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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) and/or PCT Article 7, Paragraph (1). The drawings must show every feature of the invention specified in the claims, when they are necessary for the understanding of the invention. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
the clutch hub; see 112(b) rejection below for clarification
No new matter should be entered.
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because they fail to comply with the following PCT Rule 11.2 sections.
New corrected drawings in compliance with 11.2(a) are required in this application because the line and text quality, particularly in Figures 1-5 , 7-9 & 15-19, prevents satisfactory reproduction characteristics
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because they fail to comply with the following PCT Rule 11.13 sections.
New corrected drawings in compliance with 11.13(a) are required in this application because the line and text quality, particularly in Figures 1-5 , 7-9 & 15-19, makes it difficult to determine the structure of the claimed invention; the poor line and text quality also make it difficult to determine which structure the lead lines are pointing to
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.
Claim Objections
Claims 5-10 are objected to because of the following informalities.
Claim 5 should read --The multi-dose adjustable pre-filled injection pen according to claim 4, further comprising an end button, wherein a circumference of the end button is fitted into the end limiting member, a force transmission cylinder extending in the injection direction is arranged in a middle of the end button, and a front end of the force transmission cylinder abuts against the end limiting member and is spherical.--
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 1-10 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.
As to Claim 1, the limitation “the push rod sleeve is in a sliding fit with the injection push rod in the injection direction, which is configured to transmit a torque in a direction of screwing-in of the injection push rod”, in Lines 10-11, is indefinite. It is not clear which structure is transmitting the described torque. For the purpose of examination, the push rod sleeve will be interpreted to transmit a torque to the injection push rod.
The limitation “the push rod sleeve is connected to the pen body through a first set of ratchet pawl mechanisms”, in Lines 12-13, is indefinite. The instant application only shows push rod sleeve 7 connected to pen body 4/15 via a single ratchet pawl mechanism comprised of ratchets 42 and pawls 72, as described in Paragraph 0058. As such, it is not clear what structure constitutes a second ratchet pawl mechanism which would create the claimed mechanisms –plural. For the purpose of examination, the limitation will be interpreted as the push rod sleeve is connected to the pen body through a first ratchet pawl mechanism.
The limitation “the dose hub is rotatably connected to the pen body through threads, and is configured to be pushed to screw in by driving axially”, in Lines 17-18, is indefinite. It is not clear what structure the dose hub is being screwed into in the second part of the limitation. For example, the dose hub could be screwed into the pen body, or the dose hub could be screwed into an undefined structure. For the purpose of examination, the limitation will be interpreted as the dose hub is configured to be pushed to screw into the pen body by driving the dose hub axially.
The limitation “relative rotation between the clutch hub and the dose hub is precluded by a clutch structure which disengages in the injection direction”, in Lines 19-20, is indefinite. It is not clear what structure comprises the claimed clutch structure, in light of the specification. Instant application Paragraph 0048 describes the support foot 83 as engaging with the clutch structure. Instant application Paragraph 0052 describes support foot 83 engaging with ratchets 141 on dose hub 14, but no other description of the clutch structure is provided. As such, it is not clear what constitutes the clutch structure, rendering the claim indefinite. For the purpose of examination, the clutch structure will be interpreted as ratchets 141.
The limitation “the clutch structure is prevented from disengaging by the support foot, which results from the deformation of the support foot due to the fact that the end limiting member is subjected to a thrust in the injection direction”, in Lines 23-25, is indefinite. As described above, it is not clear which structure constitutes the clutch structure. As such, it is not clear how the clutch structure is capable of being prevented from disengaging with anything via the support foot. It is not clear which structure the clutch structure is prevented from being disengaged from, or how the clutch structure is disengaged by the foot. It is not clear how the support foot deforms due to a thrust in the injection direction.
The term “the deformation” lacks antecedent basis.
It is not clear how the phrase “due to the fact” further limits the limitation. Additionally, the term “the fact” lacks antecedent basis. Examiner recommends removing this phrase, since the phrase appears to be superfluous.
For the purpose of examination, the limitation will be interpreted as the clutch structure is prevented from disengaging with the support foot, which results in a deformation of the support foot due to the end limiting member being subjected to a thrust in the injection direction, where the clutch structure is interpreted as ratchets 141, as described above.
The limitation “the clutch structure is configured to be pushed to disengage by rotation of the dose hub before the support foot deforms elastically”, in Lines 26-27, is indefinite. As described above, it is not clear which structure constitutes the clutch structure. As such, it is not clear how the clutch structure is capable of being pushed to disengage from any structure. It is not clear which structure the clutch structure is being disengaged from, or how the clutch structure is disengaged. Lastly, it is not clear how the clutch structure may be disengaged before the support foot deforms, since it is not clear what the clutch structure is, how the clutch structure is disengaged, or what the structure the clutch structure disengages with.
As to Claim 3, the limitation “a ratchet fitting with the pawl of the support foot is arranged at an end of the dose hub, to preclude relative rotation in the direction of screwing-in”, is indefinite. In light of the Claim 1 rejection, it is not clear if the claimed ratchet fitting in Claim 3 is the same structure as the “clutch structure” of Claim 1, or if the respective structures are different structures. Additionally, it is not clear what structures are precluded from relative rotation. For the purpose of examination, the “ratchet fitting” of Claim 3 will be interpreted as the “clutch structure” of Claim 1, and the preclusion of relative rotation is between the support foot and dose hub.
As to Claim 4, the limitation “the rear end of the clutch hub and the end limiting member are connected through a second set of ratchet pawl mechanisms” is indefinite. The instant application only shows clutch hub 6 connected to end limiting member 8 via a single ratchet pawl mechanism comprised of ratchets 84 and pawls 63, as described in Paragraph 0055. As such, it is not clear what structure constitutes a second ratchet pawl mechanism which would create the claimed mechanisms –plural. For the purpose of examination, the limitation will be interpreted as the rear end of the clutch hub and the end limiting member are connected through a second ratchet pawl mechanism.
As to Claim 7, the limitation “the injection push rod, the push rod sleeve, the clutch hub, the dose limiting nut, the dose hub and the body barrel are arranged in sequence with the latter sleeved on the former one by one” is indefinite.
The terms “the latter” and “the former” lack antecedent basis.
Additionally, it is not clear which structure is being referred to by either of the terms “the latter” or “the former”. Any of the push rod, the clutch hub, the dose limit nut, the dose hub, or the body barrel would be considered to be the latter, when compared to any of the other defined structure, including the injection push rod. Any of the injection push rod, the push rod, the clutch hub, the dose limit nut, or the dose hub would be considered to be the former, when compared to any of the other defined structure, including the body barrel. As such, it is not clear which structure is being referred to, if only one claimed structure is being referred to per term, if multiple claimed structures are being referred to per term, or of the respective terms refer to structure not previously defined.
Lastly, it is not clear what is meant by the phrase “arranged in sequence…one by one”. It is not clear which structure is referred to for each instant of the term “one”.
For the purpose of examination, the limitation will be interpreted as the injection push rod, the push rod sleeve, the clutch hub, the dose limiting nut, the dose hub and the body barrel are arranged radially in sequence.
As to Claim 9, the limitation “the vial ring is configured to abut against a vial in the vial holder at a front end and abut against the pen body at a rear end” is indefinite. It is not clear which structure is being referenced with the terms “a front end” or “a rear end”. For the purpose of examination, the limitation will be interpreted as a front end of the vial ring is configured to abut against a vial in the vial holder, and a rear end of the vial ring is configured to abut against the pen body.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geng (CN209548480U – see attached translation).
As to Claim 1, Geng teaches a multi-dose adjustable (Paragraph 0041/0044, where one of ordinary skill in the art would realize multiple doses may be provided depending on the dosage setting used) pre-filled (Paragraph 0039) injection pen (Figure 1), comprising: a pen body (1/12);
an injection push rod (4);
a push rod sleeve (11);
a clutch hub (10);
an end limiting member (7); and
a dose hub (9); wherein
the injection push rod (4) is connected to (via the “threaded engagement structure” described in Paragraph 0043) the pen body (1/12) through threads (as described in Paragraph 0043) having an axis (up and down through the center of push rod nut 12, as viewed in Figure 2) extending in (as shown in Figure 2) an injection direction (down, as viewed in Figure 2),
the push rod sleeve (11) is in a sliding fit with (Paragraph 0043) the injection push rod (4) in the injection direction (down, as viewed in Figure 2), which is configured to transmit a torque (via push rod sleeve rotating push rod nut 12, as described in Paragraph 0043) in a direction of screwing-in (the “opposite direction” described in Paragraph 0043 which results in push rod sleeve 4 moving “axially forward”) of the injection push rod (4),
the push rod sleeve (11) is connected to (via ratchet 95 and pawl 96, as described in Paragraph 0043) the pen body (1/12) through a first set of ratchet pawl mechanisms (95/96), which precludes (Paragraph 0043 describes pawl 96 as “one-way” which would lead one of ordinary skill in the art to conclude pawl 96 “precludes” push rod sleeve 11 from rotating in the direction opposite to the “opposite direction” –i.e., the direction of screwing-out) the push rod sleeve (11) from rotating (as described in Paragraph 0043), relative to the pen body (1/12), in a direction of screwing-out (the rotational direction opposite to the “opposite direction” described in Paragraph 0043 which would result in push rod sleeve 4 moving axially backwards) of the injection push rod (4),
the clutch hub (10) is in a sliding fit with (via the keyway structure described in Paragraph 0041) the push rod sleeve (11) in the injection direction (down, as viewed in Figure 2), and relative rotation between the clutch hub (10) and the push rod sleeve (11) is precluded (as described in Paragraph 0042),
the dose hub (9) is rotatably connected to (as described in Paragraph 0032) the pen body (1/12) through threads (Paragraph 0032 describes dose hub 9 being “threadingly connected to” pen body (1/12), and is configured to be pushed (via end button 8) to screw in (via the threads described in Paragraph 0032) by driving (via end button 8 causing dose hub 9 to “move axially forward”, as described in Paragraph 0043) axially (up and down, as viewed in Figure 2),
relative rotation between the clutch hub (10) and the dose hub (9) is precluded (via support foot 77 engaging with ratchet 93, as described in Paragraph 0037) by a clutch structure (93) which disengages (as described in Paragraph 0041) in the injection direction (down, as viewed in Figure 2),
a support foot (77) elastically deformable (Paragraph 0037 describes support foot 77 as a spring , which one of ordinary skill in the art would interpret as “elastically deformable”) in (one of ordinary skill in the art would conclude support foot 76 is always elastically deformable, regardless of the direction) the injection direction (down, as viewed in Figure 2) is braced between (Figure 2 shows end limiting member radially within dose hub 9; Figures 5/6 show support foot 77 on the radially outer side of end limiting member 7; as such, one of ordinary skill in the art would conclude support foot 77 is braced –via being attached to end limiting member—between end limiting member 7 and dose hub 9) the end limiting member (7) and the dose hub (9),
the clutch structure (93) is prevented from disengaging (via end button 8 causing dose hub 9 to “move axially forward”, as described in Paragraph 0043) by the support foot (77), which results from the deformation (via support foot 77 engaging with clutch structure 93) of the support foot (77) due to the fact that the end limiting member (7) is subjected to a thrust (the thrust caused by pressing end button 8, as described in Paragraph 0043) in the injection direction (down, as viewed in Figure 2), and
the clutch structure (93) is configured to be pushed (via rotating in the opposite direction, as described in Paragraph 0043) to disengage (as described in Paragraph 0043) by rotation (as described in Paragraph 0043) of the dose hub (9) before the support foot (77) deforms elastically (where support foot 77 is “pressed”, which one of ordinary skill in the art would interpret as deformed elastically).
As to Claim 2, Geng teaches all the limitations of Claim 1, and continues to teach a dose limiting nut (5), wherein the dose limiting nut (5) is connected to (Paragraph 0034) the clutch hub (10) by threads (where spiral protrusions 14 would be interpreted by one of ordinary skill in the art as threads) and in a sliding fit (Paragraphs 0034/0044) with the dose hub (9) in the injection direction (down, as viewed in Figure 2), relative rotation between the dose limiting nut (5) and the dose hub (9) is precluded (via 94; Paragraph 0034), and the dose limiting nut (5) is moved along (Paragraph 0044) an axial direction (up and down, as viewed in Figure 2) of the clutch hub (10) when the dose hub (9) is rotated relative to (as the user rotates dose hub 9, protrusion 94 will rotate dose limiting nut 5 –due to being interlocked with dose limiting nut 5, as described in Paragraph 0034; this rotation will cause dose limiting nut to axially translate due to being connected to spiral protrusions 14 on clutch hub 10) the clutch hub (10).
As to Claim 3, Geng teaches all the limitations of Claims 1-2, and continues to teach a pawl (74) is arranged at a tip (the end of 77, as described in Paragraph 0037) of the support foot (76), and a ratchet fitting (93) with the pawl (74) of the support foot (77) is arranged at (as shown in Figure 7) an end (the top end of 9, as viewed in Figure 7) of the dose hub (9), to preclude relative rotation (one of ordinary skill in the art would conclude ratchet fitting would prevent relative rotation between support foot 77 and dose hub 9, as described in Paragraph 0042) in the direction of screwing-in (the “opposite direction” described in Paragraph 0043 which results in push rod sleeve 4 moving “axially forward”);
the end limiting member (7) is provided with a limiting flange (75), and the dose hub (9) is correspondingly provided with (as show in Figure 8) a limiting groove (see Figure 8 below) enclosing (as shown in Figure 2) the limiting flange (75) to limit a range of movement (the range between the top and the bottom of the groove shown in Figure 8 below) of the limiting flange (75) in the injection direction (down, as viewed in Figure 2).
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Geng Figure 8, Modified by Examiner
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Geng.
As to Claim 4, Geng teaches all the limitations of Claims 1-3, and continues to teach a protruding disc (see Figure 4 below) is arranged at (as shown in Figure 4) a rear end (the top end of 10, as viewed in Figure 4) of the clutch hub (10),
a plurality (Paragraph 0036) of protrusions (16) circumferentially evenly distributed (as shown in Figures 3/4) are arranged at (as shown in Figure 4) a front side (the bottom of the protruding disc, as viewed in Figure 4) of the protruding disc (see Figure 4 below),
an annular shoulder (the step described in Paragraph 0036) is arranged inside (as shown in Figure 7) a rear end (the top end of 9, as viewed in Figure 7) of the dose hub (9), tooth grooves (the grooves between teeth 92, as viewed in Figure 7) circumferentially distributed (as shown in Figure 7) and fitting with (Paragraph 0036) the protrusions (16) are arranged at (as shown in Figure 7) a rear side (the top of the shoulder at the top end of 9, as viewed in Figure 7) of the annular shoulder (the step described in Paragraph 0036); and
the rear end (the top end of 10, as viewed in Figure 4) of the clutch hub (10) and the end limiting member (7) are connected through (via ratchet 76/74 and pawl 96, as described in Paragraph 0043) a second set of ratchet pawl mechanisms (15/76/74).
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Geng Figure 4, Modified by Examiner
Geng does not teach the protrusions on the protruding disc or the grooves on the annular shoulder are arc-shaped.
It would have been obvious to one of ordinary skill in the art at the time of invention to make the protrusions and grooves, as taught by Geng, to be arc-shaped. As described by Geng Paragraph 0043, there is a need to mesh the protrusions and grooves to cause the push rod sleeve 11 to rotate. Since there are only a finite number of shapes which allow for meshing in this manner, – i.e., arc-shaped, squared, trapezoid, or ridge-shaped– and each option will lead to a reasonable expectation of success, it would have been obvious to one of ordinary skill in the art to try one of them to allow for engagement and disengagement between the protrusions and grooves. MPEP 2143(I)(E)
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Geng, in view of Schiffman (CH709878A2 – see attached translation).
As to Claim 5, Geng, as modified, teaches all the limitations of Claims 1-4, and continues to teach an end button (8) with a force transmission cylinder (the portion of end button 8 surrounding post 71 –see Figure 5—in Figure 2) extending (as shown in Figure 2) in the injection direction (down, as viewed in Figure 2) is arranged in (as shown in Figure 2) the middle of the end button (8), where the force transmission cylinder surrounds the end limiting member 7 post 71.
Geng, as modified, does not teach each of the relationship features of the force transmission cylinder with the end limiting member, so does not teach a circumference of the end button is fitted into the end limiting member…and a front end of the force transmission cylinder abuts against the end limiting member and is spherical.
Schiffman describes a similar injection pen (see Figures 12a/12b), and teaches a circumference (the outer circumference of the force transmission cylinder shown in Figure 12a below) of the end button (21) is fitted into (as shown in Figure 12a) the end limiting member (7)…and a front end (the bottom of the force transmission cylinder shown in Figure 12a below) of the force transmission cylinder (see Figure 12a below) abuts against (as shown in Figure 12a) the end limiting member (7) and is spherical (as shown in Figure 12a).
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Schiffman Figure 12a, Modified by Examiner
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the force transmission cylinder of the end button and the end limiting member, as taught by Geng, as modified, so the force transmission cylinder is surrounded by the end limiting member, as taught by Schiffman. One of ordinary skill in the art would conclude this modification reduces friction during rotation between the end button and end limiting member, and provides additional guidance during assembly.
As to Claim 6, Geng, as modified, teaches all the limitations of Claims 1-5, and continues to teach the pen body (Geng 1/12) comprises a body barrel (Geng 1) and a push rod nut (Geng 12) fitted into (as shown in Geng Figure 2) the body barrel (Geng 1), wherein the push rod nut (Geng 12) is connected to (as shown in Geng Figure 2) the injection push rod (Geng 4) by threads (Geng Paragraph 0033) and connected to (as shown in Geng Figure 9) the push rod sleeve (Geng 11) through (Geng Paragraph 0038) the first set of ratchet pawl mechanisms (Geng 95/96).
As to Claim 7, Geng, as modified, teaches all the limitations of Claims 1-6, and continues to teach the injection push rod (Geng 4), the push rod sleeve (Geng 11), the clutch hub (Geng 10), the dose limiting nut (Geng 5), the dose hub (Geng 9) and the body barrel (Geng 1) are arranged in sequence (as shown in Geng Figure 2) with the latter sleeved on the former one by one (see 112(b) above for interpretation clarification).
As to Claim 8, Geng, as modified, teaches all the limitations of Claims 1-7, and continues to teach a window (see Geng Figure 1 below) is provided on (as shown in Figure 1) the pen body (Geng 1/12), and spirally distributed (as shown in Geng Figure 7) scales (the scales shown on dose hub 9, as shown in Geng Figure 7) are provided at (as shown in Geng Figure 7) an outer side (the outer surface of Geng dose hub 9 with scales, as viewed in Geng Figure 7) of the dose hub (Geng 9) to pass through the window in sequence (one of ordinary skill in the art would conclude the scales shown in Geng Figure 7 would pass through –i.e., be visible through—the window –shown in Geng Figure 1 below—as Geng dose hub 9 is rotated in either direction) when the dose hub is screwed in (via the threads between Geng dose hub 9 and Geng pen barrel 1, described in Geng Figure 0032).
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Geng Figure 1, Modified by Examiner
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Geng, in view of Schiffman, further in view of Cronenberg (U.S. PGPub 2012/0283647), further in view of Avery (U.S. PGPub 2018/0021518).
As to Claim 9, Geng, as modified, teaches all the limitations of Claims 1-8, and continues to teach a vial holder (see Geng Figure 1 in the Claim 8 rejection above) clamped at (via the protrusions at the top of the vial holder, as shown in Geng Figure 1 in the Claim 8 rejection above) a front end (the bottom end of Geng body barrel 1, as viewed in Geng Figure 1) of the body barrel (Geng 1)…
a rotatable (one of ordinary skill in the art would conclude Geng push rod knob 6 is rotatable, since Geng injection push rod 4 rotates –as described in Geng Paragraph 0033) push rod knob (Geng 6)…is provided at (as shown in Geng Figure 2) a front end (the bottom end of Geng injection push rod 4, as viewed in Geng Figure 2) of the injection push rod (Geng 4).
Geng, as modified, continues to teach the use of a stopper, but is silent on how the stopper is used with respect to the push rod knob, so does not explicitly teach the rotatable push rod knob configured to abut against a vial stopper.
Geng, as modified, also teaches what appears to be a threaded post (see Geng Figure 1 in the Claim 8 rejection above) for a needle, but is silent on the intended use of the probably threaded post, so does not explicitly teach a threaded post is provided at a front end of the vial holder for attaching a needle.
Geng, as modified, does not teach a vial ring is arranged at a rear end of the vial holder; the vial ring is configured to abut against a vial in the vial holder at a front end and abut against the pen body at a rear end.
Cronenberg describes a similar injection pen (see Figures 12a/12b), and teaches the rotatable push rod knob (16) configured to abut against (Paragraph 0043) a vial stopper (40).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to abut the rotatable push rod knob, as taught by Geng, as modified, against the stopper, as taught by Cronenberg, “to expel the medication from the [vial] (Paragraph 0043).”
Cronenberg continues to teach a threaded post (42; see Figure 2A) is provided at (as shown in Figure 2A) a front end (the right side of 14, as viewed in Figure 2A) of the vial holder (14) for attaching (as described in Paragraph 0043) a needle (5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the probable threaded post, as taught by Geng, as modified, a threaded post, as taught by Cronenberg, to provide a means for attaching a needle to inject medicine.
Cronenberg continues to teach a vial ring (124) is arranged at (as shown in Figure 11F) a rear end (the left side of 36, as viewed in Figure 11F) of the vial holder (36); the vial ring (124) is configured to abut against (Paragraph 0069) a vial (36) in (as shown in Figure 11F) the vial holder (14) at a front end (the right side of 36, as viewed in Figure 11F) and abut against (as shown in Figure 11F) the pen body (32’) at a rear end (the left side of 36, as viewed in Figure 11F).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a vial ring, as taught by Cronenberg, between the vial holder and pen body, as taught by Geng, as modified, “to maintain the positioning of [the pen body] (Paragraph 0069)”, and “to prevent the cartridge from moving (Paragraph 0069)”.
Avery describes a similar injection pen (see Figures 1-3), and teaches the vial stopper (101) is made of rubber (Paragraph 0110).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the stopper, as taught by Geng, as modified, from rubber, as taught by Avery, since injection pens using rubber stoppers are well-known, and yields predictable results, i.e., are easily manufactured, and provide a reliable seal while being axially moved.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of filing to make the stopper, as taught by Geng, as modified, from rubber, as taught by Avery, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
As to Claim 10, Geng, as modified, teaches all the limitations of Claims 1-9, and continues a pen cap (see Geng Figure 1 in the Claim 8 rejection above), wherein a rear end (the top of the pen cap shown in Geng Figure 1 in the Claim 8 rejection above) of the pen cap (see Geng Figure 1 in the Claim 8 rejection above) is snap-fitted (via the protrusions at the rear end of the pen cap, as shown in Geng Figure 1 in the Claim 8 rejection above) to the vial holder (see Geng Figure 1 in the Claim 8 rejection above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Knowles (2021/0402099) describes a similar injector pen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783