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
The amendment filed 05/26/26 has been entered. Claims 16, 18, and 22-23 have been amended. Claims 17, 20-21, 24, and 26-30 are in the original/ previously presented form. Claims 1-15, 19, 25, and 31-35 are cancelled. Thus, claims 16-18, 20-24, and 26-30 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 03/20/26.
Acknowledgements
In the current Application, Applicant identifies distal as the direction pointing away from the dose delivery site and proximal as the direction pointing toward the delivery site (see [0010] and at least claim 16). Therefore, the examiner will apply the same directional interpretation to the prior art.
Claim Objections
Claims 22 and 23 are objected to because of the following informalities:
Claim 22 lines 1-2 read “The sub-assembly for a medicament delivery device as claimed claim in 20” and should likely read “The sub-assembly for a medicament delivery device as claimed [[claim]] in claim 20” for grammatical reasons
Claim 23 lines 2-3 read “wherein the bump extends in the direction of the longitudinal axis into the second circumferential portion of the labyrinth” and should likely read “wherein [[the]] a bump extends in the direction of the longitudinal axis into the second circumferential portion of the labyrinth” in order to provide antecedent basis for “bump” in claim 23. Claim 23 depends from claim 21 which provides proper antecedent basis for “the second circumferential portion” in claim 23. However, “a bump” is not introduced in claim 21 and therefore there is currently no antecedent basis for “bump”. Alternatively, Applicant could change the claim dependency such that claim 23 depends from claim 22 and claim 22 depends from claim 21 to provide proper antecedent basis for bump without having to modify the claim language.
Appropriate correction is required.
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 16, 26, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wendland et al. (U.S. PGPUB No. 2019/0001070), hereinafter Wendland.
Regarding claim 16, Wendland discloses a sub-assembly for a medicament delivery device, the sub-assembly (see FIG. 12 and [0134-0136]) comprising:
a housing (11) extending along a longitudinal axis from a proximal end (19, best seen in FIG. 15 after separation from cap and see [0137]) to a distal end (leftward-most end of housing 11/ toward user);
a cap (81) releasably attached (see [0136]: cap removably attached to proximal end 19) to the proximal end (19) of the housing (11);
wherein the cap (81) comprises a user-visible surface (surface of 81 comprising latch 87 formed of tracks 89A & 89B) extending in a circumferential direction (track 89B, see ‘Modified FIG. 12’ below and [0142]) relative to the axis,
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the surface (surface of 81 comprising latch 87 formed of tracks 89A & 89B) comprising a cut-out (latch 87 formed of tracks/cutouts 89A & 89B);
wherein the housing (11) comprises a protrusion (88, see [0142]: pins 88 project radially outward from body 11) in the cut-out (latch 87 formed of tracks/cutouts 89A & 89B); and
wherein the cut-out (latch 87 formed of tracks/cutouts 89A & 89B) defines a user-visible labyrinth (labyrinth path formed by tracks 89A&89B is user-visible as shown in FIG. 12) which the protrusion (88) must follow during use in order for the cap (81) to be detached from (see [0142-0147]) the housing (11).
Regarding claim 26, Wendland discloses a medicament delivery device (80, see FIG.12 and [0134]) comprising a sub-assembly according to claim 16 (see rejection of claim 16 above).
Regarding claim 29, Wendland discloses the medicament delivery device of claim 26, and Wendland further discloses wherein the medicament delivery device (80, see FIG. 12) is an auto-injector (see [0134]: device 80 is an autoinjector).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16-18, 20-24, 26-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wendland (U.S. PGPUB No. 2019/0001070).
Regarding claim 16, Wendland discloses a sub-assembly for a medicament delivery device, the sub-assembly (see FIG. 4 and [0076]) comprising:
a housing (11) extending along a longitudinal axis (“A” in Fig. 4) from a proximal end (see ‘Modified FIG. 4’ below) to a distal end (see ‘Modified FIG. 4’ below);
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a cap (21) releasably attached to (see [0085-0088]: cap removal by protrusion 32A following labyrinth path) the proximal end (see cap 21 attached to proximal end of housing in FIG. 4) of the housing (11);
wherein the housing (11) comprises a user-visible surface (surface comprising 33, user-visible shown in FIG. 6) extending in a circumferential direction (by track portion 33B as seen in FIG. 7A) relative to the axis (A), the surface (surface comprising 33) comprising a cut-out (33, see FIG. 6 and [0078]: 33 is a cutout);
wherein the cap (21) comprises a protrusion (32A) in the cut-out (cutout of 33, see FIG. 4, FIG. 7A, and [0081] & [0084]); and
wherein the cut-out (cutout of 33) defines a user-visible labyrinth (paths 33A,B,C) which the protrusion (32A) must follow during use in order for the cap (21) to be detached (see [0080-0088]: cap removal process achieved by protrusion 32A following paths 33A/B/C) from the housing (11).
Wendland (FIG. 4-7C) discloses the housing comprises the user visible surface and the cap comprises the protrusion. Therefore, Wendland (FIG. 4-7C) is silent to “the cap” comprises a user-visible surface and “the housing” comprises a protrusion.
However, in an alternate embodiment (see FIG. 12), Wendland teaches a sub-assembly for a medicament delivery device, the sub-assembly (see FIG. 12 and [0134-0136]) comprising:
a housing (11) extending along a longitudinal axis from a proximal end (19, best seen in FIG. 15 after separation from cap and see [0137]) to a distal end (leftward-most end of housing 11/ toward user);
a cap (81) releasably attached (see [0136]: cap removably attached to proximal end 19) to the proximal end (19) of the housing (11);
wherein the cap (81) comprises a user-visible surface (surface of 81 comprising latch 87 formed of tracks 89A & 89B) extending in a circumferential direction (track 89B, see ‘Modified FIG. 12’ below and [0142]) relative to the axis,
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the surface (surface of 81 comprising latch 87 formed of tracks 89A & 89B) comprising a cut-out (latch 87 formed of tracks/cutouts 89A & 89B);
wherein the housing (11) comprises a protrusion (88, see [0142]: pins 88 project radially outward from body 11) in the cut-out (latch 87 formed of tracks/cutouts 89A & 89B); and
wherein the cut-out (latch 87 formed of tracks/cutouts 89A & 89B) defines a user-visible labyrinth (labyrinth path formed by tracks 89A&89B is user-visible as shown in FIG. 12) which the protrusion (88) must follow during use in order for the cap (81) to be detached from (see [0142-0147]) the housing (11).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the user visible surface formed in the housing and the protrusion formed on the cap disclosed in Wendland (Figs. 4-7C) to be a user-visible surface formed in the cap and a protrusion formed on the housing, respectively, as taught by Wendland FIG. 12.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a user visible surface with a track formed on a housing and removably coupled to a protrusion formed on a cap, as in Wendland FIG. 4-7C) for another known element (a user visible surface with a track formed on a cap and removably coupled to a protrusion formed on a housing, as in Wendland FIG. 12) in the art to obtain the predictable result of removably coupling two concentrically disposed telescoping structures together by way of a protrusion and track, (see MPEP § 2143.I.B), thus achieving “the cap” comprises a user-visible surface and “the housing” comprises a protrusion.
Regarding claim 17, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 16, and Wendland (FIGs.4-7C) further discloses wherein the labyrinth (paths 33A/B/C, see FIG. 7A) comprises a first longitudinal portion (33C) extending along the longitudinal axis (see ‘Modified FIG. 6’ below and [0079])
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between a first end (see ‘Modified FIG. 7A’ below) and a second end (see ‘Modified FIG. 7A’ below); and
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wherein the protrusion (32A) is axially movable relative to (see [0082]) the user-visible surface (33) between the first end (see ‘Modified FIG. 7A’ above) of the first longitudinal portion (33C) and the second end (see ‘Modified FIG. 7A’ above) of the first longitudinal portion (33C).
Regarding claim 18, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 17, and Wendland (FIGs.4-7C) further discloses wherein the labyrinth (paths 33A/B/C, see FIG. 7A) comprises a first circumferential portion (33B) extending around the longitudinal axis (see ‘Modified FIG. 6’ in claim 17 rejection above) between a first end (see ‘Modified FIG. 7Ai’ below) and a second end (see ‘Modified FIG. 7Ai’ below);
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and wherein the protrusion (32A) is circumferentially movable relative to (see [0082-0083]) the user-visible surface (surface comprising 33) between the first end of the first circumferential portion (see ‘Modified FIG. 7A’ above) and the second end of the first circumferential portion (see ‘Modified FIG. 7A’ above).
Regarding claim 20, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 18, and Wendland (FIGs.4-7C) further discloses wherein the labyrinth (paths 33A,B,C) comprises a second longitudinal portion (33A) extending along the longitudinal axis (see [0083]: cap is twisted and then axially movable within 33A, thus axial movement occurs while 33A extends along longitudinal axis, see ‘Modified FIG. 6’ above in the rejection of claim 17 above) between a first end (see ‘Modified FIG. 7Aii’ below) and a second end (see ‘Modified FIG. 7Aii’ below); and
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wherein the protrusion (32A) is axially movable relative to (see [0083]) the user-visible surface (surface comprising 33) between the first end of the second longitudinal portion (see ‘Modified FIG. 7Aii’ above) and the second end of the second longitudinal portion (see ‘Modified FIG. 7Aii’ above).
Regarding claim 21, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 20, but Wendland (FIGs. 4-7C in view of FIG. 12) remain silent to “wherein the labyrinth comprises a second circumferential portion extending around the longitudinal axis between a first end and a second end; and wherein the protrusion is circumferentially movable relative to the user-visible surface between the first end of the second circumferential portion and the second end of the second circumferential portion.”
However, in an alternate embodiment (See FIG. 10A and [0111-0112]), Wendland teaches a user-visible surface (surface comprising 63) comprising a cut-out (63, see [0113-0115]) defining a labyrinth (paths 63D, 63C, 63B, and 63A) which a protrusion (62A) follows in order for a cap to be detached (see [0111-0112] & [0122-0123]) from a housing (11), wherein the labyrinth (paths 63D, 63C, 63B, and 63A) comprises a second circumferential portion (63B) extending around the longitudinal axis (see [0121]: 63B circumferentially disposed and thus extends “around” the longitudinal axis) between a first end (see ‘Modified FIG. 10A’ below) and a second end (see ‘Modified FIG. 10A’ below); and
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wherein the protrusion (62A) is circumferentially movable relative to the user-visible surface (surface comprising 63) between the first end (see ‘Modified FIG. 10A’ above) of the second circumferential portion (63B) and the second end (see ‘Modified FIG. 10A’ above) of the second circumferential portion (63B).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the labyrinth path with the first circumferential portion disclosed in Wendland (FIGs. 4-7C) to include a second circumferential portion as taught by Wendland (FIG. 10A) for the purpose of requiring the cap to be rotated in stages to allow for a more controlled removal of the cap from the housing (see [0123]), thus achieving “wherein the labyrinth comprises a second circumferential portion extending around the longitudinal axis between a first end and a second end; and wherein the protrusion is circumferentially movable relative to the user-visible surface between the first end of the second circumferential portion and the second end of the second circumferential portion.”
Regarding claim 22, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed claim in 20, but Modified Wendland (FIGs. 4-7C in view of FIG. 12) is silent to “wherein the sub-assembly comprises a bump extending from an edge of the cut-out of the user-visible surface into the labyrinth.”
However, in an alternate embodiment (See FIG. 10A and [0111-0112]), Wendland teaches a sub-assembly for a medicament delivery device (see [0102]) with a user-visible surface (surface comprising 63) comprising a cut-out (63, see [0113-0115]) defining a labyrinth (paths 63D, 63C, 63B, and 63A) which a protrusion (62A) follows in order for a cap to be detached (see [0111-0112] & [0122-0123]) from a housing (11), wherein the sub-assembly comprises a bump (64) extending from an edge (bottom edge of 63, see ‘Modified FIG. 10Ai’ below)
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of a cut-out (63) of the user-visible surface (surface comprising 63) into (see [0115]: projection 64 projects into track 63D) a labyrinth (path of 63D of paths 63D, 63C, 63B, and 63A).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the labyrinth disclosed in Wendland (FIGs. 4-7C) to include a bump extending from an edge of the cut-out and into the labyrinth as taught by Wendland (FIG. 10A) for the purpose of forming a surface in the labyrinth that resists rotational movement and prevents the cap from being accidentally removed (see [0118]), thus achieving “wherein the sub-assembly comprises a bump extending from an edge of the cut-out of the user-visible surface into the labyrinth.”
Regarding claim 23, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 21, but Modified Wendland (FIGs. 4-7C in view of FIG. 12) remains silent to “wherein the bump extends in the direction of the longitudinal axis into the second circumferential portion of the labyrinth.”
However, in an alternate embodiment (See FIG. 10A and [0111-0112]), Wendland teaches a sub-assembly for a medicament delivery device (see [0102]) with a user-visible surface (surface comprising 63) comprising a cut-out (63, see [0113-0115]) defining a labyrinth (paths 63D, 63C, 63B, and 63A) with a first circumferential portion (63D, see [0114]) and a second circumferential portion (63B, see [0114]), wherein the sub-assembly comprises a bump (64), and wherein the bump (64) extends in the direction of the longitudinal axis (see [0115]) into the first circumferential portion (63D) of the labyrinth (paths 63D, 63C, 63B, and 63A).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the labyrinth with the first circumferential portion disclosed in Wendland (FIGs. 4-7C) to include a second circumferential portion as taught by Wendland (FIG. 10A) for the purpose of requiring the cap to be rotated in stages to allow for a more controlled removal of the cap from the housing (see [0123]), thus achieving “the second circumferential portion of the labyrinth.”
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second circumferential portion taught by Wendland (FIGs. 4-7C in view of FIG. 10A) to include a bump extending in the longitudinal direction as taught by Wendland (FIG.10A) for the purpose of providing a projection such that rotational movement is resisted and accidental removal is prevented in each circumferential track (see [0118-0119]), thus achieving “wherein the bump extends in the direction of the longitudinal axis into the second circumferential portion of the labyrinth.” Further, mere duplication of parts (i.e.: duplicating the first bump 64 disposed in the first circumferential track 63D to form a second bump in a second circumferential track) has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04.VI.B).
Regarding claim 24, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 16, and Wendland (FIGs. 4-7C) further discloses wherein the cap (21, see FIG. 4) comprises an enclosing body (23, see [0065]) defining an interior area (area housing needle shield 22, see [0065]); wherein the housing (11) comprises a proximal portion (needle shield 22) arranged within the interior area (area housing needle shield 22) of the enclosing body (23) when the cap (21) is attached to (as in FIG.4) the proximal end (see ‘Modified FIG. 4’ in the rejection of claim 16 above) of the housing (11); and wherein the user-visible surface (surface comprising 33) is a part of an external surface (see FIG.6).
Wendland (FIGs. 4-7C) is silent to wherein the user-visible surface is a part of an external surface “of the enclosing body of the cap; and wherein the protrusion is protruding away from the proximal portion of the housing relative to the longitudinal axis.”
However, in an alternate embodiment (see FIG. 12), Wendland teaches a sub-assembly for a medicament delivery device, the sub-assembly comprising a housing (11) and a cap (81) removably attached to the housing (see [0136]); wherein a user-visible surface (surface of 81 comprising latch 87 formed of tracks 89A & 89B) is a part of an external surface (see ‘Modified FIG. 12’ below)
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of an enclosing body (85, seen in FIG. 13) of the cap (81); and wherein a protrusion (88) is protruding away (see [0142]) from a proximal portion (rightward end of housing 11) of the housing (11) relative to a longitudinal axis (horizontal axis through housing 11 in FIG.12).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the inwardly extending protrusion of the cap that engages a user-visible surface with a track formed in the housing disclosed in Wendland (FIGs. 4-7C) with an outwardly extending protrusion of the housing that engages a user-visible surface with a track formed in the cap as taught by Wendland (FIG.12).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (an inwardly extending protrusion of an outer element engaging a track of an inward structure, like the housing in Wendland FIGs. 4-7C) for another known element (an outward extending protrusion of an inner element engaging a track of an outward structure—like the cap in Wendland FIG.12) in the art to obtain the predictable result of coupling two circumferentially disposed telescoping structures together by way of a protrusion and track, (see MPEP § 2143.I.B), thus achieving wherein the user-visible surface is a part of an external surface “of the enclosing body of the cap; and wherein the protrusion is protruding away from the proximal portion of the housing relative to the longitudinal axis.”
Regarding claim 26, Wendland (FIGs. 4-7C) discloses a medicament delivery device (30, see FIG.4 and [0076]) comprising a sub-assembly according to claim 16 (see rejection of claim 16 above).
Regarding claim 27, the modified system of Wendland teaches the sub-assembly for a medicament delivery device as claimed in claim 26, and Wendland (FIGs.4-7C) further discloses comprising a needle assembly (22 & 17, see FIG.4 and [0084]); wherein the needle assembly (22 & 17) comprises a needle (17) and a needle cap (22) at least partially enclosing (see FIG. 4 and [0084]) the needle (17); and wherein the needle cap (22) is attached to (see [0084]) the cap (21).
Regarding claim 29, the modified system of Wendland teaches the medicament delivery device of claim 26, and Wendland (FIGs. 4-7C) further discloses wherein the medicament delivery device (30, see FIG. 4) is an auto-injector (see [0076]: device 30 is an autoinjector).
Regarding claim 30, Wendland (FIGs. 4-7C) discloses a method of operating a medicament delivery device according to claim 26 (see rejection of claim 26 above), the method comprising the following steps with the following order:
pushing the cap (21 comprises protrusion 32A, see FIG. 7A) relative to the housing (11) towards the distal direction (see [0082]: cap urged toward body of housing via track portion 33C) of the housing (11) in the direction of the longitudinal axis (A, see FIG. 4 and [0082]);
rotating (see [0083]: cap twisted through track portion 33B) the cap (21 comprises protrusion 32A, see FIG. 7B with protrusion location after pushing pushed distally) relative to the housing (11) around the longitudinal axis (A, see FIG. 4);
pulling (in direction of force arrow F in FIG. 4, see [0084-0086]) the enclosing body (23) of the cap (21) relative to the housing (11) towards the proximal direction (leftward in FIG. 4) of the housing (11) in the direction of the longitudinal axis (A in FIG. 4).
Wendland (Figs. 4-7C) is silent to first “rotating the cap relative to the housing around the longitudinal axis;” before the other recited steps.
However, in an alternate embodiment (see FIG. 10A), Wendland discloses a method of operating a medicament delivery device with a first step of rotating (see [0119]: cap is twisted) a cap (cap comprising protrusion 62A as seen in FIG. 10A and described in [0112]) relative to the housing (11) around the longitudinal axis (A as shown in FIG. 4).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of operating a medicament delivery device disclosed in Wendland (FIG. 4-7C) to include a first step of rotating the cap about the longitudinal axis as taught by Wendland (FIG. 10A—such as by providing the track of FIG. 7A with a first path extending in the circumferential direction, similar to track portion 63D taught in Wendland FIG.10A) for the purpose of requiring the cap to be rotated in stages to allow for a more controlled removal of the cap from the housing (see [0123]), thus achieving first “rotating the cap relative to the housing around the longitudinal axis;” before the other recited steps.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wendland as applied to claim 27 above, and further in view of Suzuki et al. (U.S. PGPUB No. 2014/0135707), hereinafter Suzuki.
Regarding claim 28, the modified system of Wendland teaches the medicament delivery device according to claim 27, but Modified Wendland is silent to “comprising a needle holder attached to the needle and a connector; wherein the needle cap comprises a rib partially situated within a cut-out of the needle holder and partially engaged with a proximally directed surface of the needle holder; wherein the connector comprises a slot; and wherein the needle holder comprises a rib.”
However, Suzuki teaches a medicament delivery device comprising a needle assembly (see FIG. 4 and [0005]); wherein the needle assembly comprises a needle (100A, see [0046]) and a needle cap (11) at least partially enclosing (as seen in FIG. 5 and see [0050-0051]: needle only projects through hole 118 when actuated) the needle (100A); and comprising a needle holder (10) attached to the needle (100A, see [0046]) and a connector (12, see [0048]); wherein the needle cap (11) comprises a rib (pillars 111 with projections 111T, see [0052]) partially situated within (see [0055]) a cut-out (10N) of the needle holder (10) and partially engaged with (see [0065]) a proximally directed surface (proximal face of 10P, see ‘Modified FIG. 4’ below)
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of the needle holder (10); wherein the connector (12) comprises a slot (121A, see [0055]); and wherein the needle holder (10) comprises a rib (10R).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle assembly disclosed in Wendland to further comprise a needle holder attached to the needle and a connector; wherein the needle cap comprises a rib partially situated within a cut-out of the needle holder and partially engaged with a proximally directed surface of the needle holder; wherein the connector comprises a slot; and wherein the needle holder comprises a rib as taught by Suzuki for the purpose of forming a substantially complete circular ring protecting the needle while setting axial advancement and retraction of the needle (see [0055]), thus achieving “comprising a needle holder attached to the needle and a connector; wherein the needle cap comprises a rib partially situated within a cut-out of the needle holder and partially engaged with a proximally directed surface of the needle holder; wherein the connector comprises a slot; and wherein the needle holder comprises a rib.”
Response to Arguments
Applicant’s arguments with respect to claim 16 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.
Applicant argues against the 35 U.S.C. § 102 claim rejection using Wendland (FIGs. 4-7C). However, a new 35 U.S.C. § 102 claim rejection using Wendland (FIG. 12) has instead been presented in view of the amended claim 16. Thus, the arguments against the previous 35 U.S.C. § 102 claim rejection as presented on pages 8-9 of Applicant remarks are moot.
Applicant does not appear to argue any of the 35 U.S.C. § 103 combinations previously applied in the non-final rejection mailed 03/20/26 (see page 9 of Applicant remarks). Therefore, the examiner has maintained the 35 U.S.C. § 103 claim rejections using a combination of embodiments of Wendland and/or a combination of Wendland in view of Suzuki.
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 KATHLEEN PAIGE VOKES 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.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights