DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/25/23 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 05/25/23 has been entered. Claims 1-15 are cancelled. Claims 16-35 are newly presented. Therefore, claims 16-35 are pending in the application.
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“a helical portion extending in a direction parallel to the longitudinal axis” such as in at least claim 19-- Applicant disclosure shows only a longitudinal path in a direction parallel to the longitudinal axis (see FIGs. 1&2).
“user-visible surface is a part of an external surface of the enclosing portion of the housing” such as in at least claim 25—Applicant only shows the user-visible surface on the cap (see FIGs. 1&2).
“cap comprises a distal portion enclosed by the enclosing portion of the housing” such as in at least claim 25—Applicant does not show a distal portion of the cap enclosed by any structure of the housing
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There does not appear to be support for axial movement in the circumferential portions as recited in claim 33 (see 112b rejection below).
Claim Objections
Applicant is advised that should claim 16 be found allowable, claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 23 and 33 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 23 recites the limitation "the second circumferential portion" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Clam 23 depends from claim 22 which introduces a “bump” for antecedent basis for “the bump” recited in claim 23. Claim 22 subsequently depends from claim 20 which only recites a “second longitudinal portion” of the labyrinth. “A second circumferential portion” is first introduced in claim 21. Therefore, for purposes of examination, the examiner interprets that claim 22 depends from claim 21 instead of claim 20 in order to provide antecedent basis for "the second circumferential portion" in claim 23.
Regarding claim 33, lines recite “wherein the protrusion is axially movable relative to the user-visible surface during movement within the circumferential portions and the longitudinal portion.” However, in view of Applicant disclosure, it is unclear to the examiner how the protrusion is axially movable within the circumferential portions when the protrusion may only rotate in the circumferential portions (See Applicant disclosure Fig. 4A-D and [0075]: circumferential portions only allow circumferential movement). The lack of clarity borders on a 112a issue because it does not appear that Applicant has support for any axial movement in the circumferential portions (see Applicant disclosure [0016] & [0022]: disclosing axial movement only in the longitudinal portions and specification objection above). For purposes of examination, the examiner interprets that any circumferential portion disclosed by the prior art would function as claimed by Applicant.
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 16-18, 20, 26-27, 29, and 31-34 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. 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 one of the cap and 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 other one of the cap (21) and the housing 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).
Regarding claim 17, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 16, and Wendland 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, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 17, and Wendland 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, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 18, and Wendland 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 26, Wendland 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, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 26, and Wendland 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, Wendland discloses the medicament delivery device of claim 26, and Wendland further discloses wherein the medicament delivery device (30, see FIG. 4) is an auto-injector (see [0076]: device 30 is an autoinjector).
Regarding claim 31, Wendland discloses a sub-assembly for a medicament delivery device, the sub- assembly (see FIG.4 and [0111-0112]: FIG. 10 is similar to embodiment of Figs.4-7c with different bayonet connection. Thus, FIG. 4 is referenced for similar structures of FIG. 10A) 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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and
a cap (21) releasably attached to (see [0113-0123]: cap removal by protrusion 62A following labyrinth path) the proximal end (see cap 21 attached to proximal end of housing in FIG. 4) of the housing (11);
wherein one of the cap and the housing (11) comprises a user-visible surface (surface comprising 33, user-visible shown in FIG. 6. Surface in FIG. 10A is similar numeral 63) extending in a circumferential direction (by track portions 63D and 63B as seen in FIG. 10A) relative to the axis (A), the surface (surface comprising 63) comprising a cut-out (63, see FIG. 10A and [0113]: 63 is a cutout to receive the protrusion);
wherein the other one of the cap (21) and the housing comprises a protrusion (62A) in the cut-out (as seen in FIG. 10A and described in [0113] and [0081] &[0084] of similar structures for FIG. 4-7C), and
wherein the cut-out (63, see FIG. 10A) defines a user-visible labyrinth (paths 63D, 63C, 63B, 63A) which the protrusion (62A) must follow during use in order for the cap (21) to be detached from (see [0113-0123]: cap removal by protrusion 62A following labyrinth path) the housing (11).
Regarding claim 32, Wendland (FIG. 10A) discloses the sub-assembly of claim 32, and Wendland further discloses wherein the labyrinth (paths 63D, 63C, 63B, 63A, see FIG. 10A and [0114]) comprises two circumferential portions (63D and 63B) and a longitudinal portion (63C).
Regarding claim 33, Wendland (FIG. 10A) discloses the sub-assembly of claim 32, and Wendland further discloses wherein the protrusion (62A, see FIG. 10A) is axially movable (see [0119-0120]) relative to the user-visible surface (surface of 11 with track 63) during movement within the circumferential portions (see 112b rejection above. Wendland FIG.10A has circumferential portions and therefore meets the limitation) and the longitudinal portion (63C, see [0119-0120]).
Regarding claim 34, Wendland (FIG. 10A) discloses the sub-assembly of claim 32, and Wendland further discloses wherein the sub-assembly comprises a bump (64, see FIG. 10A) extending from an edge (bottom edge of 63, see ‘Modified FIG. 10Ai’ below)
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of the cut-out (63) of the user-visible surface (surface comprising 63) into the labyrinth (paths 63D, 63C, 63B, and 63A), where the bump (64) extends into (see [0115]) one of the circumferential portions (63D) of the labyrinth (paths 63D, 63C, 63B, and 63A).
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 19, 21-25, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Wendland (U.S. PGPUB No. 2019/0001070).
Regarding claim 19, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 16, and Wendland (FIGs. 4-7C) further discloses Wendland further discloses wherein the labyrinth (paths 33A/B/C, see FIG. 7A) comprises a first longitudinal portion (33C), a circumferential portion (33B), and a second longitudinal portion (33A).
Wendland (FIGs. 4-7C) is silent to “wherein the labyrinth comprises a helical portion extending in a direction parallel to the longitudinal axis and in a direction around the longitudinal axis between a first end and a second end; and wherein the protrusion is movable relative to the user-visible surface between the first end of the helical portion and the second end of the helical portion.”
However, in another embodiment (see FIG. 9A and [0102]), Wendland teaches a user-visible surface (surface comprising 53) comprising a cut-out (53, see [0104]) defining a labyrinth (53B & 53A) which a protrusion (52A) follows in order for a cap to be detached (see [0102-0109]) from a housing (11), wherein the labyrinth (53B & 53A) comprises a helical portion (53A including sloping surface forming portion of a spiral) extending in a direction parallel to the longitudinal axis (parallely extending portion of 53A, see filled-in rectangle in ‘Modified FIG. 9A’ below)
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and in a direction around the longitudinal axis (see sloping portion of 53A) between a first end (see ‘Modified FIG. 9A’ above) and a second end (see ‘Modified FIG. 9A’ above); and wherein a protrusion (52A) is movable relative to (see [0107-0109]) the user-visible surface (surface comprising 53) between the first end of the helical portion (see ‘Modified FIG. 9A’ above) and the second end of the helical portion (see ‘Modified FIG. 9A’ above).
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 substitute the second longitudinal portion of the labyrinth disclosed in Wendland (FIGs. 4-7C) with the helical portion of the labyrinth as taught by Wendland (see FIG. 9A) for the purpose of removing the cap at a slower rate to achieve a more controlled removal of the cap from the housing (see [0109]), thus achieving “wherein the labyrinth comprises a helical portion extending in a direction parallel to the longitudinal axis and in a direction around the longitudinal axis between a first end and a second end; and wherein the protrusion is movable relative to the user-visible surface between the first end of the helical portion and the second end of the helical portion.”
Regarding claim 21, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 20, but Wendland (FIGs. 4-7C) is 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 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, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim [[20]] 21, but Wendland (FIGs. 4-7C) 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, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 22, but Wendland (FIGs. 4-7C) is 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, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 16, and Wendland 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 25, Wendland discloses the sub-assembly for a medicament delivery device as claimed in claim 16, and Wendland further discloses wherein the housing (11, see FIG. 4) comprises an enclosing portion (leftward of structure 11B, see ‘Modified FIG. 5’ below and see enclosing portion housing distal portion 24 of cap in FIG. 4) on the proximal end of the housing (11);
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wherein the cap (21) comprises a distal portion (24) enclosed by (as seen in FIG. 4) the enclosing portion (leftward of structure 11B or see ‘Modified FIG. 5’ above) of the housing (11) when the cap (21) is attached on (as in FIG. 4) the proximal end (see ‘Modified FIG. 5’ above) of the housing (11); and wherein the user- visible surface (surface comprising track 33, see FIG.6) is a part of an external surface (see FIG. 6 or ‘Modified FIG. 5’ above for clarity) of the enclosing portion (leftward of structure 11B or see ‘Modified FIG. 5’ above) of the housing (11), and the protrusion (32A) is inwardly protruding toward (see FIG. 6 and [0077]) the distal portion (24) of the cap (21) relative to the longitudinal axis (“A” as seen in FIG. 4 or 5)
Wendland (FIGs. 4-7C) is silent to the protrusion “is outwardly protruding away” from the distal portion of the cap.
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 protrusion (88) is outwardly protruding away from (see [0142]) a distal portion (portion of cap comprising tracks 89A/B) of the cap (81).
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 coupling mechanism disclosed in Wendland (FIGs. 4-7C) with an outwardly extending protrusion of the coupling mechanism 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 engaging a track in Wendland FIGs. 4-7C) for another known element (an outward extending protrusion engaging a track 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 the protrusion “is outwardly protruding away” from the distal portion of the cap.
Regarding claim 30, Wendland 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.
Regarding claim 35, Wendland (FIG. 10A) discloses the sub-assembly of claim 31 , and Wendland further discloses wherein the cap (21, see FIG. 4) comprises an enclosing body (23, see [0065]) and the housing (11) comprises a proximal portion (needle shield 22) arranged within an 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 31 above) of the housing (11), where the user-visible surface (surface comprising 63, see FIG. 10A) is a part of an external surface (such as shown in FIG. 6).
Wendland (FIG. 10A) is silent to wherein the user-visible surface is a part of an external surface “of the enclosing body of the cap and where the protrusion radially protrudes from an outer surface of the proximal portion of the housing.”
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 where a protrusion (88) radially protrudes from (see [0142]) from an outer surface (see surface where 88 is disposed in ‘Modified FIG. 12’ above) of a proximal portion (rightward end of housing 11) of 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 inwardly extending protrusion of the cap that engages a user-visible surface with a track formed in the housing disclosed in Wendland (FIG. 10A) 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 FIG. 10A) 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 where the protrusion radially protrudes from an outer surface of the proximal portion of the housing.”
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, Wendland discloses the medicament delivery device according to claim 27, but 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.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783