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 Preliminary Amendment and Acknowledgements
The preliminary amendment filed 05/25/23 has been entered. Claims 1-16 are cancelled. Claims 17-36 are newly presented. Thus, claims 17-36 remain pending in the application.
Applicant has defined a proximal end as the end of the device closest to the delivery site and the distal end as the end of the device closest to the gripping portion (see at least [0004] of Applicant disclosure). Therefore, the proximal and distal end interpretations of the prior art will be applied in accordance with Applicant definition.
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 “first surface” of the flexible arm as recited in at least claims 17 and 33 does not appear to be shown. [0042] of Applicant disclosure describes the surface but there is no numeral provided in the specification or on the drawings. Applicant could remedy this objection by including a numeral in [0042] and in the drawings for identifying the structure of “a first surface” of the flexible arm
A “second surface” of the flexible arm “facing in a radial direction relative to the axis” as in at least claims 17 and 33 is not shown. In [0052] of Applicant disclosure, a second surface 28 of the housing is described, but the “a second surface” of the housing seems to be a separate structure than a second surface of the flexible arm.
a “surface” of the distal shield facing in the radial direction is not shown. [0041] discloses a surface of the flexible arms and [0062] describes a surface of the proximal shield, but the examiner could not locate a description or numeral on the drawings for the “a surface” in the radial direction of the distal shield
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:
A second surface of the flexible arm does not appear to be described in the specification and is recited in at least claims 17 and 33 (see drawing objection above and 112b rejection below)
A surface of the distal shield does not appear to be described in the specification and is recited in at least claims 17 and 33 (see drawing objection above and 112b rejection below)
Claim Objections
Claim 36 is objected to because of the following informalities:
Claim 36 line 2 reads “wherein seal comprises a septum and the distal end of the distal shield comprises a septum.” And should likely read “wherein the seal of the proximal shield comprises a septum and the distal end of the distal shield comprises a septum.” To provide antecedent basis for “seal” and to ensure that the claim language is clearly reciting two separate septum structures of each shield portion
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-36 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.
Regarding claim 17, lines 4-6 read “a housing comprising a body and a flexible arm, the flexible arm extending in the longitudinal direction from a proximal end moveable relative to the body to a distal end attached to the body”. In view of Applicant disclosure, it is unclear to the examiner how the flexible arm is “moveable relative to the body to a distal end attached to the body” when it appears that the flexible arm (24, see Fig. 5 and [0042]) is affixed to the body (22). Therefore, the flexible arm cannot be “moveable relative to the body to a distal end” such that the flexible arm is moving in a longitudinal direction relative to the body (i.e.: to a distal end). In [0042], Applicant describes that the flexible arm can move relative to the body in a radial direction. Therefore for purposes of examination, the examiner interprets claim 17 lines 4-6 to read “a housing comprising a body and a flexible arm, the flexible arm extending in the longitudinal direction from a proximal end [[moveable relative to the body]] to a distal end, the flexible arm attached to the body and moveable relative to the body” in order to best align with applicant disclosure for the structure.
Due to claim dependency from claim 17, claims 18-32 are subsequently rejected under 112b unless otherwise specifically noted in this section below.
Next, in regard to claim 17, Claim 17 recites the limitation "the first surface of the housing" in line 12. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the examiner if “the first surface” is intended to refer to the originally recited “first surface” of the flexible arm or if “the first surface of the housing” is supposed to be a different “first surface”. According to Applicant disclosure, a first surface 26 of the housing is described in [0041] and shown in Fig. 4. It appears that this “first surface” 26 is on the flexible arm. Therefore, for purposes of examination, the examiner interprets claim 17 line 12 to read “the first surface of the [[housing]] flexible arm". Applicant should amend the specification to indicate the surface 26 as on the arm if that is Applicant’s intent to ensure that the specification and claim language align.
Next, in regard to claim 17, Claim 17 recites the limitation "the second surface of the housing" in line 15. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the examiner if “the second surface” is intended to refer to the originally recited “first surface” of the flexible arm or if “the second surface of the housing” is supposed to be a different “second surface”. According to Applicant disclosure, a second surface 28 of the housing is described in [0052] and shown in Fig. 4. In view of this disclosure, it appears that this “second surface” 28 is on the flexible arm 24. Therefore, for purposes of examination, the examiner interprets claim 17 line 15 to read “the second surface of the [[housing]] flexible arm". Applicant should amend the specification to indicate the surface 28 as on the arm if that is Applicant’s intent to ensure that the specification and claim language align.
Next in regard to claim 17, lines 14-16 recite “the distal shield comprising a surface facing in the radial direction to interact with the second surface of the housing during use.” However, there is no description (see specification objection above) or depiction (see drawing objection above) in the drawings of the “a surface” of the distal shield. Therefore, it is unclear to the examiner how the “the distal shield comprising a surface facing in the radial direction” interacts with “the second surface”. Thus, for purposes of examination, the examiner interprets that any surface in the prior art “facing in the radial direction” of the distal shield would meet the claim language.
Regarding claim 18, lines 2-3 recite “wherein the medicament delivery member housing assembly comprises a needle attached to the housing.” In view of claim 17 from which claim 18 depends, this claim language appears to recite a secondary medicament delivery member in the form of a “needle” that is different than the originally recited “a medicament delivery member” as in claim 17. Thus, claim 18 appears to claim multiple medicament delivery members of the device. However, according to Applicant disclosure (see at least FIG. 4), it appears there is only one needle/ medicament delivery member of the device. Therefore, for purposes of examination, the examiner interprets claim 18 lines 2-3 to read “wherein the medicament delivery member [[housing assembly]] comprises a needle attached to the housing” to align with Applicant disclosure of the device having only one needle.
Regarding claim 30, lines recite “wherein the surface facing in the radial direction is configured to interact with the second surface of the housing during use…” Because there is no description (see specification objection above) or depiction (see drawing objection above) in the drawings of the “a surface” of the distal shield, it is unclear how the surface facing in the radial direction” interacts with “the second surface”. Thus, for purposes of examination, the examiner interprets that any surface in the prior art “facing in the radial direction” of the distal shield would meet the claim language.
Regarding claim 33, lines 4-6 recite “a flexible arm that extends in the longitudinal direction from a proximal end that is movable relative to the body to a distal end that is attached to the body”. However, similar to the recitation as recited in claim 17 (see 112b rejections above), in view of Applicant disclosure, it is unclear to the examiner how the flexible arm is movable in a longitudinal direction such that the arm is “is movable relative to the body to a distal end”. Again, for purposes of examination that align best with Applicant disclosure, the examiner interprets claim 33 lines 4-6 to read “a flexible arm that extends in the longitudinal direction from a proximal end [[that is movable relative to the body]] to a distal end, the flexible arm [[that]] is attached to the body and moveable relative to the body”.
Due to claim dependency from claim 33, claims 34-36 are subsequently rejected under 112b unless otherwise specifically noted in this section below.
Next, in regard to claim 33, Claim 33 recites the limitation "the first surface of the housing" in line 12. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the examiner if “the first surface” is intended to refer to the originally recited “first surface” of the flexible arm or if “the first surface of the housing” is supposed to be a different “first surface” (see similar 112b rejection in claim 17 above). According to Applicant disclosure, a first surface 26 of the housing is described in [0041] and shown in Fig. 4. It appears that this “first surface” 26 is on the flexible arm. Therefore, for purposes of examination, the examiner interprets claim 33 line 12 to read “the first surface of the [[housing]] flexible arm". Applicant should amend the specification to indicate the surface 26 as on the arm if that is Applicant’s intent to ensure that the specification and claim language align.
Next, in regard to claim 33, Claim 33 recites the limitation "the second surface of the housing" in line 15. There is insufficient antecedent basis for this limitation in the claim. It is unclear to the examiner if “the second surface” is intended to refer to the originally recited “first surface” of the flexible arm or if “the second surface of the housing” is supposed to be a different “second surface” (see similar 112b rejection to claim 17 above). According to Applicant disclosure, a second surface 28 of the housing is described in [0052] and shown in Fig. 4. In view of this disclosure, it appears that this “second surface” 28 is on the flexible arm 24. Therefore, for purposes of examination, the examiner interprets claim 33 line 15 to read “the second surface of the [[housing]] flexible arm". Applicant should amend the specification to indicate the surface 28 as on the arm if that is Applicant’s intent to ensure that the specification and claim language align.
Next in regard to claim 33, lines 14-16 recite “the distal shield comprising a surface facing in the radial direction to interact with the second surface of the housing during use.” However, there is no description (see specification objection above) or depiction (see drawing objection above) in the drawings of the “a surface” of the distal shield. Therefore, it is unclear to the examiner how the “the distal shield comprising a surface facing in the radial direction” interacts with “the second surface”. Thus, for purposes of examination, the examiner interprets that any surface in the prior art “facing in the radial direction” of the distal shield would meet the claim language.
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 17-21, 23, 28-30, and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schubert et al. (U.S. PGPUB No. 2010/0234811).
Regarding claim 17, Schubert discloses a medicament delivery member housing assembly (such as shown in Figs. 1 & 2A-B) extending along an axis in a longitudinal direction (see axis along longitudinal axis of the needle, “L” as seen in ‘Modified Fig. 2A’ below) from a proximal end (see rightward end in ‘Modified FIG. 2A’ below, closest to delivery site, aligning with Applicant disclosure [0004]) to a distal end (see leftward end in ‘Modified FIG. 2A’ below, away from delivery site, aligning with Applicant disclosure [0004]), the medicament delivery member housing assembly comprising:
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a housing (hub 1, see Fig. 1 and [0063]) comprising a body (see ‘Modified Fig. 2A’ above) and a flexible arm (3), the flexible arm (3) extending in the longitudinal direction from a proximal end (rightward end 5 of the arm 3, see Fig. 2A and [0063]) [[moveable relative to the body]] to a distal end (leftward end of the arm 3), the flexible arm (3) attached to the body (see center of needle hub surrounding needle shaft as in ‘Modified Fig. 2A’ above) and moveable relative to (as seen from Fig. 2A-2B and described in [0063] & [0065]) the body (see center of needle hub surrounding needle shaft as in ‘Modified Fig. 2A’ above), wherein the flexible arm (3) comprises a first surface (see ‘Modified FIG. 2A’ above) facing towards the proximal end (rightward) of the medicament delivery member housing assembly and a second surface (see ‘Modified FIG. 2A’ above) facing in a radial direction (second surface is facing radially outward relative to the longitudinal axis, “L”) relative to the axis (L);
a medicament delivery member (15 with tip 16, see [0060]);
a proximal shield (40) extending around a first end (tip 16) of the medicament delivery member (15), the proximal shield (40) comprising a surface (see ‘Modified Fig. 2A’ above) facing towards the distal end (leftwardly facing) of the medicament delivery member housing assembly to interact (see [0064]: protrusions 5 abut shield 40 and [0065]: abutment causes force on opposite end of hub at protrusions 6 to cause arms to deflect inwardly) with the first surface (see ‘Modified Fig. 2A’ above) of the [[housing]] flexible arm (3) during use (see [0064-0065]); and
a distal shield (30) extending around a distal end (end 17, see [0060]) of the medicament delivery member (15), the distal shield (30) being slidable in the longitudinal direction relative to (see Fig. 2A to 2B and [0064-0066]) the proximal shield (40), the distal shield (30) comprising a surface (see ‘Modified Fig. 2A’ above) facing in the radial direction (radially inward) to interact with (see 112b rejection above) the second surface (see ‘Modified Fig. 2A’ above) of the [[housing]] flexible arm (3) during use.
Regarding claim 18, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the medicament delivery member (15,see Fig. 2A) [[housing assembly]] comprises a needle (see [0060]) attached to (see [0057]) the housing (hub 1, see Fig. 1 and [0063]), and wherein the proximal end (rightward end in ‘Modified FIG. 2A’ above) of the medicament delivery member housing assembly is the end of the medicament delivery member housing assembly closest to the site of delivery of a medicament during use (see [0060]: needle tip 16 for penetrating delivery site. Tip 16 at rightward/proximal end).
Regarding claim 19, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the medicament delivery member housing assembly is configured to move from an initial extended position (see Fig. 2A) in which the medicament delivery member (15) is fully enclosed by the medicament delivery member housing assembly (see Fig. 2A) to a final compressed position (see FIG. 2B) where the medicament delivery member extends out of the proximal end (rightward end) of the proximal shield (40) and where the medicament delivery member (15) extends out of the distal end (leftward end) of the distal shield (30).
Regarding claim 20, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the medicament delivery member housing assembly is configured to move from the initial extended position (see Fig. 2A) to an intermediate partially-extended position (when the abutment between the protrusion 5 of the arms 3 and shield 40 is removed to allow the proximal shield to move in axial direction, see [0065]) and then to a final compressed position (see Fig. 2b)),
wherein in the initial extended position (see Fig. 2A), the first surface (see ‘Modified FIG. 2Ai’ below) of the flexible arm (3) and the surface (see ‘Modified FIG. 2Ai’ below) of the proximal shield (40) are aligned in (see ‘Modified FIG. 2Ai’ below and see [0064]: protrusions 5 abut shield 40 and therefore must be aligned in the longitudinal direction in order to abut) the longitudinal direction (see longitudinal direction axis shown by arrow in ‘Modified FIG. 2Ai’ below),
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wherein in the intermediate partially-extended position (when the abutment between the protrusion 5 of the arms 3 and shield 40 is removed to allow the proximal shield to move in axial direction, see [0065]), the first surface (see ‘Modified Fig. 2Ai’ above for reference of surface) of the flexible arm (3) and the surface (see ‘Modified Fig. 2Ai’ above for reference of surface) of the proximal shield (40) are offset from one another in the longitudinal direction (see [0065]: abutment is removed and arms move inwardly. Thus, the surfaces are no longer longitudinally aligned) and adjacent to (see [0065]: surfaces only separated by small degree of flex required to move shoulder inward and therefore are adjacent/near to one another) one another in the radial direction (an axis perpendicular or up/down relative to the longitudinal axis), and the second surface (see ‘Modified FIG. 2A’ above for reference of surface) of the flexible arm (3) is adjacent to (surfaces only separated by wall of proximal shield and thus are near to one another) the surface (see distal shield surface in ‘Modified FIG. 2Ai’ above) of the distal shield (30),
wherein in the final compressed position (see Fig. 2B), the surface (see ‘Modified FIG. 2B’ below) of the proximal shield (40)
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is further from (as shown by the length/ distance indicators in ‘Modified FIG. 2B’ above and see [0065]) the proximal end (rightward end, see ‘Modified FIG. 2B’ above) of the proximal shield (40) than the first surface (see ‘Modified FIG. 2B’ above) of the flexible arm (3) is from the proximal end (rightward end, see ‘Modified FIG. 2B’ above) of the proximal shield (40).
Regarding claim 21, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the second surface (see ‘Modified FIG. 2A’ above) of the flexible arm (3) faces away (second surface is outwardly facing/ on an external radial surface) from the axis in the radial direction (an axis perpendicular or up/down relative to the longitudinal axis) and the surface (see ‘Modified FIG. 2A’ above) of the distal shield (30) faces towards (surface of the distal shield is inwardly facing/ on an internal radial surface) the axis in the radial direction (an axis perpendicular or up/down relative to the longitudinal axis).
Regarding claim 23, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the first surface (see ‘Modified Fig. 2Aii’ below)
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of the flexible arm (3) and the surface (see ‘Modified FIG. 2Aii’ above) of the proximal shield (40) are spaced apart (see ‘Modified FIG. 2Aii’ above) in the longitudinal direction (right/left).
Regarding claim 28, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the housing (1, see Fig. 1) is attached to the distal shield (30) by a snap fit (see [0057]) and/or the distal shield is attached to the proximal shield by a snap fit.
Regarding claim 29, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the distal shield (30, see FIG.2A) has a greater radius (30 called an “outer” shield and is shown circumferentially surrounding other components and [0061] says 40 can fall out of 30 if not for the rim31/rib41 engagement and thus 40 must be smaller radially than 30, disclosing 40 as having a greater radius) measured perpendicular to the axis (the longitudinal axis extending horizontally through needle 15 and shown as L in ‘Modified FIG. 2A’ above) than the proximal shield (40).
Regarding claim 30, Schubert discloses the medicament delivery member housing assembly of claim 17, and Shubert further discloses wherein the surface (see distal shield surface in ‘Modified FIG. 2A’ above) facing in the radial direction (surface is inwardly directed in a radial direction) is configured to interact with the second surface of the housing during use so as to move the first surface out of alignment with the surface facing towards the distal end of the medicament delivery member housing assembly (Schubert discloses the surface facing in the radial direction and therefore is “configured to interact with” the second surface as in the 112b rejection above).
Regarding claim 32, Schubert discloses an autoinjector (see [0015] & [0017]) comprising a medicament delivery member housing assembly as claimed in claim 17 (see rejection of claim 17 above).
Regarding claim 33, Schubert discloses a medicament delivery member housing assembly (such as shown in Figs. 1 & 2A-B) extending along an axis in a longitudinal direction (see axis along longitudinal axis of the needle, “L” as seen in ‘Modified Fig. 2A’ below) from a proximal end (see rightward end in ‘Modified FIG. 2A’ below, closest to delivery site, aligning with Applicant disclosure [0004]) to a distal end (see leftward end in ‘Modified FIG. 2A’ below, away from delivery site, aligning with Applicant disclosure [0004]), the medicament delivery member housing assembly comprises:
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a housing (hub 1, see Fig. 1 and [0063]) comprising a body (see ‘Modified Fig. 2A’ above) and a flexible arm (3) that extends in the longitudinal direction from a proximal end (flexible arm 3 extends in the longitudinal direction such as from hinge 4 at a distal end to the protrusion 5 at the proximal end, see Fig. 2A) [[that is movable relative to the body]] to a distal end (hinge 4 see Fig. 2A), the flexible arm (3) [[that]] is attached to the body (see center of needle hub surrounding needle shaft as in ‘Modified Fig. 2A’ above) and moveable relative to (as seen from Fig. 2A-2B and described in [0063] & [0065]) the body (see center of needle hub surrounding needle shaft as in ‘Modified Fig. 2A’ above), where the flexible arm (3) comprises a first surface (see ‘Modified FIG. 2A’ above) facing towards the proximal end (rightward) of the medicament delivery member housing assembly and a second surface (see ‘Modified FIG. 2A’ above) facing in a radial direction (second surface is facing radially outward relative to the longitudinal axis, “L”) relative to the axis (L);
an injection needle (15 with tip 16, see [0060]);
a proximal shield (40) extending around a first end (tip 16) of the injection needle (15), where the proximal shield (40) comprises a surface (see ‘Modified Fig. 2A’ above) facing towards the distal end (leftwardly facing) of the medicament delivery member housing assembly to interact (see [0064]: protrusions 5 abut shield 40 and [0065]: abutment causes force on opposite end of hub at protrusions 6 to cause arms to deflect inwardly) with the first surface (see ‘Modified Fig. 2A’ above) of the [[housing]] flexible arm (3) during use (see [0064-0065]); and
a distal shield (30) extending around a distal end (end 17, see [0060]) of the injection needle (15), the distal shield (30) being slidable in the longitudinal direction relative to (see Fig. 2A to 2B and [0064-0066]) the proximal shield (40), the distal shield (30) comprising a surface (see ‘Modified Fig. 2A’ above) facing in the radial direction (radially inward) to interact with (see 112b rejection above) the second surface (see ‘Modified Fig. 2A’ above) of the [[housing]] flexible arm (3) during use.
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert as applied to claim 17 above, and further in view of Schwirtz et al. (U.S. PGPUB No. 2011/0125100), hereinafter Schwirtz, and Pedersen et al. (U.S. PGPUB No. 2020/0360595), hereinafter Pedersen.
Regarding claim 22, Schubert discloses the medicament delivery member housing assembly of claim 17, but Schubert is silent to “wherein the proximal end of the proximal shield comprises a septum which the medicament delivery member can penetrate, and wherein the distal end of the distal shield comprises a septum which the medicament delivery member can penetrate.”
However, Schwirtz teaches a medicament delivery member housing assembly (see FIG. 3) comprising a proximal shield (27), a distal shield (24) and a housing (23) carrying a medicament delivery member (20), wherein the proximal end (leftward end in FIG. 3 toward patient site 10, see [0071]) of the proximal shield (27) comprises a septum (36, see [0081]) which the medicament delivery member (20) can penetrate (see [0081]: penetrable stopper 36 and [0101]).
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 proximal end of the proximal shield disclosed in Schubert with the penetrable septum as taught by Schwirtz for the purpose of sealing the proximal shield to the outer environment (see [0081]), thus achieving “wherein the proximal end of the proximal shield comprises a septum which the medicament delivery member can penetrate,”.
Schubert in view of Schwirtz remain silent to “and wherein the distal end of the distal shield comprises a septum which the medicament delivery member can penetrate.”
However, Pedersen teaches a medicament delivery member housing assembly (see FIG. 8) comprising a proximal shield (42), a distal shield (20), and a medicament delivery member (15), wherein the distal end (rightward end, see also Fig. 5) of the distal shield (20) comprises a septum (62, see [0092]) which the medicament delivery member (15) can penetrate (see [0093]).
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 distal end of the distal shield disclosed in Schubert to include a penetrable septum as taught by Pedersen for the purpose of keeping the needle cannula sterile when moved into the cartridge (see [0093]), thus achieving “and wherein the distal end of the distal shield comprises a septum which the medicament delivery member can penetrate.”
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Schubert as applied to claim 17 above, and further in view of Helmer et al. (U.S. PGPUB No. 2019/0224424), hereinafter Helmer.
Regarding claim 24, Schubert discloses the medicament delivery member housing assembly of claim 17, but Schubert is silent to “comprising a seal arranged between the proximal shield and the distal shield.”
However, Helmer teaches a medicament delivery member housing assembly comprising a proximal shield (30, see FIG. 6C and [0077])), a distal shield (41), and a medicament delivery member (needle from tips 19 to 18), the housing assembly further comprising a seal (43, see [0077]: an O-ring, aligning with Applicant disclosure) arranged between (as shown in FIG. 6C and described in [0077]) the proximal shield (30) and the distal shield (41).
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 proximal and distal shields disclosed in Schubert to include a seal between as taught by Helmer for the purpose of sealing the space between the two structural elements (see [0077]), thus achieving “comprising a seal arranged between the proximal shield and the distal shield”.
Regarding claim 25, the modified system of Schubert teaches the medicament delivery member housing assembly of claim 24, but Schubert is silent to “wherein the seal is attached to only one of the proximal shield and the distal shield.”
However, Helmer teaches a medicament delivery member housing assembly comprising a seal between a proximal shield (30, see FIG. 6C and [0077])) and a distal shield (41), wherein the seal (43) is attached to only one of the proximal shield (30, see [0077]: O-ring provided to 30 by 2k or two-shot injection molding process) and the distal shield.
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 proximal shield disclosed in Schubert to include an attached seal as taught by Helmer for the purpose of sealing the space between the proximal and distal shields (see [0077]), thus achieving “wherein the seal is attached to only one of the proximal shield and the distal shield.”.
Regarding claim 26, the modified system of Schubert teaches the medicament delivery member housing assembly of claim 25, but Schubert is silent to “wherein the one of the proximal shield and the distal shield that the seal is not attached to comprises a recess, and the seal extends into the recess.”
However, Helmer teaches a medicament delivery member housing assembly comprising a seal between a proximal shield (30, see FIG. 6C and [0077])) and a distal shield (41), wherein the seal (43) is attached to only one of the proximal shield (30, see [0077]: O-ring provided to 30 by 2k or two-shot injection molding process) and the distal shield, wherein the one of the proximal shield and the distal shield (41) that the seal (43) is not attached to (see [0077]: 43 attached to 30) comprises a recess (see ‘Modified FIG. 6C’ below), and the seal (43) extends into (in a longitudinal direction) the recess (see ‘Modified FIG. 6C below).
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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 distal shield disclosed in Schubert to include a recess for a seal to extend into as taught by Helmer for the purpose of sealing the space between the proximal and distal shields (see [0077]), thus achieving “wherein the one of the proximal shield and the distal shield that the seal is not attached to comprises a recess, and the seal extends into the recess.”
Regarding claim 27, the modified system of Schubert teaches the medicament delivery member housing assembly of claim 25, but Schubert is silent to “wherein the one of the proximal shield and the distal shield that the seal is not attached to comprises a protrusion extending in the radial direction, and the seal abuts the protrusion.”
However, Helmer teaches a medicament delivery member housing assembly comprising a seal between a proximal shield (30, see FIG. 6C and [0077])) and a distal shield (41), wherein the seal (43) is attached to only one of the proximal shield (30, see [0077]: O-ring provided to 30 by 2k or two-shot injection molding process) and the distal shield, wherein the one of the proximal shield and the distal shield (41) that the seal (43) is not attached to (see [0077]: 43 attached to 30) comprises a protrusion (radial edge as shown in ‘Modified FIG. 6Ci’ below) extending in the radial direction (protrusions as shown below radially extended from other radial portions of shield 41, such as shown by radial portion of 26 shown in ‘Modified FIG. 6Ci’ below), and the seal (43) abuts the protrusion (see ‘Modified FIG. 6Ci’ below and [0077]).
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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 distal shield disclosed in Schubert to include a protrusion to abut the seal as taught by Helmer for the purpose of sealing the space between the proximal and distal shields (see [0077]), thus achieving “wherein the one of the proximal shield and the distal shield that the seal is not attached to comprises a protrusion extending in the radial direction, and the seal abuts the protrusion.”
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert as applied to claim 17 above, and further in view of Cowe et al. (U.S. PGPUB No. 2019/0358401), hereinafter Cowe.
Regarding claim 31, Schubert a medicament delivery member housing assembly as described in claim 17 (see claim 17 rejection above), but is silent to “a cassette comprising” a medicament delivery member housing assembly as described in claim 17.
However, Cowe teaches a cassette (104, see FIG. 12(a) and [0105]: cassette body 104 not shown in FIGs. 12(a/b)) comprising (cassette provided with needle assembly via coupling 24) a medicament delivery member housing assembly with a proximal shield (172), a distal shield (186), and a housing (112, see [0074]) carrying a medicament delivery member (118).
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 medicament delivery member housing assembly disclosed in Schubert to be attachable to a cassette as taught by Cowe, such as by providing a sterile coupling element (see [0074]) for the purpose of providing a cassette with the housing that has a sterile needle insertion mechanism that protects against needle sticks (see [0023-0025] and [0074]), thus achieving “a cassette comprising” a medicament delivery member housing assembly as described in claim 17.
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Schubert as applied to claim 33 above, and further in view of Schwirtz (U.S. PGPUB No. 2011/0125100).
Regarding claim 34, Schubert discloses the medicament delivery member housing assembly of claim 33, but Schubert is silent to “wherein a seal is attached to the proximal shield.”
However, Schwirtz teaches a medicament delivery member housing assembly (see FIG. 3) comprising a proximal shield (27), a distal shield (24) and a housing (23) carrying a medicament delivery member (20), wherein a seal (36, see [0081]) is attached to (see at least [0081], [0085], & [0096]) the proximal shield (27).
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 proximal shield disclosed in Schubert to have a seal attached thereto as taught by Schwirtz for the purpose of sealing the proximal shield to the outer environment (see [0081]), thus achieving “wherein a seal is attached to the proximal shield.”
Regarding claim 35, the modified system of Schubert teaches the medicament delivery member housing assembly of claim 34, but Schubert is silent to “wherein the seal positioned within a recess located at a proximal end face of the proximal shield.”
However, Schwirtz teaches a medicament delivery member housing assembly (see FIG. 3) comprising a proximal shield (27), a distal shield (24) and a housing (23) carrying a medicament delivery member (20), wherein a seal (36, see [0081]) is attached to (see at least [0081], [0085], & [0096]) the proximal shield (27) and wherein the seal (36) is positioned within a recess (see annular recess in ‘Modified FIG. 3’ below of the front support of the opening 35, see [0085] &[0096])
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located at a proximal end face (see ‘Modified FIG. 3’ above) of the proximal shield (27).
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 proximal shield disclosed in Schubert to include a seal positioned within a recess located at a proximal end face of the proximal shield as taught by Schwirtz for the purpose of sealing the proximal shield to the outer environment (see [0081]) and/ or to use the seal to form a damping function (see [0102]), thus achieving “wherein the seal positioned within a recess located at a proximal end face of the proximal shield.”
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Schwirtz as applied to claim 35 above, and further in view of Pedersen (U.S. PGPUB No. 2020/0360595).
Regarding claim 36, the modified system of Schubert teaches the medicament delivery member housing assembly of claim 35, but Schubert is silent to “wherein seal comprises a septum and the distal end of the distal shield comprises a septum.”
However, Schwirtz teaches a medicament delivery member housing assembly (see FIG. 3) comprising a proximal shield (27), a distal shield (24) and a housing (23) carrying a medicament delivery member (20), wherein a seal (36, see [0081]) is attached to (see at least [0081], [0085], & [0096]) the proximal shield (27), and wherein seal comprises a septum (see [0081]: 36 described as penetrable sealing stopper).
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 proximal shield disclosed in Schubert to have a seal attached thereto as taught by Schwirtz for the purpose of sealing the proximal shield to the outer environment (see [0081]), thus achieving “wherein seal comprises a septum”
Schubert in view of Schwirtz remain silent to “and the distal end of the distal shield comprises a septum”.
However, Pedersen teaches a medicament delivery member housing assembly (see FIG. 8) comprising a proximal shield (42), a distal shield (20), and a medicament delivery member (15), wherein the distal end (rightward end, see also Fig. 5) of the distal shield (20) comprises a septum (62, see [0092-0093]: penetrable septum).
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 distal end of the distal shield disclosed in Schubert to include a septum as taught by Pedersen for the purpose of keeping the needle cannula sterile when moved into the cartridge (see [0093]), thus achieving “and the distal end of the distal shield comprises a septum”.
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