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 Amendment
This office action is responsive to the amendment filed on 12/30/2025. As directed by the amendment: Claims 1-15 have been previously cancelled. Claims 16-19, 20, 23, 25, 27, 31-35 have been amended. Claim 36 is added.
Thus, claims 16-36 are pending in this application.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Non-final Office Action mailed on 10/30/2025.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the Non-final Office Action mailed on 10/30/2025.
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 16-36 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 inward towards a longitudinal axis of the medicament delivery device”.
Claims 16 and 31 requires the flash to extend radially inward, 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 17-30 and 31-36 are also rejected.
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.
Claim 36 is 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 36, the phrase "the medicament delivery device" renders the claim indefinite because it is unclear whether the claim is dependent on claim 16 or the claim 31.
Clarification is required.
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 16-21 and 29-30 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 (syringe arrangement 10, see fig 1) comprising: a first component (inner holder 20), and a second component (outer shield 30) arranged concentrically with the first component (see figs 1-2), wherein the second component (outer shield 30) is configured to move axially relative to the first component from a first position to a second position (para 0020, see fig 1-outer shield 30 is in retracted position and fig 23- outer shield 30 is in extended position), wherein one of the first component and the second component has a radially extending flash (frustoconical portion 190, see figs 5, 9 and 10), wherein the radially extending flash extends radially outward away from a longitudinal axis of the medicament delivery device (fig 10), wherein the other one of the first component and the second component has a chamfer (abutment surfaces 280 with side inclined walls 290, see fig 15A-B) aligned with and facing the flash when the second component is in the first position (see fig 2, abutment surfaces 280 and side walls 290 aligned with portion 190), and wherein one of the chamfer (wall 290) and the flash (portion 190) is configured to contact and subsequently pass the other one of the chamfer and the flash when the second component (outer shield 30) is moved from the first position (retracted position, figs 1-4) towards the second position (extended position, see figs 21-23) to thereby facilitate movement of the second component (para 0099).
Regarding claim 17, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the medicament delivery device (device 10) has a proximal end (upper end of device 10) and a distal 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 figs 4 and 15A-B).
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 (abutment surfaces 280 and side walls 290) has a chamfer surface (inclined wall 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 (outer shield 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 (inner holder 20) is provided with the flash (frustoconical portion 190, see figs 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 (outer shield 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 (inner holder 20) and the second component (outer shield 30) are slidably interacting to each other (see figures).
Regarding claim 30, Shaw et al disclose the medicament delivery device as claimed in claim 16, wherein the first component and the second component are movable, but irremovable (see figs and para 0012, 0102, 0106).
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 and 31-35 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 (medicament container holder 14), a second component (guard 10) and a housing (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 (outer shield 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 (medicament container holder 14), a second component (guard 10) and a housing (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, when the second component (outer shield 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 forms a radially inner rear edge 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, when the second component (outer shield 30) is a delivery member cover (see fig 21-23) or a trigger button, wherein the first component (inner holder 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 (outer shield 30) is a delivery member cover (see figs 21-23), the medicament delivery device comprising a trigger button (trigger 50, para 0100), wherein the delivery member cover is configured to initially move from the second position (see figs 21-25) to the first position (see figs 26-29, see para 0106).
Shaw et al fail to teach 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 (medicament container holder 14), a delivery member cover (guard 10) and a trigger button (push button 42) wherein the medicament container holder (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 (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).
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 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, in the modified device of Shaw et al, 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 (see fig 1, device 10) comprising: a first sleeve (inner holder 20); and a second sleeve (outer shield 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 (frustoconical portion 190, see figs 5, 9 and 10), wherein the radially extending flash extends radially outward towards 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 (abutment surfaces 280 with side inclined walls 290, see fig 15A-B) aligned with and facing the flash when the second sleeve is in the first position (see fig 2, abutment surfaces 280 and side walls 290 aligned with portion 190), and wherein one of the chamfer and the flash contacts and subsequently moves axially past the other one of the chamfer and the flash when the second moves from the first position (see figs 1-4) towards the second position (see figs 21-25, para 0099).
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 (medicament container holder 14), a second sleeve (guard 10) and a housing (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 32, Shaw et al in view of Holmqvist disclose the medicament delivery device of claim 31, wherein the chamfer (wall 290) is on the second sleeve (fig 15A-B) and has a chamfer surface 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, wherein the flash (portion 190) is on the first sleeve 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 said delivery device, wherein 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.
However, Holmqvist discloses a medicament delivery device (see fig 1) , comprising a first sleeve (medicament container holder 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, in the modified device of Shaw et al, 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).
Claims 28 and 36 are 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 said medicament delivery device, wherein the flash extends radially at most 0.1 mm.
Shaw et al disclose said medicament delivery device, wherein the flash (portion 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]).
Regarding claim 28, Shaw et al teach fail to expressly teach the medicament delivery device, 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 (portion 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.
Response to Arguments
Applicant's arguments filed on 12/30/2025 have been fully considered but they are not persuasive.
Applicant submits that Shaw fails to explicitly disclose or suggest "wherein one of the first component and the second component has a radially extending flash, wherein the radially extending flash extends radially inward towards a longitudinal axis of the medicament delivery device", as recited in claim 16, examiner respectfully disagrees.
Claims 16 and 31 requires the flash to extend radially inward, 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 and Shaw et al disclose frustoconical portion 190 extends radially outward away from a longitudinal axis of the medicament delivery device.
The rejections of claims 16-35 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783