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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 05/12/2026. As directed by the amendment: Claims 1-15 have been previously cancelled. Claims 16, 31 and 36 have been amended. Claim 17 is cancelled and claims 37-40 are added.
Thus, claims 16, 18-40 are pending in this application.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the final Office Action mailed on 03/23/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16, 18-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 16 and 31 recite the limitations “wherein the radially extending flash extends radially outward towards a longitudinal axis of the medicament delivery device”.
Claims 16 and 31 require the flash to extend radially outward towards a longitudinal axis, however, the flash as described in para 0064 and figures 2 and 3 extends radially outward away from a longitudinal axis of the medicament delivery device.
For the purpose of examination, examiner is interpreting the limitations as “wherein the radially extending flash extends radially outward away from a longitudinal axis of the medicament delivery device”.
By virtue of dependency, claims 18-30 and 32-40 are also rejected.
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.
Claims 16, 18-21, 29, 30 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaw et al (US 20070191783 A1).
Regarding claim 16, Shaw et al disclose a medicament delivery device (10) comprising: a proximal end located closest to a dose delivery site (lower portion of device 10 where needle 430 is attached); a distal end located furthest away from the dose delivery site (upper portion of device 10 opposite to said proximal portion, see fig 1); a first component (20), and a second component (30) arranged concentrically with the first component (figs 1-2), wherein the second component (30) is configured to move axially relative to the first component from a first position (figs 1-4, 30 is retracted, see abstract) a to a second position (figs 21-24, 30 is extended), wherein one of the first component and the second component has a radially extending flash (190), wherein the radially extending flash (190) extends radially outward away a longitudinal axis of the medicament delivery device (fig 9 and para 0098), wherein the other one of the first component and the second component has a chamfer (290) aligned with and facing the flash (190) when the second component is in the first position (fig 2), wherein the chamfer (290) tapers in a direction from the distal end towards the proximal end (see annotated figure below), and wherein one of the chamfer (290) and the flash (190) is configured to contact and subsequently pass the other one of the chamfer and the flash when the second component is moved from the first position (fig 2) towards the second position (fig 21) to thereby facilitate movement of the second component (inclined wall 290 contacts surface 200 of 190 to cover inclines surface 210 of 190, see para 0098-99).
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Regarding claim 18, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the medicament delivery device has a longitudinal central axis (see figs 1-2) and wherein the chamfer (290) has a chamfer surface (inclined wall of 290) that faces the longitudinal central axis (see figs 15A-B).
Regarding claim 19, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the second component (30) is biased towards the second position (see figs 21-23 and para 0099 and 0106).
Regarding claim 20, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the first component (20) is provided with the flash (190, see fig 5) and the second component (outer shield 30) is arranged radially outside the first component (see figs 1-4).
Regarding claim 21, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the second component (30) is a delivery member cover (see figs 21-23, outer shield 30 cover needle 440) or a trigger button or a medicament container holder (para 0106- the outer shield 30 is caused to slide over inner holder 20, covering needle 430 and preventing any possible needle sticks).
Regarding claim 29, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the first component (20) and the second component (30) are slidably interacting to each other (see figures, para 0106).
Regarding claim 30, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the first component (20) and the second component (30) are movable, but irremovable (see figs and para 0012, 0102, 0106).
Regarding claim 39, Shaw et al disclose the medicament delivery device of claim 16, wherein the chamfer (290) is arranged to engage the flash (190) by sliding contact (fig 21, para 0099).
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.
Claims 22-27, 31-36 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al (US 20070191783 A1) in view of Holmqvist (US 20140018744 A1).
Regarding claim 22, Shaw et al disclose the limitations of claim 16 but fail to teach said medicament delivery device, comprising a housing.
However, Holmqvist discloses a medicament delivery device (see fig 1) , comprising a first component (14), a second component (10) and a housing (11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Shaw et al and incorporate the teachings of Holmqvist to have said medicament delivery device, comprising a housing. This would provide the benefit of having a protective enclosure for a device's internal components, designed to ensure safety, reliability, and performance (para 0057).
Regarding claim 23, Shaw et al disclose the limitations of claims 16 and 21, and further teach wherein when the second component (30) is a delivery member cover (see figs 21-23) or a trigger button, and wherein the first position is a retracted position (see figs 1-4) and the second position is an extended position (see figs 21-25).
Shaw et al fail to teach said medicament delivery device further comprising a housing, wherein the first component and the second component are arranged in the housing wherein in the first position the second component is retracted further into the housing than in the second position.
However, Holmqvist discloses a medicament delivery device (see fig 1) , comprising a first component (14), a second component (10) and a housing (11) wherein the first component and the second component are arranged in the housing wherein in the first position the second component is retracted further into the housing than in the second position (see fig 2 and para 0057-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Shaw et al and incorporate the teachings of Holmqvist to have said medicament delivery device, comprising a housing wherein the first component and the second component are arranged in the housing wherein in the first position the second component is retracted further into the housing than in the second position. This would provide the benefit of having a protective enclosure for a device's internal components such as the first component and the second component in which in the first position the second component is retracted further into the housing. This would ensure safety, reliability, performance and protection (para 0057).
Regarding claim 24, Shaw et al in view of Holmqvist disclose the medicament delivery device as claimed in claim 23,
Shaw et al further disclose when the second component (30) is a delivery member cover (see figs 21-23), wherein the second component comprises a radial window (see figs 15A-B, opening between wall 290 and arm 300), wherein the chamfer (290) forms a radially inner rear edge (280) of the radial window (see figs 14 and 20).
Regarding claim 25, Shaw et al in view of Holmqvist disclose the medicament delivery device as claimed in claim 23,
Shaw et al further disclose when the second component (30) is a delivery member cover (see fig 21-23) or a trigger button, wherein the first component (20) is a medicament container holder (para 0105, holder 20 holds medicament barrel 410, see fig 2).
Regarding claim 26, Shaw et al in view of Holmqvist disclose the limitations of claims 16, 21, 23 and 25 and further teach said medicament delivery device as claimed in claim 25, when the second component (30) is a delivery member cover (see figs 21-23), the medicament delivery device comprising a trigger button (460).
Shaw et al fail to teach herein the delivery member cover is configured to initially move from the second position to the first position, wherein the medicament container holder has a pivotable see-saw lever provided with a front see-saw arm and a rear see-saw arm, the rear see-saw arm being configured to block the trigger button from axial movement when the delivery member cover initially is in the second position, wherein the delivery member cover is configured to urge the rear see-saw arm radially inwards when the delivery member cover is moved from the second position towards the first position, enabling the trigger button to move forward axially to a depressed position.
However, Holmqvist discloses a medicament delivery device (see fig 1) , comprising a medicament container holder (4), a delivery member cover (10) and a trigger button (42), wherein the delivery member cover (10) is configured to initially move from the second position to the first position (para 0066), wherein the medicament container holder (14) has a pivotable see-saw lever (lever 16, para 0059, see fig 2) provided with a front see-saw arm (proximal end 19) and a rear see-saw arm (distal end 20 with ledge 22), the rear see-saw arm being configured to block the trigger button from axial movement when the delivery member cover initially is in the second position (para 0065), wherein the delivery member cover (10) is configured to urge the rear see-saw arm radially inwards when the delivery member cover is moved from the second position towards the first position, enabling the trigger button to move forward axially to a depressed position (para 0066-68).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Shaw et al and incorporate the teachings of Holmqvist to have the delivery member cover is configured to initially move from the second position to the first position and the medicament container holder has a pivotable see-saw lever provided with a front see-saw arm and a rear see-saw arm, the rear see-saw arm being configured to block the trigger button from axial movement when the delivery member cover initially is in the second position, wherein the delivery member cover is configured to urge the rear see-saw arm radially inwards when the delivery member cover is moved from the second position towards the first position, enabling the trigger button to move forward axially to a depressed position. This would provide the benefit of not using a safety clip but a locking mechanism than can be pivotally mounted in any member of the medicament delivery device and restricts movement of the trigger button until the delivery member cover is positioned in a distal position to ensure the trigger button can only be unlocked by pressing the proximal end of the delivery member cover against a dose delivery site (para 0013-14 and 0066).
Regarding claim 27, Shaw et al in view of Holmqvist disclose the medicament delivery device as claimed in claim 23,
Holmqvist discloses the flash (proximal end 19) is arranged on the front see-saw arm (see figs 1-2).
Regarding claim 31, Shaw et al disclose a medicament delivery device (10) comprising: a proximal end located closest to a dose delivery site (lower portion of device 10 where needle 430 is attached); a distal end located furthest away from the dose delivery site (upper portion of device 10 opposite to said proximal portion, see fig 1); a first sleeve (20); and a second sleeve (30) arranged concentrically and slidably with the first sleeve (see figs 1-4, para 0099) such that the first and second sleeves interact with each other when the second sleeve moves axially relative to the first sleeve from a first position (see figs 1-4) to a second position (see figs 21-25), wherein one of the first sleeve and the second sleeve has a radially extending flash (90, see figs 5, 9 and 10), wherein the radially extending flash extends radially outward away to a longitudinal axis of the medicament delivery device (fig 10), wherein the other one of the first sleeve and the second sleeve has a chamfer (290, see fig 15A-B) aligned with and facing the flash when the second sleeve is in the first position (see fig 2, side walls 290 aligned with portion 190), wherein the chamfer (290) tapers in a direction from the distal end towards the proximal end (see annotated figure above) and wherein one of the chamfer (290) and the flash (190) contacts and subsequently moves axially past the other one of the chamfer and the flash when the second sleeve moves from the first position (see figs 1-4) towards the second position (see figs 21-25, para 0099, inclined wall 290 contacts surface 200 of 190 to cover inclines surface 210 of 190).
Shaw et al fail to teach said medicament delivery device comprising: a housing having a longitudinal axis.
However, Holmqvist discloses a medicament delivery device (see fig 1) , comprising a first sleeve (14), a second sleeve (10) and a housing (11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Shaw et al and incorporate the teachings of Holmqvist to have said medicament delivery device, comprising a housing. This would provide the benefit of having a protective enclosure for a device's internal components sch as the first sleeve and second sleeve and designed to ensure safety, reliability, and performance (para 0057).
Regarding claim 32, Shaw et al in view of Holmqvist disclose the medicament delivery device of claim 31,
Shaw et al disclose wherein the chamfer (290) is on the second sleeve (fig 15A-B) and has a chamfer surface (surface wall of 290) that faces the longitudinal central axis (see figs 15A-B).
Regarding claim 33, Shaw et al in view of Holmqvist disclose the medicament delivery device of claim 31,
Shaw et al disclose wherein the flash (190) is on the first sleeve (20) and extends radially outward relative to the longitudinal axis (see figs 9 and 10).
Regarding claim 34, Shaw et al in view of Holmqvist disclose the limitations of claim 31, but fail to teach wherein first sleeve (20) further comprises a pivotable see-saw lever comprising a front see-saw arm and a rear see-saw arm, where the flash is arranged on the front see-saw arm.
However, Holmqvist discloses a medicament delivery device (see fig 1) , comprising a first sleeve (14), a second sleeve (guard 10) wherein first sleeve further comprises a pivotable see-saw lever (lever 16) comprising a front see-saw arm (proximal end 19) and a rear see-saw arm (distal end 20), where the flash (proximal end 19) is arranged on the front see-saw arm (see figs 1 and 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to cause the device of Shaw et al and incorporate the teachings of Holmqvist to have first sleeve further comprises a pivotable see-saw lever comprising a front see-saw arm and a rear see-saw arm, where the flash is arranged on the front see-saw arm. This would provide the benefit of not using a safety clip but a locking mechanism than can be pivotally mounted in any member of the medicament delivery device and restricts movement of the trigger button until the delivery member cover is positioned in a distal position to ensure the trigger button can only be unlocked by pressing the proximal end of the delivery member cover against a dose delivery site (para 0013-14 and 0066).
Regarding claim 35, Shaw et al in view of Holmqvist disclose the medicament delivery device of claim 33,
Holmqvist discloses said device further comprising a trigger button (push button 42), where the rear see-saw arm is configured to block the trigger button from axial movement when the delivery member cover initially is in the second position (para 0065), wherein the delivery member cover (guard 10) is configured to urge the rear see-saw arm radially inwards when the delivery member cover is moved from the second position towards the first position, enabling the trigger button to move forward axially to a depressed position (para 0066-68).
Regarding claim 36, Shaw et al in view of Holmqvist fail to expressly teach wherein the length of the flash is less than half of the length of the chamfer.
Shaw et al disclose said medicament delivery device, comprising a flash (190) and a chamfer (290).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Shaw et al by making the length of the flash is less than half of the length of the chamfer since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.
Regarding claim 40, Shaw et al in view of Holmqvist disclose the medicament delivery device of claim 31,
Shaw et al disclose wherein the chamfer (290) is arranged to engage the flash (190) by sliding contact (fig 21, para 0099).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al (US 20070191783 A1).
Regarding claim 28, Shaw et al disclose the limitations of claim 16 but fail to teach wherein the flash extends radially at most 0.1 mm.
Shaw et al disclose said medicament delivery device, wherein the flash (190) extends radially (see fig 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shaw et al to have the flash extends radially at most 0.1 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Shaw et al would not operate differently with the claimed dimension and since the flash extends radially, the device would function appropriately having the claimed dimension. Further, applicant places no criticality on the dimension claimed, indicating simply that the flash extends radially at most 0.1 mm (specification pp. [0040]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al (US 20070191783 A1) in view of Bostrom (US 20120184918 A1).
Regarding claim 37, Shaw et al disclose the limitations of claim 16 but fail to teach wherein the flash is semi-circular in shape.
Bostrom discloses a delivery device (10) comprising a first component (28) with a flash (70) and a second component (12) wherein the flash is semi-circular in shape (fig 2, edge of 70 is semicircular).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the flash of Shaw et al to be semi-circular in shape as taught by Bostrom as an alternative contact force between said flash and chamfer to provide rather low force requirements for said chamfer to slide into said flash (para 0048).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al (US 20070191783 A1) in view of Holmqvist (US 20140018744 A1) and further in view of Bostrom (US 20120184918 A1).
Regarding claim 38, Shaw et al in view of Holmqvist disclose the limitations of claim 31 but fail to teach wherein the flash is semi-circular in shape.
Bostrom discloses a delivery device (10) comprising a first component (28) with a flash (70) and a second component (12) wherein the flash is semi-circular in shape (fig 2, edge of 70 is semicircular).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the flash of Shaw et al to be semi-circular in shape as taught by Bostrom as an alternative contact force between said flash and chamfer to provide rather low force requirements for said chamfer to slide into said flash (para 0048).
Response to Arguments
The applicant’s arguments concerning the previous rejections under 35 U.S.C. § 112(a) and 112(b) (page 8 of Remarks) have been considered, but are moot due to the claim amendments.
Applicant's arguments filed on 05/12/2026 regarding 102 rejections have been fully considered but they are not persuasive.
Applicant submits that Shaw fails to explicitly disclose or suggest "a proximal end located closest to a dose delivery site; a distal end located furthest away from the dose delivery site;... wherein the other one of the first component and the second component has a chamfer aligned with and facing the flash when the second component is in the first position, wherein the chamfer tapers in a direction from the distal end towards the proximal end", examiner respectfully disagrees.
In response to the arguments, Shaw disclose a proximal end located closest to a dose delivery site; a distal end located furthest away from the dose delivery site (see rejections of claims 16 and 31 above). Shaw’s device has an end closest to an attached needle and an opposite end that is further away from the needle.
In regards to the arguments that the Examiner states that Shaw discloses “the medicament delivery device (device 10) has a proximal end (upper end of device 10) and a distal [sic] end (lower end of device 10), wherein the chamfer (inclined wall 290) tapers in a direction from the distal end towards the proximal end". See Office Action, p. 5”, applicant is reminded that the proximal end of a drug delivery device (such as an injector, catheter, or pump) refers to the end situated furthest from the patient's body/closest to the user's hand and the distal end refers to the end closest to the patient's body/contains the needle, nozzle, or opening where the medication is actually dispensed.
In response to applicant's argument that “the prior art fail to teach a proximal end located closest to a dose delivery site; a distal end located furthest away from the dose delivery site”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The rejections of claims 16, 18-40 are maintained.
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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