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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2026 has been entered.
Status of the Claims
Claims 26 and 30-32 are cancelled. Claims 18, 29, 35, and 37 are currently amended. Claims 18-25, 27-29, and 33-38 are currently pending. Claims 18-25, 27-29, and 33-38 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claim(s) 18-25, 27-29, and 33-38, as currently amended, under 35 USC § 102 or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an the combination of Willoughby et al (GB-2570319-A) and Giambattista et al (US 20160082197 A1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 18-19, 23-25, 28-29, and 33-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willoughby et al (GB-2570319-A; hereafter Willoughby) in view of Giambattista et al (US 20160082197 A1; hereafter Giambattista). Examiner notes that Willoughby was included in Applicant’s IDS and references are made to the foreign document of Willoughby included with a prior Office Action.
Regarding claim 18, Willoughby discloses a locking mechanism for preventing axial movement of a medicament delivery member cover in a medicament delivery device, the locking mechanism comprising:
a cap (second casing part 16, fig. 2, pg. 5 ln. 28-34) with a longitudinal axis (see fig. 2 which shows a longitudinal axis along the line of the medicament delivery device);
a locking ring (locking member 36, fig. 3) having an annular shape (see fig. 3; pg. 6 ln. 28-33 annular body portion 38 is part of locking member 36) and being rotatably positioned within an interior of the cap (see locking ring 36 in fig. 3 having no surface extending out past the end of protrusions 54, note pg. 9 ln. 33-pg. 10 ln. 3; see 4a-6b which show no structures that would prevent the cap 16 and locking ring 36 from relative rotation);
the medicament delivery member cover (sleeve 24, fig. 2) rotatably positioned (pg. 2 ln. 20-26, locking member may engage with a continuous groove in any orientation; Examiner notes that since the locking member may engage with the groove in any orientation, it is rotatably positioned because it could be rotated in the groove.) within an interior of the locking ring (36) (see fig. 4a which shows cooperation between medicament delivery member cover 24 and locking ring 36);
a first connection between the cap (16) and the locking ring (36), where the first connection comprises a first slot (slot formed by radially inwardly extending region 60, see annotated fig. 4b below) and a first protrusion (radially outward protrusions 54, fig. 3, fig. 5b) in the first slot (pg. 9 ln. 30-pg. 10 ln. 3, protrusion 54 engages with radially extending inward region 60), where the first slot is in one of the locking ring and the cap and the first protrusion is attached to the other of the locking ring and the cap (see fig. 4b); and
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a second connection between the locking ring (36) and the medicament delivery member cover (24), where the second connection comprises a second slot (groove 46, fig. 4b) and a second protrusion (radially inward protrusions 42, fig. 4a) arranged in the second slot (see fig. 4a) (pg. 7 ln. 25-33, engagement of the locking member 36 with the outer surface 30 is achieved by the radially inward protrusions 42 being receivable within a groove 46 of the outer surface 30), where the second slot is in one of the locking ring and the medicament delivery member cover (see fig. 4a), and the second protrusion is attached to the other of the locking ring and the medicament delivery member cover (see fig. 4a),
Willoughby is silent to wherein at least one of the first slot and the second slot comprises a cam surface inclined relative to the longitudinal axis, such that axial movement of the cap forces the locking ring to rotate via the respective protrusion sliding along the cam surface.
Giambattista, directed to a medicament delivery device, teaches wherein at least one of the first slot and the second slot comprises a cam surface inclined relative to the longitudinal axis (hole of camming connection 232,233 shown in fig. 11, [0065] a cam nut 226 is engaged with the transfer ring 216 through a camming connection 232, 233; see fig. 11), such that rotational movement of the cap forces the locking ring to move axially via the respective protrusion sliding along the cam surface ([0065] The camming connection 232, 233 between the transfer ring and the rotationally fixed cam nut 226 causes the transfer ring 216 to translate in the proximally direction 246 (see FIG. 12) as it is being rotated by the locking shell 205.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the first slot of Willoughby to be a helical/slanted cam as taught and shown by Giambattista because the helical/slanted cam would provide a more secure connection with more predictable movement than the flexible connection between the cap and the locking ring disclosed by Willoughby, which is flexible as shown in Willoughby fig. 4a-6b. This modification is desirable because the flexing arrangement of Willoughby may be more prone to breaking since the material bends during use.
Examiner notes that since relative rotation between the two components joined by the inclined cam surface and protrusion causes relative axial movement (see Giambattista [0065]), Willoughby modified by Giambattista thus further discloses, such that axial movement of the cap (see Willoughby figs. 4a-b vs. figs. 5a-6b) forces the locking ring (Willoughby: locking member 36; Giambattista: transfer ring 216) to rotate via the respective protrusion (Giambattista: 232, fig. 11) sliding along the cam surface (Giambattista: 233, fig. 11).
Regarding claim 19, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above.
Willoughby modified by Giambattista is silent to the first protrusion being attached to the cap, and projecting radially inward toward a longitudinal axis of the cap. Willoughby, as applied above, does disclose wherein the first protrusion (54, fig. 4b) is attached to the locking member (36, fig. 4b), and the first protrusion (54) projects radially outward from an exterior portion of the locking member (36) away from a longitudinal axis of the locking member (see fig. 4b).
Willoughby modified by Giambattista discloses the locking mechanism of claim 19 except for the first protrusion being attached to the cap instead of the locking member, projecting inward from an interior instead of outward from an exterior, and projecting toward instead of away from a longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to switch the first slot and first protrusion such that the first protrusion was arranged on the inside of the cap instead of the outside of the locking member, thus arriving at all of the claim limitations due to the reversed arrangement, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of selectively locking the two parts together with the described arrangement.
Regarding claim 23, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including wherein the locking ring (locking member 36, fig. 3) is configured to rotate relative to the cap (second casing part 16, fig. 2) from a locked position (first axial position shown in fig. 4a/4b; pg. 8 ln. 9-25, in the first axial position locking member 36 cannot disengage from the outer surface 30) to an unlocked position (second axial position, shown in fig. 5a-6b; pg. 9 ln. 16-23, in the second axial position, the locking member 36 may be disengageable from the outer surface 30.) when the cap (16) is moved axially relative to the medicament delivery member cover (sleeve 24, figs. 4a/b show first axial position of cap 16 and medicament delivery member cover 24; figs. 5a/b and 6a/b show second axial position after relative axial movement) (Note camming connection 232,233 of Giambattista connects the cap and locking ring as described in the 103 rejection of claim 18 above, thus causing the locking ring to rotate as well as move axially relative to the cap during axially movement of the cap relative to the medicament delivery member cover.).
Regarding claim 24, Willoughby modified by Giambattista discloses the locking mechanism of claim 23, as described above, including wherein when the locking ring (Willoughby: 36, fig. 4a) is in the locked position (Willoughby: first axial position shown in fig. 4a, see pg. 7 ln. 19-24 which describes the first axial position) the medicament delivery member cover (Willoughby: 24, fig. 4a) cannot move axially relative to an outer housing (Willoughby: first casing part 14) of the medicament delivery device (Willoughby: pg. 7 ln. 19-24 in the first axial position, the locking member 36 is engageable with the outer surface 30 of the sleeve 24 to inhibit an axial movement of the sleeve 24 relative to the first casing part 14).
Regarding claim 25, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including wherein the first slot comprises a helical cam (Giambattista: hole of camming connection 232,233 shown in fig. 11).
Regarding claim 28, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including wherein the locking ring (Willoughby: locking member 36, fig. 3) extends from a proximal end to a distal end relative to the longitudinal axis (see fig. 2 and 3 which show that the locking ring extends from a proximal end to a distal end).
Willoughby modified by Giambattista discloses the locking mechanism of claim 28 except for wherein the second slot is spaced apart from the proximal end and from the distal end in a direction relative to the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the second slot spaced apart from either end of the locking ring, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of selectively locking the two parts together with the described arrangement.
Regarding claim 29, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including where the first protrusion (Giambattista: protrusion of camming connection 232,233 shown in fig. 11) comprises a cam follower (Giambattista: note [0065] which describes the camming connection and fig. 11 which shows a closed cam so the protrusion is a cam follower always engaged with the cam surface) that is always slidably engaged (Giambattista: fig. 11 shows the progress of the protrusion 232 of the camming connection 232,233 ride along the wall of slot 233 of the camming connection 232,233) with the cam surface on the first slot (see side of slot of camming connection 232,233 shown in fig. 11).
Regarding claim 33, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including wherein the first slot and the second slot both extend a same distance around the longitudinal axis (Examiner notes that both the first slot and second slot extend some distance around the longitudinal axis, and both extend the distance of the shorter slot around the longitudinal axis, if one of the slots does extend farther then they both still extend a same distance related to that of the one which extends a smaller way around the longitudinal axis.).
Regarding claim 34, Willoughby modified by Giambattista discloses a medicament delivery device (Willoughby: medicament delivery device 10, fig. 1, pg. 5 ln. 27-35) comprising the locking mechanism of claim 18 (see 103 rejection of claim 18 above).
Regarding claim 35, Willoughby discloses a locking mechanism for preventing axial movement of a medicament delivery member cover in a medicament delivery device, the locking mechanism comprising:
a cap (second casing part 16, fig. 2) with a longitudinal axis (see fig. 2 which shows a longitudinal axis along the line of the medicament delivery device);
a locking ring (locking member 36, fig. 3) positioned within an interior of the cap, having an annular shape (see fig. 3; pg. 6 ln. 28-33 annular body portion 38 is part of locking member 36) and being rotatable relative to the cap (see locking ring 36 in fig. 3 having no surface extending out past the end of protrusions 54, note pg. 9 ln. 33-pg. 10 ln. 3; see 4a-6b which show no structures that would prevent the cap 16 and locking ring 36 from relative rotation);
the medicament delivery member cover (sleeve 24, fig. 2) rotatably positioned (pg. 2 ln. 20-26, locking member may engage with a continuous groove in any orientation; Examiner notes that since the locking member may engage with the groove in any orientation, it is rotatably positioned because it could be rotated in the groove.) within an interior of the locking ring (36) (see fig. 4a which shows cooperation between medicament delivery member cover 24 and locking ring 36);
a first connection between the cap (16) and the locking ring (36), where the first connection comprising a first slot (slot formed by radially inwardly extending region 60, see annotated fig. 4b above) and a first protrusion (radially outward protrusions 54, fig. 3, fig. 5b) in the first slot (pg. 9 ln. 30-pg. 10 ln. 3, protrusion 54 engages with radially extending inward region 60), where the first slot is in one of the locking ring and the cap and the first protrusion is attached to the other of the locking ring and the cap (see fig. 4b); and
a second connection between the locking ring (36) and the medicament delivery member cover (24), where the second connection comprising a second slot (groove 46, fig. 4b) and a second protrusion (radially inward protrusions 42, fig. 4a) arranged in the second slot (see fig. 4a) (pg. 7 ln. 25-33, engagement of the locking member 36 with the outer surface 30 is achieved by the radially inward protrusions 42 being receivable within a groove 46 of the outer surface 30), where the second slot is in one of the locking ring and the medicament delivery member cover (see fig. 4a), and the second protrusion is attached to the other of the locking ring and the medicament delivery member cover (see fig. 4a).
Willoughby further discloses wherein the locking ring (locking member 36, fig. 3) is configured to move relative to the cap (second casing part 16, fig. 2) from a locked position (first axial position shown in fig. 4a/4b; pg. 8 ln. 9-25, in the first axial position locking member 36 cannot disengage from the outer surface 30) to an unlocked position (second axial position, shown in fig. 5a-6b; pg. 9 ln. 16-23, in the second axial position, the locking member 36 may be disengageable from the outer surface 30.) when the cap (16) is moved axially relative to the medicament delivery member cover (sleeve 24, figs. 4a/b show first axial position of cap 16 and medicament delivery member cover 24; figs. 5a/b and 6a/b show second axial position after relative axial movement).
Willoughby is silent to wherein at least one of the first slot and the second slot comprises a cam surface inclined relative to the longitudinal axis, such that axial movement of the cap forces the locking ring to rotate via the respective protrusion sliding along the cam surface.
Giambattista, directed to a medicament delivery device, teaches wherein at least one of the first slot and the second slot comprises a cam surface inclined relative to the longitudinal axis (hole of camming connection 232,233 shown in fig. 11, [0065] a cam nut 226 is engaged with the transfer ring 216 through a camming connection 232, 233; see fig. 11), such that rotational movement of the cap forces the locking ring to move axially via the respective protrusion sliding along the cam surface ([0065] The camming connection 232, 233 between the transfer ring and the rotationally fixed cam nut 226 causes the transfer ring 216 to translate in the proximally direction 246 (see FIG. 12) as it is being rotated by the locking shell 205.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the first slot of Willoughby to be a helical/slanted cam as taught and shown by Giambattista because the helical/slanted cam would provide a more secure connection with more predictable movement than the flexible connection between the cap and the locking ring disclosed by Willoughby, which is flexible as shown in Willoughby fig. 4a-6b. This modification is desirable because the flexing arrangement of Willoughby may be more prone to breaking since the material bends during use.
Examiner notes that since relative rotation between the two components joined by the inclined cam surface and protrusion causes relative axial movement (see Giambattista [0065]), Willoughby modified by Giambattista thus further discloses, such that axial movement of the cap (see Willoughby figs. 4a-b vs. figs. 5a-6b) forces the locking ring (Willoughby: locking member 36; Giambattista: transfer ring 216) to rotate via the respective protrusion (Giambattista: 232, fig. 11) sliding along the cam surface (Giambattista: 233, fig. 11).
Regarding claim 36, Willoughby modified by Giambattista discloses the locking mechanism of claim 35, as described above. Willoughby further discloses wherein when the locking ring (36, fig. 4a) is in the locked position (first axial position shown in fig. 4a, see pg. 7 ln. 19-24 which describes the first axial position) the medicament delivery member cover (24, fig. 4a) cannot move axially relative to an outer housing (first casing part 14) of the medicament delivery device (pg. 7 ln. 19-24 in the first axial position, the locking member 36 is engageable with the outer surface 30 of the sleeve 24 to inhibit an axial movement of the sleeve 24 relative to the first casing part 14).
Regarding claim 37, Willoughby modified by Giambattista discloses the locking mechanism of claim 36, as described above, including wherein the first slot comprises a helical cam (Giambattista: hole of camming connection 232,233 shown in fig. 11).
Regarding claim 38, Willoughby modified by Giambattista discloses the locking mechanism of claim 35, as described above, including wherein the locking ring (Willoughby: 36, fig. 4a) is further configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to rotate relative to the medicament delivery member cover (Willoughby: 24, fig. 4a) from the locked position to the unlocked position (Giambattista: see camming connection 232,233 movement in figs. 11 and 12) when the cap (Willoughby: 16, fig. 4a) is moved axially relative to the medicament delivery member cover (Willoughby: sleeve 24, figs. 4a/b show first axial position of cap 16 and medicament delivery member cover 24; figs. 5a/b and 6a/b show second axial position after relative axial movement) (Note camming connection 232,233 of Giambattista connects the cap and locking ring as described in the 103 rejection of claim 18 above, thus causing the locking ring to rotate as well as move axially relative to the cap during axially movement of the cap relative to the medicament delivery member cover.).
Claim(s) 20-22 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willoughby in view of Giambattista and further in view of Ferguson et al (US 20150032065 A1; hereafter Ferguson).
Regarding claim 20, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including the second slot (Willoughby: groove 46, fig. 4b).
Willoughby modified by Giambattista is silent to the slot having an open end.
Ferguson, directed to a releasably engageable medical needle shield apparatus ([0166]), teaches wherein a slot (retention element 1818, [0167], fig. 35) has an open end (see fig. 35 which shows open end of slot 1818, see also figs. 37-39 which show the movement of a protrusion 1802 within the slot and out of the open end).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the second slot of Willoughby modified by Giambattista to have an open end as taught by Ferguson since both deal with locking/unlocking mechanisms for safety features of injection devices. One would have been motivated to make the modification because the open end would allow for assembly or separation of the medicament delivery member cover and the locking ring without needing a portion of the locking ring to flex. This is desirable because the flexing arrangement of Willoughby may be more prone to breaking since the material bends during use.
Willoughby modified by Giambattista and Ferguson discloses the locking mechanism of claim 20 except for wherein the second slot is in the locking ring and the second slot is located at a distal end of the locking ring. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the second slot at a distal end of the locking ring instead of in the medicament delivery member cover, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of selectively locking the two parts together with the described arrangement.
Regarding claim 21, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including wherein the second slot (Willoughby: groove 46, fig. 4b) is in the medicament delivery member cover (Willoughby: sleeve 24, fig. 4b), and the second slot is located at a proximal end of the medicament delivery member cover (Willoughby: see fig. 4b which shows that groove 46 is on the proximal portion of the medicament delivery member cover 24).
Willoughby modified by Giambattista is silent to the slot having an open end.
Ferguson, directed to a releasably engageable medical needle shield apparatus ([0166]), teaches wherein a slot (retention element 1818, [0167], fig. 35) has an open end (see fig. 35 which shows open end of slot 1818, see also figs. 37-39 which show the movement of a protrusion 1802 within the slot and out of the open end).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the second slot of Willoughby to have an open end as taught by Ferguson since both deal with locking/unlocking mechanisms for safety features of injection devices. One would have been motivated to make the modification because the open end would allow for assembly or separation of the medicament delivery member cover and the locking ring without needing a portion of the locking ring to flex. This is desirable because the flexing arrangement of Willoughby may be more prone to breaking since the material bends during use.
Regarding claim 22, Willoughby modified by Giambattista and Ferguson discloses the locking mechanism of claim 20, as described above, including wherein the second slot (Ferguson: retention element 1818, [0167], fig. 35) extends from the open end to a closed end (Ferguson: see figs. 37-39 which show the movement of a protrusion 1802 within the slot and out of the open end), and wherein the second protrusion (Ferguson: safety shield retention element 1802, figs. 37-39, [0166]) is in the second slot (1818) at the closed end (Ferguson: see fig. 35 which shows protrusion 1802 at the closed end in the second slot 1818).
Regarding claim 27, Willoughby modified by Giambattista discloses the locking mechanism of claim 18, as described above, including the second slot (Willoughby: groove 46, fig. 4b).
Willoughby modified by Giambattista is silent to the slot being an L-shaped cut-out.
Ferguson, directed to a releasably engageable medical needle shield apparatus ([0166]), teaches wherein a slot (retention element 1818, [0167], fig. 35) is an L-shaped cut-out (see fig. 35 which shows retention element/protrusion 1802 in slot 1818, see also figs. 37-39 which show the movement of a protrusion 1802 within the L-shaped cut-out).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the second slot of Willoughby to be an L-shaped cut-out as taught by Ferguson since both references deal with locking/unlocking mechanisms for safety features of injection devices. One would have been motivated to make the modification because the open end of the L-shape would allow for assembly or separation of the medicament delivery member cover and the locking ring without needing a portion of the locking ring to flex. This is desirable because the flexing arrangement of Willoughby may be more prone to breaking since the material bends during use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McKinnon et al (US 20160136412 A1) - helical camming connection in a tubing connection, fig. 13
Beissel et al (US 20160022962 A1) - helical camming connection with one open end and one closed end, fig. 1a
Spence et al (US 20080228267 A1) - helical camming connection, closed at both ends, fig. 16c
Cai et al (US 5632729 A) - camming connection with a helical section 128 and straight axial section 126, fig. 3
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 04/03/2026