DETAILED ACTIONS
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to adequately show the needle shield remover 4 and the needle shroud 11 as described in the specification. Although these reference characters are included in Fig 1, the drawings do not clearly show these features; specifically, reference character 11 appears to point to an empty space while reference characters 4 appears to point only to a flexible arm. Based on these drawings, a proper understanding of the structure of the needle shield remover and the needle shroud and their relationship with the other elements of the invention cannot be achieved. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
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.
Claim Objections
Claims 28, 29 and 31 are objected to because of the following informalities: Claim 28 recites “an end needle shield remover position” and claims 29 and 31 refer to this position. However, since claim 17 has been amended to recite that the needle shield remover has a “rotational end position” (see the last line of claim 17), claim 28 should be amended to recite “[[an]] the rotational end position of the needle shield remover rotational end position of the needle shield remover needle shield remover position” and claim 28 could be amended to recite “[[an]] the end needle shield remover position”. Appropriate correction is required.
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 20 and 29 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.
Claim 20 recites that “the needle shield remover is a part of a cap assembly” and “is assembled with a cap” and depends on claim 19 that states that “the needle shield remover is a cap”. Since claim 20 requires the needle shield remover to be assembled with a cap but claim 19 requires the needle shield remover to be a cap, it is unclear how the limitation of claim 20 can be met along with the limitation of claim 19 since they appear to be contrary to each other. For the sake of examination, claim 20 is interpreted as reciting dependence on claim 17 instead of claim 19. In order to overcome this rejection, it is suggested to amend claim 20 in this manner.
Claim 29 requires the rotation angle of the reservoir between its initial position and its end position to be the same angle as that of the needle shield remover between its initial position and its end position (“the first angle is equal to the second angle”). However, this is contrary to claim 17 which has been amended to require the reservoir to have a rotation angle less than that of the needle shield remover (“the rotation of the reservoir […] is blocked by a rotation slop […] before the needle shield remover has reached its end position”). Because claim 29 is contrary to claim 17, it does not appear that the limitation of claim 29 can be met if the limitation of claim 17 is met. Therefore, claim 29 cannot be further examined on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-23, 26, 28, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dowds et al. (PG PUB 2014/0025013).
Re claim 17, Dowds discloses an arrangement 50+60 (Fig 1; wherein the needle shield remover 50 has the configuration of that seen in Fig 20-24) for a drug delivery device (it is noted that the italicized text constitutes a functional limitation and, therefore, a “drug delivery device” is not a part of the claimed invention; this limitation is met in view of Fig 1-3 that shows that the arrangement is part of a device), the arrangement comprising: a housing 60 (Fig 1) with a proximal end (to the right in Fig 1) and a distal end (to the left in Fig 1); a needle shield remover 50 (Fig 1,23) configured to be rotationally locked to a needle shield covering a needle (it is noted that the italicized text constitutes a functional limitation and, therefore, a “needle shield” and “a needle” are not a part of the claimed invention; this limitation is met in view of Para 63 that sets forth that the remover 50 is rotationally locked to the syringe 20 and the shield 40 is rotationally locked to the syringe 20 during a beginning part of shield removal), wherein the needle shield remover is releasably connected or releasably connectable to the housing (Para 65); and a guiding interface 66 (Fig 24), wherein the guiding interface is configured such that, when the needle shield remover rotates with respect to the housing from a state in which the needle shield remover is connected to the housing, the guiding interface guides a movement of the needle shield remover relative to the housing in a direction away from the proximal end of the housing to disconnect the needle shield remover from the housing (as the cam follower 56 of the remover 50 moves along the sloped surface 67 (seen in Fig 24, labeled in Fig 15) of the guiding interface, Para 57,64), wherein the movement of the needle shield remover relative to the housing to disconnect the needle shield remover from the housing comprises an axial movement and a rotational movement of the needle shield remover relative to the housing (Para 64), wherein the housing is configured to receive a reservoir or the reservoir is received in the housing (it is noted that the italicized text constitutes a functional limitations, resulting in the arrangement of the claim not requiring a “reservoir”; and the use of the term “or” also sets forth that a “reservoir” is not required; this limitation is met in view of Fig 2), (as set forth above, the “reservoir” is not a part of the claimed invention; therefore, the claimed arrangement only has to be structurally capable of interacting with a hypothetical reservoir such that it results in the hypothetical reservoir operating in the manner recited below) wherein the reservoir comprises a reservoir body with an interior region that is configured to retain a medicament and the needle for providing a fluid communication between the interior region of the reservoir body and an exterior portion of the reservoir body, and wherein the needle is covered by the needle shield (as set forth above, none of the “reservoir”, “needle” nor “needle shield” are a part of the claimed invention; these limitations are met in view of Fig 25), wherein the reservoir is configured such that, when the needle shield remover is being disconnected from the housing, the reservoir can rotate together with the needle shield remover relative to the housing from an initial reservoir position (when the cam follower 56 is in the position seen in Fig 24) relative to the housing to an end reservoir position relative to the housing (when the cam follower 56 has rotated to the reach the intersection of the horizontal and sloped surfaces of the guiding interface, labeled in Fig A below; Para 65 sets forth that the remover disconnects from the reservoir when it reaches the point of intersection labeled below and, therefore, this is where rotation of the reservoir stops), and wherein the rotation of the reservoir relative to the housing during the disconnection of the needle shield remover from the housing is blocked by a rotational stop of the arrangement (the “rotational stop” being the end of the sloped surface that forms the intersection with the horizontal surface, labeled in Fig A below), before the needle shield remover has reached its rotational end position relative to the housing (Para 65 sets forth that rotation of the syringe stops when the cam follower 56 reaches the intersection labeled in Fig A below but the remover continues to rotate while the cam follower 56 travels down the sloped surface 67).
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Re claim 18, Dowds discloses that the axial and rotational movements of the needle shield remover relative to the housing occur simultaneously (Para 64).
Re claim 19, Dowds discloses that the needle shield remover is a cap (it is a “cap” in that it is located on one end of the housing, as seen in Fig 1).
Re claim 20, Dowds discloses that the needle shield remover is a part of a cap assembly 150+158 (Fig 18B) in which the needle shield remover is assembled with a cap 158 (Fig 18B) and is rotationally locked to the cap (Para 55).
Re claim 21, Dowds discloses that the guiding interface defines a rotational direction for a rotation required to disconnect the needle shield remover from the housing (Para 64).
Re claim 22, Dowds discloses that the guiding interface is configured such that a rotation in only one direction is permitted to disconnect the needle shield remover from the housing (Para 64).
Re claim 23, Dowds discloses that the guiding interface comprises at least one guide track (comprising the horizontal surface and the sloped surface 67 labeled in Fig A above) that is configured to guide the movement of the needle shield remover relative to the housing when the needle shield remover is disconnected from the housing (Para 57,64).
Re claim 26, Dowds discloses that the reservoir, when received in the housing, is axially secured relative to the housing, and wherein an axial position of the reservoir relative to the housing does not change when the needle shield remover is being disconnected from the housing (as set forth above, the “reservoir” is not a part of the claimed invention; this limitation is met in view of Para 65).
Re claim 28, Dowds discloses that the needle shield remover is configured such that, when the needle shield remover is disconnected from the housing, the needle shield remover rotates from an initial needle shield remover position (the position when the cam follower 56 is in the position seen in Fig 24) relative to the housing to an end needle shield remover position (the position when the cam follower has reached the distal end of the sloped surface 67) relative to the housing (Para 57,64).
Re claim 31, Dowds discloses that a rotation angle of the reservoir between the initial reservoir position and the end reservoir position is a first angle (as set forth above, the “reservoir” is not a part of the claimed invention), wherein a rotation angle of the needle shield remover between the initial needle shield remover position and the end needle shield remover position is a second angle, and wherein the first angle is less than the second angle (Para 65 sets forth that rotation of the syringe stops when the cam follower 56 reaches the intersection labeled in Fig A above but the remover continues to rotate while the cam follower 56 travels down the sloped surface 67).
Re claim 33, Dowds discloses a drug delivery device (all of the components of device 10 except for the prefilled syringe 20, its attached needle 24 and shield 40, Fig 1-3) comprising an arrangement 60+50 (Fig 1; wherein the needle shield remover 50 has the configuration seen in Fig 20-24), the arrangement comprising: a housing 60 (Fig 1) with a proximal end (to the right in Fig 1) and a distal end (to the left in Fig 1); a needle shield remover 50 (Fig 1,23) configured to be rotationally locked to a needle shield covering a needle (it is noted that the italicized text constitutes a functional limitation and, therefore, a “needle shield” and “a needle” are not a part of the claimed invention; this limitation is met in view of Para 63 that sets forth that the remover 50 is rotationally locked to the syringe 20 and the shield 40 is rotationally locked to the syringe 20 during a beginning part of shield removal), wherein the needle shield remover is releasably connected or releasably connectable to the housing (Para 65); and a guiding interface 66 (Fig 24), wherein the guiding interface is configured such that, when the needle shield remover rotates with respect to the housing from a state in which the needle shield remover is connected to the housing, the guiding interface guides a movement of the needle shield remover relative to the housing in a direction away from the proximal end of the housing to disconnect the needle shield remover from the housing (as the cam follower 56 of the remover 50 moves along the sloped surface 67 (seen in Fig 24, labeled in Fig 15) of the guiding interface, Para 57,64), wherein the movement of the needle shield remover relative to the housing to disconnect the needle shield remover from the housing comprises an axial movement and a rotational movement of the needle shield remover relative to the housing (Para 64), wherein the housing is configured to receive a reservoir or the reservoir is received in the housing (it is noted that the italicized text constitutes a functional limitations, resulting in the arrangement of the claim not requiring a “reservoir”; and the use of the term “or” also sets forth that a “reservoir” is not required; this limitation is met in view of Fig 2), (as set forth above, the “reservoir” is not a part of the claimed invention; therefore, the claimed arrangement only has to be structurally capable of interacting with a hypothetical reservoir such that it results in the hypothetical reservoir operating in the manner recited below) wherein the reservoir comprises a reservoir body with an interior region that is configured to retain a medicament and the needle for providing a fluid communication between the interior region of the reservoir body and an exterior portion of the reservoir body, and wherein the needle is covered by the needle shield (as set forth above, none of the “reservoir”, “needle” nor “needle shield” are a part of the claimed invention; these limitations are met in view of Fig 25), wherein the reservoir is configured such that, when the needle shield remover is being disconnected from the housing, the reservoir can rotate together with the needle shield remover relative to the housing from an initial reservoir position (when the cam follower 56 is in the position seen in Fig 24) relative to the housing to an end reservoir position relative to the housing (when the cam follower 56 has rotated to the reach the intersection of the horizontal and sloped surfaces of the guiding interface, labeled in Fig A below; Para 65 sets forth that the remover disconnects from the reservoir when it reaches the point of intersection labeled below and, therefore, this is where rotation of the reservoir stops), and wherein the rotation of the reservoir relative to the housing during the disconnection of the needle shield remover from the housing is blocked by a rotational stop of the arrangement (the “rotational stop” being the end of the sloped surface that forms the intersection with the horizontal surface, labeled in Fig A below), before the needle shield remover has reached its rotational end position relative to the housing (Para 65 sets forth that rotation of the syringe stops when the cam follower 56 reaches the intersection labeled in Fig A below but the remover continues to rotate while the cam follower 56 travels down the sloped surface 67).
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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.
Claims 32, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Dowds et al. (PG PUB 2014/0025013) in view of Bitdinger et al. (US Pat 5,478,316).
Re claim 32, Dowds discloses a plunger rod 22 (Fig 1,2) but does not disclose an energy storage member having energy stored therein, wherein the energy, when released, drives the plunger rod in a distal direction relative to the housing. Bitdinger, however, teaches an arrangement (Fig 1-4) comprising a housing 12 (Fig 1-4), a needle shield remover 16 (Fig 1-4), a plunger rod 46 (Fig 3,4), and an energy storage member 56 (Fig 3,4; “constant force spring” – Col 4, Line 9) having energy stored therein that, when released, drives the plunge rod in a distal direction relative to the housing (Col 4, Lines 9-10) for the purpose of providing a drug delivery device that allows for self-administration of medicine in a safe, reliable, and non-traumatic manner (Col 1, Lines 55-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Dowds to include an energy storage member that drives the piston rod, as taught by Bitdinger, for the purpose of allowing for self-administration in a safe, reliable and non-traumatic manner (Col 1, Lines 55-57).
Re claim 34, Dowds discloses all the claimed features except that the drug delivery device comprises an autoinjector. Bitdinger, however, teaches a drug delivery device (Fig 1-4) comprising a housing 12 (Fig 1-4) and a needle shield remover 16 (Fig 1-4), wherein the drug delivery device comprises an autoinjector (Col 1, Lines 6-8) for the purpose of allowing for self-administration in a safe, reliable and non-traumatic manner (Col 1, Lines 55-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Dowds to include the drug delivery device as an autoinjector, as taught by Bitdinger, for the purpose of allowing for self-administration in a safe, reliable and non-traumatic manner (Col 1, Lines 55-57).
Re claim 35, Boyd discloses that the drug delivery device includes the reservoir (as seen in Fig 1-3) filled with a drug (“prefilled” and “injecting medication”, Para 40).
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claim 24 could not be found in combination with the subject matter of independent claim 17. Dependent claim 24 requires the arrangement to include a second guiding interface (in addition to the first guiding interface of claim 17), wherein the second guiding interface guides movement of the needle shield remover in a rotational direction opposite to the rotational direction of the movement of the needle shield remover caused by the first guiding interface of claim 17. A second guiding interface as claimed is not disclosed by Dowds, nor would it have been obvious to one of ordinary skill in the art to modify Dowds to include such a second guiding interface since (a) Dowds allows for rotational movement of the needle shield remover only in one rotational direction and (2) modifying Dowds to include such a second guiding interface that requires movement in a second rotational direction would not appear to serve any purpose.
Double Patenting
The amendments to claims 17 and 33 filed 6/29/2026 overcome the nonstatutory double patenting rejections in view of U.S. Patent No. 12,514,982 and the provisional nonstatutory double patenting rejections in view of copending Application No. 19/404,414.
Response to Arguments
Applicant's arguments filed 6/29/2026 have been fully considered.
The argument directed to the Drawing objection (set forth in the last Office Action and maintained in the present Office Action) is simply a general allegation that “a person of ordinary skill in the art would readily understand the claimed invention in reading the specification in combination with the figures” and “thus, no further detail of the needle shield remover 11[sic] and the needle shroud 11 is required to be shown”. The Examiner respectfully disagrees and maintains the objection because, as stated above, the needle shield remover 4 is only indicated in the drawings by a single arrow that appears to point to a cross-section of an arm and the needle shroud 11 is only indicated in the drawings by a single arrow that appears to point to a cross-section of an empty space. Because the full structure of the needle shield remover 4 and the needle shroud 11 are not shown in the drawings, it would be unclear to one of ordinary skill in the art how the needle shield remover and the needle shroud 11 are structurally configured and functionally able to perform the actions recited in the claims.
Due to the amendments made to the independent claims, the closest prior art of record is now Dowd. Since Donald and James are no longer used in the present rejections, the arguments directed to the modification of each of these references by Dowd are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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