DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/2/2026 has been entered.
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 15, 17-19 and 22-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fransson et al. (PG PUB 2017/0028135).
Re claim 15, Fransson discloses a plunger 1 (Fig 2-2b; it is noted that all reference characters cite below refer to Fig 2-2b unless otherwise noted) configured to transmit a force from an energy source to a piston of a medicament container (it is noted that the italicized text constitutes a functional limitation and, therefore, “a force”, “an energy source”, “a piston” and “a medicament container” are not a part of the claimed invention; rather, the plunger only has to be structurally capable of performing the recited function; this limitation is met in view of Fig 2), the plunger comprising: a plunger rod (from which each of legs 7 extend; best seen in Fig 4c and shaded in annotated Fig A below) configured to be displaced by the force in a distal direction (it is noted that the italicized text constitutes a functional limitation; this limitation is met in view of Para 35), the plunger rod comprising a body (labeled in Fig A below) extending along a longitudinal axis (extending vertically in Fig 2-2b), and the body comprising a proximal end (directed upward in Fig 2,2b) defining a central opening (the portion of channel 14 that extends vertically in Fig 2b; labeled in Fig B below) and a distal end (directed downward in Fig 2,2b); and a projection 7 provided in a proximal end region of the body and extending radially outward from the body (as seen in Fig 2; four legs 7 are provided – as shown in Fig 4c – any of these four legs 7 can read on the “projection”; for the sake of examination, the leg 7 extending downward in Fig 4c and annotated Fig A and out of the page in Fig 2a is interpreted as being the “projection”), wherein the projection comprises two protrusions 5,5 (a first of the protrusions can be any of the means 5 that extend clockwise from the projection 7 and a second of the protrusions can be any of the means 5 that extend counterclockwise from the projection 7; this is shown in visual in Fig C below) extending from a surface of the projection in a radially outward direction (as seen in Fig 2 and Fig 4c), and wherein the two protrusions are arranged circumferentially offset to each other relative to the body (as seen in Fig 2 and Fig C below).
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Re claim 17, Fransson discloses that the two protrusions are axially offset with respect to each other along the longitudinal axis (the first protrusion can be the proximal-most protrusion 5 extending clockwise from the projection 7 and the second protrusion can be the distal-most protrusion 5 extending clockwise from the projection 7).
Re claim 18, Fransson discloses that one protrusion of the two protrusions is arranged at a proximal end (directed upward in Fig 2) of the projection (the first protrusion can be the proximal-most protrusion 5 extending clockwise from the projection 7).
Re claim 19, Fransson discloses that one protrusion of the two protrusions is arranged at a distal end (directed downward in Fig 2) of the projection (the second protrusion can be the distal-most protrusion 5 extending counter-clockwise from the projection 7).
Re claim 22, Fransson discloses all the claimed features with the projection being a first projection, and wherein the plunger further comprises a second projection (as seen in Fig 4c, four legs 7 are provided and any of these legs except for the one directed downward in Fig 4c and out of the page in Fig 2b can read on the “second projection”; for the sake of examination, the leg 7 extending upward in Fig 4c and annotated Fig A above and into the page in Fig 2a is interpreted as being the “second projection”).
Re claim 23, Fransson discloses that the first and second projections are arranged radially opposite to each other on the body (as seen in Fig 4c and Fig A above).
Re claim 24, Fransson discloses a boss (the “boss” is labeled as “leg A” in annotated Fig C above for claims 24 and 25; the “boss” is any of the means 5 extending counter-clockwise from “leg A” in annotated Fig C above – this boss 5 would be in the upper right corner of Fig 4c – for claims 24 and 26) extending radially from the body (as seen in Fig 4c).
Re claim 25, Fransson discloses that a proximal end surface of the boss lies substantially on a same plane as a proximal end surface of the projection (since the boss and the projection are both legs 7, as explained in the rejection of claim 24 above).
Re claim 26, Fransson discloses that the boss comprises an angular surface that is sloped (as seen in Fig 4c, the radially-outermost surface of the boss 5 is angular and sloped in the circumferential direction).
Re claim 27, Fransson disclose that the plunger rod comprises a chamfered proximal edge (labeled in annotated Fig B above) at the proximal end (as seen in Fig 2b and Fig B above).
Re claim 28, Fransson discloses a side opening (any of the gaps 6 clockwise from the projection 7, as labeled in annotated Fig C above) on the body.
Re claim 29, Fransson discloses that the side opening extends axially along the longitudinal axis (as seen in Fig 2a and Fig C above).
Re claim 30, Fransson discloses that the side opening is arranged angularly offset with respect to the projection (as seen in Fig C, the first side opening is clockwise from the projection 7).
Re claim 31, Fransson discloses that a proximal portion of the side opening is arranged on a same circumference as a distal portion of the projection (as seen in Fig 4c, the side opening and the projection extend the same radial distance out from the body).
Re claim 32, Fransson discloses that the side opening is a first side opening (labeled in Fig C above), wherein the plunger further comprises a second side opening (extending counter-clockwise from the leg 7 labeled “leg A” in Fig C above), and wherein the first side opening and the second side opening are arranged radially opposite to each other on a distal section of the body (as explained above in relation to Fig C; additionally, the first side opening would be in the bottom left corner in Fig 4c and the second side opening would be in the upper right corner in Fig 4c).
Re claim 33, Fransson discloses a drug delivery device 100 (Fig 2; it is noted that all reference characters cited below refer to Fig 2-2b unless otherwise noted) comprising a plunger 1 (Fig 2-2b; it is noted that all reference characters cite below refer to Fig 2-2b unless otherwise noted) configured to transmit a force from an energy source to a piston of a medicament container (it is noted that the italicized text constitutes a functional limitation and, therefore, “a force”, “an energy source”, “a piston” and “a medicament container” are not a part of the claimed invention; rather, the plunger only has to be structurally capable of performing the recited function; this limitation is met in view of Fig 2), the plunger comprising: a plunger rod (from which each of legs 7 extend; best seen in Fig 4c and shaded in annotated Fig A above) configured to be displaced by the force in a distal direction (it is noted that the italicized text constitutes a functional limitation; this limitation is met in view of Para 35), the plunger rod comprising a body (labeled in Fig A above) extending along a longitudinal axis (extending vertically in Fig 2-2b), and the body comprising a proximal end (directed upward in Fig 2,2b) defining a central opening (the portion of channel 14 that extends vertically in Fig 2b; labeled in Fig B above) and a distal end (directed downward in Fig 2,2b); and a projection 7 provided in a proximal end region of the body and extending radially outward from the body (as seen in Fig 2; four legs 7 are provided – as shown in Fig 4c – any of these four legs 7 can read on the “projection”; for the sake of examination, the leg 7 extending downward in Fig 4c and annotated Fig A and out of the page in Fig 2a is interpreted as being the “projection”), wherein the projection comprises two protrusions 5,5 (a first of the protrusions can be any of the means 5 that extend clockwise from the projection 7 and a second of the protrusions can be any of the means 5 that extend counterclockwise from the projection 7; this is shown in visual in Fig C above) extending from a surface of the projection in a radially outward direction (as seen in Fig 2 and Fig 4c), and wherein the two protrusions are arranged circumferentially offset to each other relative to the body (as seen in Fig 2 and Fig C above).
Re claim 34, Fransson discloses that the medicament container is prefilled with a medicament or a drug (as set forth in the rejection of claim 33 above, the “medicament container” is not a part of the claimed invention since it is only functionally recited; in order to meet this limitation, the plunger only has to be functionally structured to operate with a container that is prefilled with a medicament or a drug; this limitation is met in view of Fig 2).
Re claim 35, Fransson discloses a boss (the proximal-most means 5 that extends counter-clockwise from the leg 7 labeled as “leg A” in Fig C above; this boss resides in the upper right corner of Fig 4c) extending radially from the body (as seen in Fig 4c), wherein a distal end of the boss is proximally offset relative to a distal end of the projection (as explained above, the “boss” is the proximal-most means 5 which is seen in Fig 2 as being proximal to the distal end of the projection).
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 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fransson et al. (PG PUB 2017/0028135) in view of Mirzazadeh et al. (PG PUB 2016/0166772).
Re claim 20, Fransson discloses all the claimed features except that the radial end of one protrusion of the two protrusions is shaped differently than a radial end of the other protrusion of the two protrusions. Mirzazadeh, however, teaches a plunger (Fig 24) comprising a body (the shaded portion labeled in Fig D below) that forms a plunger rod (as seen in Fig 24) and a projection 21 (three ribs 21 are shown in Fig 25; the “projection” is the rib 21 extending upward in Fig 24 and 25) extending radially outward from the body (as seen in Fig 25), wherein the projection comprises two protrusions 41,43 (labeled in Fig D below) extending from a surface of the projection in a radially outward direction (as seen in Fig 25, protrusion 41 extends leftward from the projection 21 and protrusion 43 extends rightward from the projection 21) and arranged circumferentially offset to each other relative to the body (as seen in Fig 25), wherein a first of the two protrusions has a radial end (labeled in Fig D below) that is shaped differently than a radial end (labeled in Fig D below) of a second of the two protrusions (as seen in Fig 25) for the purpose of providing a different resistance and/or a different feel or sound upon injection (Para 104). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fransson to include one of the two protrusions with a radial end that shaped differently than that of the other of the two protrusions, as taught by Mirzazadeh, for the purpose of providing a different resistance and/or a different feel or sound upon injection (Para 104).
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Re claim 21, Fransson discloses all the claimed features except that one of the two protrusions has a curved portion on a surface section that faces along a direction that is substantially tangential to an outer surface of the body toward the other of the two protrusions. . Mirzazadeh, however, teaches a plunger (Fig 24) comprising a body (the shaded portion labeled in Fig D below) that forms a plunger rod (as seen in Fig 24) and a projection 21 (three ribs 21 are shown in Fig 25; the “projection” is the rib 21 extending upward in Fig 24 and 25) extending radially outward from the body (as seen in Fig 25), wherein the projection comprises two protrusions 41,43 (labeled in Fig D below) extending from a surface of the projection in a radially outward direction (as seen in Fig 25, protrusion 41 extends leftward from the projection 21 and protrusion 43 extends rightward from the projection 21) and arranged circumferentially offset to each other relative to the body (as seen in Fig 25), wherein a first of the two protrusions has a curved portion (labeled in annotated Fig D above) on a surface section that faces along a direction that is substantially tangential to an outer surface of the body toward the other of the two protrusions (as seen in Fig D above) for the purpose of providing a different resistance and/or a different feel or sound upon injection (Para 104). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fransson to include one of the two protrusions with a curved portion on a surface section that faces along a direction that is substantially tangential to an outer surface of the body toward the other of the two protrusions, as taught by Mirzazadeh, for the purpose of providing a different resistance and/or a different feel or sound upon injection (Para 104).
Response to Arguments
Applicant’s arguments filed 1/2/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, neither the Hansson nor Iwasaki references used to reject the claims in the last Office Action are applied in the present Office Action.
Conclusion
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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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