11) removably coupleable (see [0070]: cap removeable) to a housing (2), the cap (11) having a first cap-lock element (11.3) and a second cap-lock element (7.6), wherein:
one of the first cap-lock element (11.3) or the second cap-lock element is a displaceable cap- lock element being displaceable in a radial direction (see [0054]: 11.3 deflect to disengage apertures 7.6), and
when the cap (11) is coupled to the housing (2, as in FIG.1), the first (11.3) and second (7.6) cap-lock elements are engaged and a radial movement of the displaceable cap-lock element (see [0054]) out of the engagement is prevented by the housing (see [0054]: radial stop 2.15 of housing abuts 11.3 and prevents disengagement) abutting against the displaceable cap-lock element (see [0054]: 11.3 deflectable and thus is the displaceable cap-lock element) in the radial direction (see ‘Modified FIG. 2’ below).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the frictional engagement between the cap and release member disclosed in Roberts to specifically be an engagement of a first cap-lock element and a second cap-lock element with the first cap-lock element being prevented by the housing from moving radially as taught by Mosebach for the purpose of reducing the force necessary for removal of the cap (see [0054]) and to ensure that the cap is not unintentionally removed from the housing (see [0054]), thus achieving “wherein:one of the first cap-lock element or the second cap-lock element is a displaceable cap- lock element being displaceable in a radial direction, and when the cap is coupled to the housing, the first and second cap-lock elements are engaged and a radial movement of the displaceable cap-lock element out of the engagement is prevented by the housing abutting against the displaceable cap-lock element in the radial direction.”
Regarding claim 32, Roberts discloses the drug delivery device according to claim 31, but Roberts is silent to “wherein:the first and second cap-lock elements are configured such that, when the first and second cap-lock elements are engaged, a distal movement of the cap from the proximal-most position of the cap is allowed, the movement of the cap in the distal direction allows a disengagement of the first and second cap-lock elements with respect to each other, and one of the first or second cap-lock elements comprise a slide feature along which the other of the first or second cap-lock element is configured to slide when removing the cap from the housing in the distal direction.”
However, Mosebach teaches a drug delivery device (see FIG. 1) with a cap (11), the cap (11) having a first cap-lock element (11.3) and a second cap-lock element (7.6), wherein:
the first (11.3) and second (7.6) cap-lock elements are configured such that, when the first (11.3) and second (7.6) cap-lock elements are engaged (see FIG. 2), a distal movement of the cap (11) from a proximal-most position of the cap is allowed (see [0054] and [0070]),
the movement of the cap in the distal direction allows a disengagement of the first (11.3) and second (7.6) cap-lock elements with respect to each other (see [0070]), and
one of the first (11.3) or second (7.6) cap-lock elements comprise a slide feature (see [0054]: 11.3/ 7.6 or both can have ramped surfaces) along which the other of the first or second cap-lock element is configured to slide when removing the cap from the housing in the distal direction (see [0054]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the frictional engagement between the cap and release member disclosed in Roberts to specifically be an engagement of a first cap-lock element and a second cap-lock element that comprise slide features that allow distal movement of the cap as taught by Mosebach for the purpose of reducing the force necessary for removal of the cap (see [0054]), thus achieving “wherein:the first and second cap-lock elements are configured such that, when the first and second cap-lock elements are engaged, a distal movement of the cap from the proximal-most position of the cap is allowed, the movement of the cap in the distal direction allows a disengagement of the first and second cap-lock elements with respect to each other, and one of the first or second cap-lock elements comprise a slide feature along which the other of the first or second cap-lock element is configured to slide when removing the cap from the housing in the distal direction.”
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts as applied to claim 18 above, and further in view of Stefansen et al. (U.S. PGPUB No. 2017/0136192), hereinafter Stefansen.
Regarding claim 36, Roberts discloses the drug delivery device according to claim 18, and Roberts further discloses comprising a medicament container (2, see FIG. 4 and [0058]: syringe 2 having cavity 2.3.1 with medication) comprising a stopper (2.4).
Roberts is silent to “wherein in the first state, the plunger rod is axially spaced from the stopper.”
However, Stefansen teaches a drug delivery device (see Fig.1a) comprising a plunger rod (310) and a medicament container (600, see [0100]: medication filled cartridge 600) comprising a stopper (630), wherein in a first state (as in FIG. 1a), the plunger rod (310) is axially spaced from the stopper (630, See ‘Modified FIG. 1a’ below and [0138]: axial space is resolved in FIG.2a)
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger rod and stopper disclosed in Roberts to include an axial space between in the first state as taught by Stefansen for the purpose of more accurately defining a stroke distance (see [0113]) and/or ensuring that the plunger does not deliver medication too early (see [0137-0138]), such as before the cap is removed and the needle is penetrating the skin, thus achieving “wherein in the first state, the plunger rod is axially spaced from the stopper.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783