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 .
Specification
The disclosure is objected to because of the following informalities:
paragraph 0052, there is no figure 3B
paragraph 0066, “drive chassis 34” should instead be “drive chassis 24”
paragraph 0068, spelling error “transvers direction”
paragraph 0085, “plunger 26of” missing space between “26” and “of”
paragraph 0089, “could printed” should read “could be printed”
paragraph 0093, “mounted axially moveable” should read as “mounted to be axially moveable”
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 9, 11, and 12 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 9 recites the limitation “…the trigger limb…”. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 depends from claim 5, which gave two alternatives (i.e. “wherein the syringe window shows at least one of a plunger arranged within the pre-filled syringe and a dispensing limb in the pre-filled syringe after use of the autoinjector”). Claim 9 further limits one of the alternatives, but is unclear as to whether this means the second alternative is required or still an option. Until this is clarified, the latter will be assumed.
Claim 11 recites the limitations “…the dispensing limb…” and “…the trigger limb…”. There is insufficient antecedent basis for these limitations in the claim.
As to claim 12, the word of “approximately the same height” is unclear. The “height” of the syringe window’s and status indicator window’s distal ends may be taken with respect to multiple different axes, and as such it is not clear what the intent of the position of these ends should be.
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.
(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 1-7, 9, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190290852 A1, henceforth written as Helmer.
Regarding Claim 1:
An autoinjector comprising: a housing (fig 1, housing 1.2 10.2) in which a pre-filled syringe (container 1.3 10.3, paragraph 51) is arranged (the container 1.3 10.3 is arranged within the syringe carrier 15 which is arranged within housing 1.2 10.2, paragraph 58);
a drive chassis (fig 1, chassis is comprised of movable component 1.1 & 10.1, needle sleeve/shroud 13, piston rod 14, and syringe carrier 15, paragraph 52) mounted in the housing, the drive chassis being biased (drive spring (not shown in figures), paragraph 53) with respect to the housing and being fixed with respect to the housing in a storage state of the autoinjector (paragraph 54, 59);
a status indicator window (state indicator 2) arranged at the housing via which the drive chassis (piston rod 4) is visible from outside (fig1c, paragraph 66-67,
with the status indicator window showing a first part of the drive chassis (fig 1c/5/6 movable component 1.1, Mark M1-Mn) in the storage state of the autoinjector and a second part of the drive chassis (mark Mn) after use of the autoinjector (paragraph 74-75),
with the first and second parts (fig 5/6, mark M1- Mn) of the drive chassis (movable component 1.1) being distinguishable from one another (paragraph 89-93);
and a syringe window (fig 1c, drug window 6) arranged at the housing via which the pre-filled syringe is visible from the outside (paragraph 68),
with the syringe window (fig 1c, drug window 6, paragraph 68) showing at least a third part of the drive chassis (piston 4.1, container 1.3, paragraph 75) different from the first and second parts of the drive chassis after use of the autoinjector (piston 14.1 is visible through the drug window 6 after use, as shown in fig 1b).
Regarding Claim 2:
The autoinjector according to claim 1, wherein the status indicator window (fig 1c, state indicator 2) is an elongate slot extending radially around a part of the housing (fig 1c-d show state indicator 2 being of elongate shape and extending around some part of the circumference of the housing 1.2).
Regarding Claim 3:
The autoinjector according to claim 1, wherein the first and second parts of the drive chassis (fig 5,6 mark M1- Mn) are distinguishable from one another due to a visual difference, a difference in colour, a printed label applied at a surface of the drive chassis, a text applied on the surface of the drive chassis or an icon displayed in the surface of the drive chassis (paragraph 74).
Regarding Claim 4:
The autoinjector according to claim 1, wherein the syringe window (fig 1C, drug window 6) is configured to show a content filled in the pre-filled syringe in the storage state of the autoinjector (fig 1c, paragraph 68 “drug window/s 6 allow/s a view on the container 1.3, in particular on the drug in the container 1.3” until the drive chassis has forced the medicament from the container).
Regarding Claim 5:
The autoinjector according to claim 1, wherein the syringe window (fig 1C drug window 6) is configured to show at least one of a plunger (piston 4.1) arranged within the pre-filled syringe (paragraph 68, 73)
and a dispensing limb in the pre-filled syringe after use of the autoinjector.
As described above, the syringe window as claimed is configured to show a plunger and/or a dispensing limb in the pre-filled syringe after use of the autoinjector. As the plunger, piston 4.1 in Helmer, is shown, a dispensing limb need not be visible for the claim to be rejected.
Regarding Claim 6:
The autoinjector according to claim 1, wherein the syringe window (fig 1C drug window 6 fig 1A drug window 60) is of elongate shape and a length of the elongate shape extends in an axial direction of the autoinjector (paragraph 69, fig 1c and 1a show the drug window 6 60 is of a shape that extends some length of the syringe’s injection axis greater than its width).
Regarding Claim 7:
The autoinjector according to claim 1, wherein an elongate shape of the syringe window (fig 1c drug window 6) is arranged transverse to an elongate shape of the status indicator window (fig 1c state indicator 2).
Fig 1c of Helmer show the greater length of drug window 6 is arranged transverse to the greater length of state indicator 2, as defined by the axes provided in applicant’s disclosure, see examiner’s figure below.
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Regarding Claim 9:
The autoinjector according to claim 5, wherein the dispensing limb and the trigger limb are connected one to another via a web.
Claim 9 further limits the plunger alternative, a dispensing limb, which per Claim 5, need not be present in the claimed invention. Therein claim 9 is rejected by the merits of rejecting claim 5 with the alternative embodiment (see rejections under 35 USC § 112(b) above).
Regarding Claim 12:
The autoinjector according to claim 1, wherein a distal end of the syringe window (fig 1c drug window 6) is arranged at approximately a same height as a distal end of the status indicator window (fig 1c state indicator 2).
See examiner’s figure below.
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The distal end of the state indicator 2 and drug window 6, illustrated with thick outlines and arrows pointing toward them, are approximately the same height from the axis provided in the figure.
Regarding Claim 14:
The autoinjector according to claim 1, wherein the first and second parts of the drive chassis are not visible in the syringe window (fig 1a-c).
Windows are transversely oriented with non-overlapping portions therefore each window's view of the drive chassis can be exclusive to its position on the autoinjectors transverse axis.
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.
Claims 8, 10-11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer as applied to claim 1 above, in view of EP 2705861 A1, henceforth written as Carrel (cited in parent case 17587824 on 12/20/23, another copy has been provided with this office action).
Regarding Claim 8:
Helmer discloses all of the elements of the current invention which claim 8 is dependent upon, as described above. However, Helmer does not disclose:
the drive chassis comprising a trigger arm engaging a stop feature in the house while the autoinjector is in a storage state,
with the trigger arm extending from a trigger limb,
and the 1st and 2nd parts of the drive chassis being arranged at or in the trigger limb,
Carrel teaches the drive chassis comprises a trigger arm (fig 1a-c distal leg 27) engaging a stop feature (flexible hook 13) in the housing in the storage state of the autoinjector (fig 1A-C paragraph 83 “In the storage position of the device 1…distal leg 27 of the plunger rod 20 being engaged in flexible hook 13 of the syringe holder 10”, paragraph 90),
the trigger arm (distal leg 27) extends from a trigger limb (longitudinal tubular lodging 23)
the first (first helical spring 8) and second parts (lever member 70) of the drive chassis are arranged at or in the trigger limb (fig 1a-c).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to apply Carrel's teaching of an autoinjector drive chassis’ trigger arm engaging a stop feature during a storage state and the arrangement and the first & second parts of the drive chassis being in the trigger limb to the means of conveying syringe status and injection state directed by Helmer in order to safely maintain and consequently inform the user of the use status of the product.
Regarding Claim 10:
Helmer discloses all of the elements of the current invention which claim 10 is dependent upon, as described above. However, Helmer fails to disclose the drive chassis being generally U-shaped.
Carrel teaches the drive chassis is generally U-shaped (shaft 21 bridge 22 longitudinal tubular lodging 23 members of drive chassis form U-shape per fig 3A-C paragraph 58 and fig 11A-C paragraph 69).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to apply Carrel's teaching of a U-shaped drive chassis to the means of conveying syringe status and injection state directed by Helmer in order to couple the position of each limb, and therein couple the information conveyed by viewing the position of certain parts of each limb.
Regarding Claim 11:
Carrel in combination with Helmer discloses the autoinjector according to claim 10, wherein Carrel teaches a first limb of the U-shaped drive chassis is the dispensing limb (fig 3a-c shaft 21 paragraph 58 fig 11a-c paragraph 69)
and a second limb of the U-shapes drive chassis is the trigger limb (fig 3a-c longitudinal tubular lodging 23 paragraph 58 fig 11a-c paragraph 69).
Regarding Claim 15:
Carrel in combination with Helmer discloses the autoinjector according to claim 11, wherein Carrel teaches the trigger limb, the drive chassis and the dispensing limb (shaft 21 bridge 22 longitudinal tubular lodging 23 form drive chassis) are formed in one piece from a same material (fig 3a-3c paragraph 58).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer as applied to claim 1 above, and further in view of US 10905826 B2, henceforth written as Chang.
Regarding Claim 13:
Helmer discloses the elements which the present claim is dependent on, as described above. However, Helmer fails to disclose:
the housing is a two-part housing comprising an inner body and an outer body,
and both the syringe window and the status indicator window are arranged in a part of the housing where the inner body and the outer body overlap.
Chang teaches the housing is a two-part housing comprising an inner body (fig 2-4 medicament delivery device 14 page 7 line 21-23) and an outer body (fig 2-4 first shell section 12 page 7 line 21-23)
and both the syringe window and the status indicator window are arranged in a part of the housing where the inner body and the outer body overlap (openings 22 windows 26 page 8 line 3-6).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to apply Chang's teaching of having an inner and outer body with corresponding windows on each body, such that each window overlaps when the bodies overlap, to the means of conveying syringe status and injection state directed by Helmer in order to permit a user to view and engage with the outer body of the autoinjector such that the medicament within autoinjector can be viewed by the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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