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, and 10/06/25 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 to the specification filed 06/29/23 has been entered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “4” has been used to designate both the housing element and the drive spring holder (see [0111]).
reference character “5” has been used to designate both the release element, protection member, and the needle shroud (see [0114]).
reference character “51” has been used to designate both the stop feature, the displaceable element, and the resilient arm (see [0175]).
Reference character “2” has been used to designate both a transfer member, a moveable member, a drive member, and a rotating collar (see [0111]).
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 drive spring holder is the housing element), Applicant could amend the specification to use consistent language for the structure throughout the disclosure (for example, call all recitations of structure 4 the “drive spring holder” and remove all mentioning of “housing element”). The claims could subsequently be amended to reflect the same structural element (for example, housing element in the claims would become the drive spring holder).
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.
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 17 lines 5-6: “an energy member configured to provide energy to induce an axial movement of the plunger rod in a distal direction”. Therefore, claim 17 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 provides energy to induce axial movement of the plunger rod. Only the desired outcome of “induce axial movement” is recited.
According to Applicant’s disclosure under 112(f), the an energy member configured to provide energy to induce an axial movement of the plunger rod in a distal direction is interpreted as a spring or equivalent (see Fig. 3 and [0111]: energy member in the form of a drive spring). All subsequent recitations of “energy member” in the depending claims is also interpreted as a spring or equivalent under 112(f).
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 § 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 17-22 and 26-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hostettler et al. (U.S. PGPUB No. 2018/0169346), hereinafter Hostettler.
Regarding claim 17, Hostettler discloses a drug delivery device comprising:
a housing element (2, see FIG. 1);
a release member (8 & 15, see [0113]) arranged axially movable (see [0115]: sleeves 8&15 moving in proximal direction==axially movable) with respect to the housing element (2);
a plunger rod (11) arranged axially movable (see acceleration path “x” in Fig. 2a and described in at least [0107]) with respect to the housing element (2);
an energy member (9&10) configured to provide energy to induce an axial movement of the plunger rod (11) in a distal direction (see [0106] & [0111]: spring 9 drives rod 11); and
a displaceable element (6a) being displaceable in a radial direction (see [0117]: 6a disengaged from mating with structure 7. As described in [0113]: 6a engaged with recess 7a of 7. Therefore, 6a must be displaced radially to disengage from the recess 7a and structure 7.),
wherein the drug delivery device has a first state (see [0083]: delivery state as shown in FIG. 2A & 2B and see “Modified Figure” below for visual clarity)
PNG
media_image1.png
526
828
media_image1.png
Greyscale
in which (i) the release member (8 & 15) is movable in a proximal direction from a distal position into a proximal position (see [0117]: sleeve 8 driven proximally in direction of HB shown in FIG. 3a. Thus, prior to sleeve 8 being driven proximally as in [0117], the device is in the “first state”, which is shown in FIG. 2A &B) and (ii) the release member (8 & 15) is in the distal position and arranged to hold the displaceable element in a first radial position (see [0113]: 8 &15 maintain 6a in recess 7a/ a first radial position) to prevent a movement of the plunger rod (11) in the distal direction by the energy member (see [0111-0113], specifically [0112]: spring 9 kept in loaded state such that drive member 7 cannot move in distal direction. See [0111]: spring 9 actuated under drive member 7),
wherein the drug delivery device is configured to be switched from the first state (delivery state as in FIG. 2A &2B) into a released state (see [0084]: actuated state as in FIG. 3a & 3b) by moving the release member (8 & 15) from the distal position (as in FIG. 2A) into the proximal position (as in FIG. 3a, see [0117-0118]: sleeve 8 driven proximally in direction of HB shown in FIG. 3a), wherein in the released state (FIG. 3A/B) (i) the release member (8&15) is in the proximal position (position moved proximally by HB shown in FIG. 3a) and no longer holds the displaceable element (6a) in the first radial position (see [0113]: the radial position when 6a engages recess 7a) which allows a movement of the displaceable element from the first radial position (see [0113]: 6a engages 7a) into a second radial position (see [0117]: 6a disengaged from mating with structure 7. As described in [0113]: 6a engaged with recess 7a of 7. Therefore, 6a must be displaced radially==a second radial position to disengage from the recess 7a and structure 7.) to release the plunger rod (11, see [0117-0118]: 7 is released and will ultimately, see [0111]: release of member 7 drives plunger rod to expel medicament) and (ii) the plunger rod when released moves in the distal direction due to the energy provided by the energy member (9, see [0111] and [0117-0118]).
Regarding claim 18, Hostettler discloses the drug delivery device according to claim 17, and Hostettler further discloses wherein in the first state (see [0083]: delivery state as shown in FIG. 2A & 2B), the plunger rod (11) is coupled to the displaceable element (6a) via a lock interface (see [0111-0113]: plunger rod held in place by coupling between drive member 7 and displaceable element 6a. see also [0101-0103] & [0105-0106]: plunger rod 11 coupled to drive member 7. Therefore the plunger rod is coupled to the displaceable element by way of the drive member) to prevent the axial movement of the plunger rod (11) by the energy member (9 & 10).
Regarding claim 19, Hostettler discloses the drug delivery device according to claim 17, and Hostettler further discloses wherein in the first state (see [0083]: delivery state as shown in FIG. 2A & 2B), the displaceable element (6a) abuts against the release member (8 &15) in the radial direction (see [0113]: inner periphery of sleeve 8 contacts==abuts against the outer surface==in radial direction of displaceable element 6a).
Regarding claim 20, Hostettler discloses the drug delivery device according to claim 17, and Hostettler further discloses wherein the displaceable element (6a, see FIG. 1) is oriented circumferentially (see [0112]: 6a radially faces the longitudinal axis and this is “oriented” circumferentially/ along a radial edge) and is a resilient arm (see [0112]: 6a is a protrusion formed on arm 6c).
Regarding claim 21, Hostettler discloses the drug delivery device according to claim 17, and Hostettler further discloses comprising:
a transfer member (7, see FIG. 1) movably arranged (see [0112]) with respect to the housing element (2), the transfer member (7) and the plunger rod (11) being operatively coupled (see [0101-0103] & [0105-0106]: 7/11 coupled in helical arrangement) such that a movement of the transfer member (7) in a first direction (see [0106]: 7 moves in distal direction under force of spring 9) is converted into a movement of the plunger rod (11) in the distal direction (see [0100-0111]: 7 moves distally under force of spring 9 and plunger rod 11 is moved along acceleration path x, see fig. 3a, in distal direction),
wherein in the released state (see [0084]: actuated state as in FIG. 3a & 3b), the energy member (9) provides a force (see [0106]) onto the transfer member (7) in which the transfer member (7) moves in the first direction (see [0106]: 7 moves in distal direction under force of spring 9) and thereby forces the plunger rod (11) to move axially in the distal direction (see [0100-0111]: 7 moves distally under force of spring 9 and plunger rod 11 is moved along acceleration path x, see fig. 3a, in distal direction).
Regarding claim 22, Hostettler discloses the drug delivery device according to claim 21, and Hostettler further discloses wherein in the released state (see [0084]: actuated state as in FIG. 3a & 3b), the transfer member (7) is configured to move axially with respect to the housing element (2, see [0117]: 7 moves distally by the dispensing stroke Ha) until the transfer member (7) contacts an end-stop (see Fig. 5a and [0119-0120]: 7 driven by stroke HA and then stops moving distally after medicament is injected, as shown in FIG. 5a-7a. Therefore, 7 must contact an “end stop”/ physical barrier via abutment with piston 13 within cartridge).
Regarding claim 26, Hostettler discloses the drug delivery device according to claim 21, and Hostettler further discloses comprising:
a first lock element (7a, see FIG. 1) movably arranged with respect to (see at least [0117]: 7 moves distally by the dispensing stroke Ha and therefore 7a must also move distally because 7a formed on 7) the housing element (2) and operatively coupled to the plunger rod (11), the first lock element (7a) being part of (as seen in FIG. 1 and described in [0112]) the transfer member (7),
wherein in the first state (as in Fig. 2a/b), the first lock element (7a) and the displaceable element (6a) are engaged with each other to prevent an energy member (9) induced movement of the plunger rod (11) in the distal direction (see [0112]: 6a/7a engaged to prevent distal movement by keeping spring 9 in loaded state).
Regarding claim 27, Hostettler discloses the drug delivery device according to claim 26, and Hostettler further discloses wherein one of the displaceable element (6a) or the first lock element comprises a protrusion (see FIG. 1 showing protruding surface of 6a and see [0112]: radially inward facing surface of 6a) and the other one of the displaceable element or the first lock element (7a) comprises a recess (see [0112]: recess 7a), and when the displaceable element (6a) and the first lock element (7a) are engaged with each other, the protrusion (protrusion of surface 6a) projects into the recess (recess of 7a, see [0112-0113]: inner periphery of sleeve 8 keeps protrusion engaged with recess and therefore at least a portion of the protrusion projects into recess to ensure engagement of structures. See also. Fig. 2b showing 6a projecting into/through recess 7a).
Regarding claim 28, Hostettler discloses the drug delivery device according to claim 26, and Hostettler further discloses wherein:
one of the first lock element or the displaceable element (6a) comprises a slide feature (see ramping edge of 6a in ‘Modified FIG. 1’ below)
PNG
media_image2.png
248
482
media_image2.png
Greyscale
against which the other one of the displaceable element or the first lock element (7a) is configured to abut (as shown in at least FIG. 2b & 3a and described in [0112]: 6a engages 7a) and along which the other one of the displaceable element or the first lock element (7a) is configured to slide for allowing a disengagement (disengagement shown in FIG. 4a and described in [0117]: disengagement by movement along longitudinal axis and therefore the lock element 7a is “configured to” slide along the longitudinal axis against slide feature to allow disengagement) of the first lock element (7a) and the displaceable element (6a), and
the slide feature (see ‘Modified FIG. 1’ above) comprises a beveled surface (see sloping edge of slide feature in ‘Modified FIG. 1’ above) that is tilted (see slope) with respect to the radial direction (up/down as seen in ‘Modified FIG. 1’ above).
Regarding claim 29, Hostettler discloses the drug delivery device according to claim 28, and Hostettler further discloses wherein the force provided by the energy member is converted into a radially directed force via the slide feature (see ), wherein the radially directed force acts onto the displaceable element (6a, see [0117]: force drives 6a out of engagement with 7).
Claims 17 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kemp (U.S. PGPUB No. 2016/0151585).
Regarding claim 17, Kemp discloses a drug delivery device comprising:
a housing element (2, see ‘Modified FIG. 1F’ below);
PNG
media_image3.png
344
768
media_image3.png
Greyscale
a release member (7) arranged axially movable (see [0064-0065]: 7 movable at least from a first extended position, FEP, to a retracted position, RP) with respect to the housing element (2);
a plunger rod (12) arranged axially movable (see [0072]: spring forces plunger to advance to subsequently move stopper distally to eject medicament) with respect to the housing element (2);
an energy member (9) configured to provide energy to induce an axial movement of the plunger rod in a distal direction (see [0072]); and
a displaceable element (8.2) being displaceable in a radial direction (see [0066]: 8.2 deflects radially inward==displaceable in radial direction under ramp 7.1 of release member 7),
wherein the drug delivery device has a first state in which (i) the release member (7) is movable in a proximal direction (see [0064-0065]: 7 movable at least from a first extended position to a retracted position) from a distal position (FEP) into a proximal position (RP) and (ii) the release member (7) is in the distal position (FEP) and arranged to hold the displaceable element (8.2) in a first radial position (see [0066]: 8.2 deflected radially inward== first radial position by ramp 7.1 of release member 7) to prevent a movement of the plunger rod (12) in the distal direction by the energy member (9, see [0066]: radial deflection ensures that syringe carrier cannot move until button 13 is pressed, see [0069]: spring 9 force released only after button 13 is pressed, and [0072]: plunger rod 12 moves distally only after spring 9 force is released),
wherein the drug delivery device is configured to be switched from the first state into a released state (after button 13 is pressed) by moving the release member from the distal position into the proximal position (see [0066] & [0069]: 7 moving from FEP to RP readies device for button 13 to be pressed), wherein in the released state (after button 13 is pressed) (i) the release member (7) is in the proximal position (RP) and no longer holds the displaceable element (8.2) in the first radial position (described in [0066]) which allows a movement of the displaceable element (8.2) from the first radial position (described in [0066]) into a second radial position (as seen in FIG. 6F, 8.2 horizontally aligned with longitudinal axis instead of at angle) to release the plunger rod (see [0069]) and (ii) the plunger rod (12) when released moves in the distal direction due to the energy provided by the energy member (see [0072]).
Regarding claim 21, Kemp discloses the drug delivery device according to claim 17, and Kemp further discloses comprising:
a transfer member (16, see FIGs. 2A-H) movably arranged with respect (see [0059]: 16 axially and rotationally movable with respect to housing 2) to the housing element (2), the transfer member (16) and the plunger rod (12) being operatively coupled such that a movement of the transfer member (16) in a first direction (see [0069]: 16 rotated in direction R to release spring force) is converted into a movement of the plunger rod (12) in the distal direction (see [0071-0072]: after release of spring force, plunger rod moves distally to deliver medicament),
wherein in the released state (after the button press), the energy member (9) provides a force onto the transfer member (16, see [0058-0059] and [0067]: spring 9 biases==provides force onto transfer member 16) in which the transfer member (16) moves in the first direction (rotation direction R) and thereby forces the plunger rod (12) to move axially in the distal direction (see [0069]: after the button press, 16 rotates under biasing force of the spring and the spring energy is then applied to carrier 8 which subsequently causes plunger to deliver medicament as in [0071-0072]).
Regarding claim 22, Kemp discloses the drug delivery device according to claim 21, and Kemp further discloses wherein in the released state (after button press), the transfer member (16, see FIG. 2D) is configured to move axially (along slot 17.3, see [0069]) with respect to the housing element (2) until the transfer member (16) contacts an end-stop (17.4, see FIG. 2E an [0071]: boss 18 of collar 16 stopped at 17.4 as in FIG. 2E and see [0058]: 16 comprises boss 18).
Regarding claim 23, Kemp discloses the drug delivery device according to claim 22, and Kemp further discloses wherein in the released state (after button press) and after the transfer member (16, see FIG. 2E) contacts the end-stop (17.4), the transfer member (16) is configured to rotate or continue to rotate (as shown in FIGs. 2F-H and described in [0073]: 16 rotates further to surface 17.5).
Regarding claim 24, Kemp discloses the drug delivery device according to claim 22, and Kemp further discloses wherein the end-stop (17.4, see FIG. 2E) comprises a friction reduction element (17.4 formed as a protrusion as shown in FIG. 2E and described in [0071]: transversal surface, aligning with applicant disclosure of the end stop friction reduction element in at least [0072]).
Regarding claim 25, Kemp discloses the drug delivery device according to claim 21, and Kemp further discloses wherein the transfer member (16, see FIG. 2A-H) is rotatably arranged (see [0059]: 16 axially and rotationally movable with respect to housing 2) with respect to the housing element (2), and the first direction is a rotational direction (see [0069]: 16 rotated in direction R to release spring force).
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783