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 .
Response to Amendment
This office action is responsive to the amendment filed on 04/29/2026. As directed by the amendment: claims 1-19 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-19 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Office Action mailed on 02/03/2026. The 112(f) interpretations have been maintained and are updated to reflect the amendments.
Response to Arguments
Applicant's arguments, see p. 9-13 of “Remarks” filed 04/29/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument on p. 9-10 that Holmqvist fails to disclose or teach a safety mechanism as claimed or the presently claimed sequence of safety removal followed by plunger rod release, the examiner respectfully disagrees. The applicant argues “rectangular arm 228 [cited as the safety mechanism] in Holmqvist does not act as a removable or disengageable safety interlock. It is not moved out of contact with the plunger rod as a discrete preliminary step; but rather, it remains part of the mechanical system governing sequential release throughout the dose delivery sequence” and “there is no disclosure of a distinct preliminary step in which a safety mechanism is first removed, followed by a separate release action”. This argument is not persuasive firstly because the elongated, rectangular arm 228 does anticipate a safety mechanism as interpreted under 112(f) as it is an elongated, rectangular pin-like structure that is inserted into the plunger rod segment 1783 to prevent release thereof and is both removable and disengageable from the plunger rod segment 1783 as seen in Fig. 27 where arm 228 is fully removed and disengaged from said segment 1783 (see para. 0055). Secondly, examiner notes claim 1 does not explicitly disclose a distinct preliminary step followed by a separate release step as claim 1 as the functional limitations lack language explicitly limiting order such as “after” or “subsequently”. The only claimed order is indicated with the functions occurring when the device is pressed against an injection site. However, Holmqvist still anticipates the claim limitations if order was implied as the device is first pressed against the injection site which causes the needle cover 136 to displace which subsequently acts on the arm 228 to move said arm 228 out of contact with the plunger rod 178 (see para. 0056-0058). After the arm 228 has been moved out of contact with the plunger rod segment 1783, the segmented release of the remaining two plunger rod segments occurs which causes the plunger rod 178 to act on the medicament container stopper (132) for delivery of the medicament (see para. 0059). Thus, Holmqvist does anticipate the safety mechanism and its relationship with the activator and plunger rod as claimed and the sequence of safety removal followed by plunger rod release.
Therefore, the rejection of claim 1 is maintained.
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:
“a safety mechanism” in claims 1, 6, and 8,
“release members” in claims 2, 6, and 8,
“an intermediary release member” in claim 6,
“locking features” in claim 9,
“flexible locking members” in claim 10,
“support members” in claim 13,
“audible/tactile member” in claim 14,
“flexible members” in claim 19.
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.
Regarding “a safety mechanism” in claims 1, 6, and 8, 112(f) is invoked because: (i) it uses a generic placeholder (mechanism) (ii) it is coupled with functional language (safety), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 12, Fig. 37-38 and p.3, lines 9-12 disclose “the safety mechanism may comprise a safety pin.” Examiner is interpreting the limitation as a safety pin or equivalent elongated structure preventing release of the plunger rod.
Regarding “release members” in claims 2, 6 and 8, 112(f) is invoked because: (i) it uses a generic placeholder (members), (ii) it is coupled with functional language (release), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 12, Fig. 38, p.12, lines 8-11 and p.14, lines19-28 discloses the release sleeve (72) comprises ledges (82) as seen in Fig. 12 or wedges (166) seen in Fig. 38 on an inner surface of a front section of the release sleeve (72) which act as release members to push the legs (108) of the trigger (104) in a radial direction. Examiner is interpreting this limitation as a ledge, wedge, or an equivalent structure.
Regarding “an intermediary release member” in claim 6, 112(f) is invoked because: (i) it uses a generic placeholder (member), (ii) it is coupled with functional language (intermediary release), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 14 and p. 9, lines 7-12 disclose the intermediary release member as a trigger (104) comprising “a cylindrical body 106 with forwardly directed legs 108, where the free ends of the legs are arranged with outwardly directed ledges 110. The trigger is positioned such that the ledges 110 in the initial position are in contact with the outer surfaces of the plunger rod hooks 102.” Examiner is interpreting this limitation as a cylindrical trigger that is structured to interact with the plunger rod when actuated by the release members of the release sleeve.
Regarding “locking features” in claim 9, 112(f) is invoked because: (i) it uses a generic placeholder (features), (ii) it is coupled with functional language (locking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 10, Fig. 37, and p.3, lines 30-34 disclosing “the locking members may comprise openings” with the spring housing comprising flexible locking members arranged to flex into the openings. Examiner is interpreting this limitation as openings that are capable of locking the release sleeve and the needle cover in the forward direction or an equivalent structure.
Regarding “flexible locking members” in claim 10, 112(f) is invoked because: (i) it uses a generic placeholder (members), (ii) it is coupled with functional language (flexible locking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig.8, Fig. 35, and p.7, lines 23-26 disclose “the front area of the spring housing 48 is further provided with flexible arms 56 extending in the forward direction, where the free ends of the flexible arms 56 are provided with outwardly extending lock-out hooks 58.” Examiner is interpreting this limitation as flexible arms or an equivalent flexible structure capable of flexing into said openings of the release sleeve.
Regarding “support members” in claim 13, 112(f) is invoked because: (i) it uses a generic placeholder (members), (ii) it is coupled with functional language (support) and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 8, Fig. 35, p. 7, lines 13-21, and p. 14, lines 33-34 – p.15, lines 1-3 discloses the spring housing comprises forwardly extending features (54) or forwardly protruding ribs as seen in Fig. 8 or forwardly-protruding flexible wings (174) which contact the rear surface of the flange of the syringe (24) in order to avoid rattling syringe (24) inside the device prior to activation. Examiner is interpreting this limitation as a forwardly protruding structure of the spring housing that contacts the rear surface of the flange of the syringe or an equivalent structure.
Regarding “audible/tactile member” in claim 14, 112(f) is invoked because: (i) it uses a generic placeholder (member), (ii) it is coupled with functional language (audible/tactile), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 19-21 and p.10, lines 24-31 disclose a signaling member (150) may press-fitted onto the features (54) at the forward end of the spring housing (48), and the signaling member (150) is a ring-shaped body (152) with tongues (156) that slid along the coils of the drive spring (96) to produce a clicking sound. Fig. 35 and p.14, lines 33-34 – p.15, lines 1-7 disclose the spring housing (48) is further provided with a “so-called click sheet 172” which is operably connected to the spring housing (48) front plates (170) and comprises click tongues (176) that have the same function as the previously described tongues (156). Examiner is interpreting this limitation as a ring-like structure or an equivalent structure that is capable of creating audible/tactile information to a user.
Regarding “flexible members” in claim 19, 112(f) is invoked because: (i) it uses a generic placeholder (members), (ii) it is coupled with functional language (flexible), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 16-18, Fig. 39, p.10, lines 7-10, and p. 15, lines 10-12 disclose the cap (126) comprises a flexible arm with an inwardly directed protrusion (134 in Fig. 18 and 184 in Fig. 39) that fit into the recesses (15) of the body (12). Examiner is interpreting this limitation as an inwardly protruding structure that is flexible such that it can fit into a recess of the body to releasably hold the cap to said body.
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.
Claim(s) 1-5, 7, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmqvist (U.S Patent Pub. No. 20170119972 A1).
Regarding claim 1, Holmqvist discloses (Claim 1) A medicament delivery device (see Fig. 11-29, examiner notes Holmqvist uses proximal as the direction closest to the injection site and distal as closer to the user, examiner will be using the standard convention as distal as the direction closest to the injection site and proximal as closer to the user) comprising:
a body (110 in Fig. 11);
a medicament container (120 in Fig. 11) provided with a medicament delivery member (128 in Fig. 12) disposed in the body (110, see Fig. 12);
a drive unit comprising a plunger rod (178 in Fig. 16b-17) and a drive spring (194, 210, 230 in Fig. 20-21, see para. 0048 – the plunger rod 178 is comprised of 3 discrete segments together interpreted as the claimed plunger rod, see para. 0055 – drive springs 194, 210, 230 are interpreted as the claimed drive spring for acting on the segments of the plunger rod 178), said drive unit operatively connected to said medicament container (see Fig. 12 and para. 0048);
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an activator (136 in Fig. 11, 216 in Fig. 21) operatively connected to said drive unit (see Fig. 21 and para. 00048 – the end segment 216 seen in Fig. 21 and annotated more clearly below in Holmqvist annotated drawing 1 below is being interpreted as the release sleeve which forms part of the activator, see para. 0056 – the delivery member guard 136 is being interpreted as the needle cover which forms part of the activator); and
a safety mechanism (228 in Fig. 21) operatively connected to said plunger rod (178, examiner notes the safety mechanism is being interpreted under 112(f) as a safety pin or equivalent elongated structure preventing release of the plunger rod, see Fig. 21, para. 0053, and 0055 – the elongated, rectangular arm 228 is being interpreted as a safety pin as it has an elongated, rectangular pin structure that prevents release of the plunger rod segment 1783),
wherein in an initial state of the device, said plunger rod (178) is held with said drive spring (194, 210, 230) in a tensioned state and said safety mechanism (228) is in contact with and prevents release of said plunger rod (178, see Fig. 23 and para. 0055),
when the device is pressed against an injection site (see para. 0056), said activator (136, 216) acts on said safety mechanism (228) for moving said safety mechanism (228) out of contact with said plunger rod (178), and said activator (136, 216) acts on said plunger rod (178) for releasing said plunger rod (178), causing said plunger rod (178) to act on said medicament container (120) for delivery of medicament at said injection site (see Fig. 23 for initial state and Fig. 27 for end of delivery state, see para. 0056-0059 – needle cover 136 displaces proximally to create a series of displacements which unlocks the three segments of plunger rod 178 such that the release sleeve 216 displaces proximally to remove the safety pin 228 out of contact with plunger rod segment 1783 which releases the plunger rod 1783 and the remaining segments to move under the urging of the drive springs 194, 210, and 230 to act on the medicament container 120 for delivery).
Regarding claim 2, Holmqvist discloses (Claim 2) the medicament delivery device according to claim 1, wherein said activator (136, 216) comprises a release sleeve (216 in Fig. 21) provided with release members (214 in Fig. 21) that are moved to act on said plunger rod (178) for releasing said plunger rod (178, examiner notes the release members are being interpreted under 112(f) as a ledge, wedge, or equivalent structure, see Fig. 21, 23, and para. 0052 and 0057 – release sleeve 216 comprises recesses 214 which as seen in Fig. 23 form a wedge-shaped recess for the protrusions 212 of the plunger rod 178, the recesses 214 are moved proximally to act on said plunger rod 178 for unlocking the plunger rod third segment 1783 from its engagement with the release sleeve 216 such that release sleeve 216 can then move relatively proximally to release the plunger rod 178 from safety pin 228).
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Regarding claim 3, Holmqvist discloses (Claim 3) the medicament delivery device according to claim 2, wherein said plunger rod (178) comprises flexible arms (see Fig. 21, annotated Holmqvist annotated drawing 2 below, and para. 0050 – plunger rod segment 1783 comprises two flexible arms 204 on either side of the slit 202, see para. 0048 and 0055 – the two arms of the plunger rod segments are flexible in the radial direction),
the flexible arms (204) comprising protrusions (212 in Fig. 21) that cooperate with ledges (ledges of 214) fixed in the device (see annotated Holmqvist drawing 3 below for ledges, see Fig. 23 and para. 0057 – the release members formed by the wedge-shaped recesses 214 comprises ledges on its proximal and distal ends that are fixed in the device in its initial state and said ledges cooperate with the protrusions 212),
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wherein said release members (214) act on said protrusions (212) for flexing said arms (204) to release said plunger rod (178, see para. 0057-0058 – the recesses 214 are moved proximally to disengage the protrusions 212 which allows the release sleeve 216 to move proximally and remove the safety pin 228 which allows the arms 204 to flex which leads to a chain reaction with the plunger rod segments for releasing the plunger rod 178).
Regarding claim 4, Holmqvist discloses (Claim 4) the medicament delivery device according to claim 3, wherein said safety mechanism (228 in Fig. 21 and 23) comprises a safety pin between with said flexible arms (204), preventing release of said plunger rod (178, see annotated Holmqvist drawing 2 above for arms 204, see Fig. 23, para. 0053, and 0055 – the elongated, rectangular arm 228 is being interpreted as a safety pin as it has an elongated, rectangular pin structure that is located between the arms 204 preventing release of the plunger rod segment 1783.
Regarding claim 5, Holmqvist discloses (Claim 5) the medicament delivery device according to claim 4, wherein said safety pin (228) is comprised in said release sleeve (216, see annotated Holmqvist drawing 1 above and Fig. 21 – safety pin 28 is comprised in the end segment 216), the safety pin (228) being designed to move out of contact with the arms (204) of the plunger rod (178) when the release members (214) are moved to act on the protrusions (212) of the plunger rod (178, see Fig. 24 and para. 0057-0058 – safety pin 228 moves out of contact with arms 204 of plunger rod segment 1783 when the recesses 214 are moved proximally to disengage the protrusions 212).
Regarding claim 7, Holmqvist discloses (Claim 7) the medicament delivery device according to claim 3, wherein the activator (136, 216) further comprises a needle cover (136 in Fig. 12 and 14) configured to be moved into said body (110), thereby moving said release sleeve (216, see para. 0056-0057– body 110 moves distally relative to needle cover 136 and thus needle cover 136 moves proximally into said body 110 which indirectly causes the release sleeve 216 to move proximally).
Regarding claim 17, Holmqvist discloses (Claim 17) the medicament delivery device according to claim 1, further comprising a cap (232 in Fig. 11) attachable to a front end of the device (see Fig. 12 and para. 0054), said cap (232) comprising flexible hooks (236 in Fig. 11) engaging a needle shield (130 in Fig. 11) covering said medicament delivery member (128, see para. 0054), wherein removal of said cap (232) removes said needle shield (130, see para. 0055).
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.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist in view of Andre et al. (U.S Patent Pub. No. 20200289753 A1, “Andre”).
Regarding claim 15, Holmqvist discloses the device of claim 1, as discussed above. Holmqvist further discloses the limitations of (Claim 15) further comprising a syringe holder (126 in Fig. 11 and para. 0042).
Holmqvist fails to disclose (Claim 15) said syringe holder comprising openings surrounded by support surfaces, wherein said body is provided with openings, wherein said support surfaces are configured to snap into said openings of said body, thereby attaching said syringe holder to said body.
Andre discloses a medicament delivery device (see Fig 23-40) comprising a body (300 in Fig. 23) and a syringe holder (314 in Fig. 23, see para. 0049), wherein Andre teaches (Claim 15) said syringe holder (314) comprising openings (316 in Fig. 23) surrounded by support surfaces (see Fig. 23, para. 0049– the syringe holder 314 comprises cut-outs 316 which are surrounded by surfaces of the tongue 312 interpreted as the support surface), wherein said body (300 in Fig. 23) is provided with openings (308 in Fig. 23, see para. 0049), wherein said support surfaces are configured to snap into said openings (308) of said body (300, see Fig. 24 and para. 0049 – the surfaces of tongue 312 surrounded openings 316 fit into the openings 308 of the body 300 such that they are configured to snap into the openings 308 when tongue 312 is fit into the opening 308), thereby attaching said syringe holder (314) to said body (300, see Fig. 24 and para. 0049).
Since the syringe holder (126) of Holmqvist is disclosed as being supported on a ledge (122) of the body (110, see para. 0042), and Andre discloses a tongue of the syringe holder and opening of the body engaging to rotationally and axially lock the two structures together (see para. 0049), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe holder and body taught by Holmqvist to incorporate the tongue and opening, respectively, as taught by Andre. Andre teaches that such an engagement locks the syringe holder to the housing both rotationally and axially (see para. 0049), which would be advantageous in Holmqvist to prevent rotation of the syringe holder when surrounding elements rotate.
Regarding claim 16, modified Holmqvist discloses the device of claim 15, as discussed above.
However, modified Holmqvist is silent to (Claim 16) said syringe holder further comprises a seat designed for supporting a flange at a rear end of said medicament container.
Andre teaches (Claim 16) said syringe holder (314) further comprising a seat (324 in Fig. 23) designed for supporting a flange (326 in Fig. 23) at a rear end of said container (318, see Fig. 23 and para. 0049 – support surfaces 324 form a seat as seen in Fig. 23 for a flange 326 at proximal end of container 318).
Since the container (120) of Holmqvist is illustrated with a flange (see Fig. 11) at its proximal end, and Andre teaches the syringe holder (314) having a seat for the flange (326) of the container (318), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe holder taught by Holmqvist to incorporate the seat as taught by Andre. Andre teaches that the syringe holder having surface that form a seat to support the flange of the container and thus would prevent the container from moving distally within the holder (see para. 0049).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist in view of Knight et al. (U.S Patent Pub. No. 20200188607 A1, “Knight”).
Regarding claim 18, Holmqvist discloses the device of claim 17, as discussed above. However, Holmqvist fails to disclose (Claim 18) wherein said cap further comprises flexible hooks at a front area of the cap for holding said needle shield after removal.
Knight discloses a cap (40 in Fig. 1-2) for a medicament delivery device (10), wherein the cap (40) comprises flexible hooks (58a-58d in Fig. 8) for engaging a needle shield (19 in Fig. 8, see para. 0123-0124 – elastic legs 58a-58d have internally facing barbs 57a-57c such that the legs forms flexible hooks). Knight teaches, in addition to the flexible hooks (58a-58d), (Claim 18) said cap (40) further comprises flexible hooks (55a-55b in Fig. 7a and 8) at a front area (distal end of 40) of the cap (40) for holding said needle shield (19) after removal (see para. 0123-0124 – elastic legs 55a-55b are formed at a distal end of remover 56 and thus at a distal area of the cap 40, elastic legs 55a-55b have barb tips 64a-64d that engage with the cap 40 to thus hold the remover 56 and needle shield 19 within the cap 40 after removal).
Since Holmqvist discloses a cap (232) having a remover (234) with flexible hooks (236) for engaging the needle shield (130, see Fig. 12 and para. 0054), and Knight discloses a cap (40) having a remover (56) with flexible hooks (58a-58d) for engaging the needle shield (19, see para. 0123-0124), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap taught by Holmqvist to incorporate flexible hooks at a front area of the cap for holding said needle shield after remove as taught by Knight. Knight teaches that two sets of flexible hooks allows one set to grip the needle shield and the second set to secure the needle shield within the cap ensuring all relevant components remove together (see para. 0124).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist in view of Schrul et al. (U.S Patent Pub. No. 20190151564 A1, “Schrul”).
Regarding claim 18, Holmqvist discloses the device of claim 17, as discussed above. However, Holmqvist fails to disclose (Claim 19) wherein said cap is provided with flexible members cooperating with said body for releasably holding said cap to said body.
Schrul discloses a cap (20 in Fig. 1) releasably held onto the body (1 in Fig. 3) of a medicament delivery device (see para. 0062), wherein Schrul teaches (Claim 19) wherein said cap (20 in Fig. 1) is provided with flexible members (22 in Fig. 3b) cooperating with said body (1) for releasably holding said cap (20) to said body (1, examiner is interpreting the flexible members under 112(f) as an inwardly protruding structure that is flexible such that it can fit into a recess of the body to releasably hold the cap to said body, see Fig. 5b-7b and para. 0031 and 0062 – cap 20 comprises an engaging element 22 for releasably holding cap 20 to body 1, engaging element 22 is an inwardly protruding structure as seen in Fig. 3b that can snap fit into a counter-engaging element of the housing 1 such that it is flexible in order to snap fit).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap taught by Holmqvist to incorporate flexible members cooperating with said body for releasably holding said cap to said body as taught by Schrul. Schrul teaches such an engagement allows the cap to be releasably held onto the body securely preventing accidental removal (see para. 0012 and 0062).
Allowable Subject Matter
Claims 6 and 8-14 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is Holmqvist (U.S Patent Pub. No. 20170119972) and Andre et al. (U.S Patent Pub. No. 20200289753).
Holmqvist discloses the device of claims 1-3, as discussed above. Regarding claim 6, Holmqvist fails to disclose an intermediary release member that is in contact with the protrusions (212) of the plunger rod (178). While Holmqvist does disclose several intermediary members such as rotator (148 in Fig. 11) and actuator (154 in Fig. 11), there is no other structure that contacts the protrusions (212) other than the release sleeve (216). Holmqvist cannot be modified to have an intermediary release member as claimed without it significantly altering the internal mechanism of the device.
Holmqvist discloses the device of claims 1-3 and 7, as discussed above. Regarding claim 8, Holmqvist discloses a needle cover spring (139 in Fig. 11-12), but the needle cover spring (139) does not act on said release sleeve (216) not even indirectly. Holmqvist instead discloses after delivery and the device is removed from the injection site, the spring (139) urges the cover (136) to be locked into its extended position, but the other structures remain where they are as the device is intended to be discarded after single use. There is no motivation to have the release sleeve be urged to a more forward position as the device is not intended to be reused, and Holmqvist cannot be modified to have a spring that acts on the release sleeve (216) to urge it forward as this would significantly alter the internal mechanism of the plunger rod of the device.
Andre discloses a medicament delivery device (see Fig. 1) comprising a body (10), a medicament container (86), a plunger rod (112 in Fig. 9), a drive spring (114 in Fig. 9), an activator comprised of a needle cover (54 in Fig. 1), trigger (180 in Fig. 9), and release sleeve (160 in Fig. 9). Wherein the release sleeve (160) comprises a safety mechanism in the form of a guide-track comprising cut-outs (168 in Fig. 12b) and support surfaces (170 in Fig.12b). While the support surfaces (170 in Fig. 12b) contact the protrusions (172) of the plunger rod (112) to prevent inadvertent activation, the support surfaces (170) of the guide-track of the release sleeve (160) do not meet the interpretation of the safety mechanism under 112(f) which is interpreted as a safety pin or equivalent elongated structure. However, examiner notes, the medicament delivery device of Andre functions in a similar manner with the needle cover (54) moving proximal when the device is pressed to the injection site, which causes a chain reaction with the trigger (180) and release sleeve (160) such that the protrusions (172) of the plunger rod (112) are pushed out of contact with the support surfaces (170) of the release sleeve (160) and into grooves (166) which allows the plunger rod (112) to be urged distally by the force of the spring (114, see para. 0045-0047). Thus, Andre does not disclose the limitations of claim 1 and cannot be modified to have the safety mechanism as interpreted under 112(f) without altering the internal mechanism of Andre significantly and thus rendering it inoperable for its intended operation.
Therefore, there is no reference that teaches or discloses the limitations of claims 6 and 8, and thus does not disclose the limitations of claims 9-14 dependent upon claim 8.
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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.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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