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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/22/2026 has been entered.
Status of the Claims
Claims 4, 9, 11, and 13 are cancelled. Claims 1, 5, 8, 10, 12, and 14-15 are currently amended. Claims 1-3, 5-8, 10, 12, and 14-16 are currently pending. Claims 1-3, 5-8, 10, 12, and 14-16 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/22/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC § 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 Therefore, the rejection has been withdrawn.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 Barrelle (US 20030212380 A1) or alternatively Bicknell et al (US 20150209525 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-8, 10, and 15-16 are rejected under 35 U.S.C. 103 as being obvious over Jansen et al (US 20020120239 A1; hereafter Jansen) in view of Gagnieux et al (US 20020156426 A1; hereafter Gagnieux) and further in view of Bicknell et al (US-20150209525-A1; hereafter Bicknell); alternatively over Jansen in view of Gagnieux and further in view of Barrelle (US 20030212380 A1; hereafter Barrelle); and further alternatively in view of either above combination and further in view of Brunel2 (US 5855839 A; hereafter Brunel2).
Regarding claim 1, Jansen discloses a safety device (shield system 14, [0034] The shield system 14 according to the invention includes a holder 26, a shield 28 coupled to the holder, and a spring 30. It also preferably includes a holder end fitting 32 which engages one end of the spring.; see fig. 1) for mounting onto a medical container (syringe 12, fig. 1, [0032]) provided with a flange (flange 24, fig. 1, [0033]) and an injection needle (needle 18, fig. 1, [0033]), the safety device comprising:
a tubular body (holder 26, fig. 1, [0035] holder comprises a cylindrical body 34, see fig. 1) extending along a longitudinal axis, the tubular body (26) being configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to receive the medical container (12) ([0036] syringe 12 is arranged in holder 26),
a needle cover (shield 28, fig. 1, [0045]) movable relative to said body between a retracted position (see fig. 3), and an extended position (see fig. 4) in which the needle cover (28) distally extends from the retracted position in order to shield the injection needle (18) after activation of the safety device (see fig. 4 which shows shield 28 shielding needle 18; see [0049] Once the stop members 48, 58 are disengaged… needle 18 is entirely and permanently covered by the shield, as shown in FIGS. 4 and 8),
a release element (spring 30, fig. 1, [0045]) (see 112f interpretation above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to move the needle cover (28) from the retracted position to the extended position after activation of the safety device ([0049] Once the stop members 48, 58 are disengaged, the spring 30 expands rapidly, causing the shield to slide axially with respect to the holder and syringe barrel.),
a retainer (end fitting 32, fig. 1, [0034]), the retainer being configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to transmit a user's activation force to the needle cover (28) once an injection operation is completed ([0048] Following removal of the needle 18 from the patient, the user applies a greater force to the plunger rod than that applied during injection. Such force causes axial displacement of the end fitting, the spring and the shield with respect to the holder.),
wherein the needle cover (28) comprises a distal abutment surface (distal surface of stop member 58, fig. 3, [0041]), said distal abutment surface abutting against a proximal abutment surface (proximal face of stop member 48, fig. 3, [0041]) of a pair of diametrically opposite bumps (stop members 48, see two bumps in modified Fig-1 and Fig. 1.1 below) protruding from the body (holder 26) in the retracted position of the needle cover (see fig. 3 which shows engagement of distal and proximal abutment surfaces), each bump (48) being in the form of a rib circumferentially extending between a first end and an opposite second end (see each of the two bumps 48 below have a first end and an opposite second end),
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wherein an end of the body (holder 26) includes two diametrically opposite axial slots (openings 46A and 46B, fig. 3 and Modified Fig. 1.2 above, [0037] One or more openings, such as openings 46A, 46B, are formed in the holder body. These openings are in opposing relation.), each axial slot extending between ends of bumps (see Fig. 1-2 above Fig. 1 and Fig. 1.1 below), and
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wherein each bump (48) extends in a circumferential direction (see circumferential extension of bumps 48 noted by the black arc and the light grey arc in Jansen Modified Fig-1 above) according to a central angle (see Jansen Modified Fig-1 above, central angle is formed between the two arrows; ALTERNATIVELY see Jansen Modified Fig-1.1 above, which notes a different interpretation of the central angle).
In either the interpretation of Jansen Modified Fig-1 or Fig-1.1, Jansen is silent to the central angle being “between 22.5° - 45°”.
However, Jansen [0038] notes that “stop member 48… is interrupted by the openings 46A, 46B”, and [0037] notes that “sizes of the openings” (46A, 46B) “are selected based upon the amount of flexibility desired in the holder body”. Modifying the sizes of the openings, such as the width of the openings, would alter the circumferential length of the bump/step member 48. Therefore, a person of ordinary skill in the art would consider the circumferential length of the bump comprising a central angle to be a result effective variable that is optimized through routine experimentation of changing/modifying the size of the first and second axial slot to obtain the circumferential length of the bump such that it comprises a central angle “between 22.5°- 45°”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the central angle forming the circumferential length of the bump disclosed in Jansen by modifying the size (such as the width) of each axial slot to obtain a central angle “between 22.5°- 45°” associated with a desired flexibility of the device defined by the slot size (see col 4 lines 45-56) as a matter of routine optimization 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). (See MPEP § 2144.05(II).)
Jansen as modified is silent to the distal abutment surface located on a distal portion of the needle cover and a locking ring proximally located with respect to the distal abutment surface of the needle cover, the bump protruding from a distal portion of the body, and the axial slots included in the distal end of the body instead of the proximal end.
Gagnieux, directed to a similar device, teaches a safety device (shield system 14, [0026] The shield system 14 according to the invention includes a tubular holder 26, a tubular shield 28 coupled to the holder, a coil spring 30 and an end fitting 32 which engages one end of the spring.; see fig. 1 and fig. 4) for mounting onto a medical container (syringe 12, fig. 1, [0025]) provided with a flange (flange 24, fig. 1, [0025]) and an injection needle (needle 18, fig. 1, [0025]), the safety device including:
wherein a needle cover (shield 28, fig. 1, [0031]) comprises a distal abutment surface (distal surface of stop member 58, fig. 2, [0031]) located on a distal portion of the needle cover (see fig. 2, [0031] stop member 58 is formed near the distal end of the shield 28) and a locking ring (collar 59, fig. 2, [0031] collar or rib 59 is formed integrally on the shield body 56 towards the proximal end, and defines another stop member 59) proximally located with respect to the distal abutment surface (distal surface of stop member 58) of the needle cover (see fig. 2), said distal abutment surface abutting against a proximal abutment surface (proximal face of stop member 48, fig. 2, [0037]) of a bump (stop member 48) protruding from the body (holder 26, fig. 1, [0027] The holder 26 is preferably comprised of an elongate, generally cylindrical tubular body 34) in the retracted position of the needle cover (see fig. 3 which shows engagement of distal and proximal abutment surfaces) ([0037] first stop member or collar 58 is received in the radial groove or stop member 48 in the holder).
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 device of Jansen to add a locking ring instead of the second detents, and rearrange the bump and distal abutment surface (and thus also the axial slots) to have the locations taught by Gagnieux, since Jansen and Gagnieux are directed to very similar mechanisms. One would have been motivated to make the modification because having the distal abutment surface on the distal end of the needle shield results in the stop member 58 being outside of the body 26 after actuation of the device (see Gagnieux fig. 4 and 7), thus providing another resistance point to resetting the device, better protecting against reuse. In this arrangement, the locking ring 59 must be present on the proximal end of the needle shield to maintain the needle shield’s connection with the body, and the axial slots must be relocated along with the bumps to the distal end of the device such that the entire mechanism is reversed together, as would have been obvious to a PHOSITA.
Jansen modified by Gagnieux teaches all limitations of the claim except for wherein the first axial slot extends from a distal end of the body instead of from a proximal end of the body.
Brunel2, in the art of disposable injection devices, teaches a safety device with a body (syringe body 101, see fig. 10, col. 10 ln. 10-13) comprising a first axial slot (one of the longitudinal slots 102, fig. 3, see col. 8 lines 56-59) extending from a distal end (see slot extending all the way through distal end/upward direction in fig. 10) of the body (101).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to place the first axial slot on the body disclosed in Jansen at the distal end of the body as taught by Brunel2 for the purpose of providing the distal end of the device with a desired radial flexibility (see Brunel2 figs. 9-11 which show insertion of body and flexibility provided by slots 102, col. 9 ln. 64-col. 10 ln. 27). One would have been motivated to make the modification because radial flexibility at the distal end of the body would aid in the assembly of the device and resiliency of the body.
Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a slot provided at a proximal end of a safety device as disclosed in Jansen) for another known element (a slot provided at a distal end of a safety device taught by Brunel) in the art to obtain the predictable result of providing a degree of flexibility to a chosen end of a safety device (see MPEP § 2143.I.B).
Jansen as modified by Gagnieux or Gagnieux and Brunel2 is silent to two pairs of diametrically opposite bumps and each axial slot extending between the second ends of two adjacent bumps of the two pairs of diametrically opposite bumps.
Bicknell, in the art of injection devices, teaches two pairs of diametrically opposite bumps ([0029] “The latching shell 42 has slots dividing its cylindrical surface into six arcuate resiliently deformable arms 44, each having an internally directed barb 46 short of the end thereof. The free ends of the resilient arms 44 are chamfered as shown at 48.”) and each axial slot (see annotated fig. 3 of Bicknell below) extending between the second ends (see circled end in annotated fig. 3 below; Note that the second end of each of the bumps is interpreted to be the end closest to the longitudinal plane including the central line of both of the noted axial slots.) of two adjacent bumps of the two pairs of diametrically opposite bumps (see fig. 3 below), and wherein each bump extends in a circumferential direction according to a central angle (note that each bump covers approximately 1/6 of the circumference, therefore the central angle must be less than 60 degrees).
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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 device of Jansen as modified to include two pairs of diametrically opposite bumps and each axial slot extending between the second ends of two adjacent bumps of the two pairs of diametrically opposite bumps, since Bicknell also deals with slots for a medical injection device part which lend the part flexibility and internally directed bumps which engage internal device components and guide/restrict relative movement ([0029-0031]). One would have been motivated to make the modification because separating each bump of Jansen to form two pairs of diametrically opposing bumps between which the axial slots are formed would decrease the amount of material connecting each slot to the other, thus the modification would help to increase the flexibility of the tubing of Jansen.
Alternatively, Jansen as modified by Gagnieux is silent to two pairs of diametrically opposite bumps and each axial slot extending between the second ends of two adjacent bumps of the two pairs of diametrically opposite bumps.
Barrelle, in the art of safety shields for injection devices, teaches two pairs of diametrically opposite bumps (ledges 42, [0044], see modified figs. 12 and 13 below) and each axial slot (axial grooves 40, [0044], figs. 12 and 13 below) extending between the second ends (circled ends of each bump 42 below, closest to the axis connecting the opposing axial slots, closest to the “middle” of fig. 13 below) of two adjacent bumps of the two pairs of diametrically opposite bumps (see figs. 12 and 13 below).
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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 device of Jansen as modified to include two pairs of diametrically opposite bumps and each axial slot extending between the second ends of two adjacent bumps of the two pairs of diametrically opposite bumps, since Barrelle also deals with slots for a medical injection device part (slots 40, [0049]; see also resiliently biased detents 48 in fig. 12 and [0053]) which lend the part flexibility and internally directed bumps (42, fig. 12 and 13) which engage internal device components and guide/restrict relative movement ([0048]). One would have been motivated to make the modification because separating each bump of Jansen to form two pairs of diametrically opposing bumps between which the axial slots are formed would decrease the amount of material connecting each slot to the other, thus the modification would help to increase the flexibility of the tubing of Jansen.
Regarding claim 2, Jansen as modified in any alternative discloses the safety device of claim 1, as described above.
Jansen is silent to wherein the central angle is equal to or greater than 35°.
However, Jansen [0038] notes that “stop member 48… is interrupted by the openings 46A, 46B”, and [0037] notes that “sizes of the openings” (46A, 46B) “are selected based upon the amount of flexibility desired in the holder body”. Modifying the sizes of the openings, such as the width of the openings, would alter the circumferential length of the bump/step member 48. Therefore, a person of ordinary skill in the art would consider the circumferential length of the bump comprising a central angle to be a result effective variable that is optimized through routine experimentation of changing/modifying the size of the first and second axial slot to obtain the circumferential length of the bump such that it comprises a central angle “equal to or greater than 35°”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the central angle forming the circumferential length of the bump disclosed in Jansen by modifying the size (such as the width) of each axial slot to obtain a central angle “equal to or greater than 35°” associated with a desired flexibility of the device defined by the slot size (see col 4 lines 45-56) as a matter of routine optimization 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). (See MPEP § 2144.05(II).)
Regarding claim 3, Jansen as modified in any alternative discloses the safety device of claim 1, as described above.
Jansen is silent to wherein the central angle is equal to or lower than 35°.
However, Jansen [0038] notes that “stop member 48… is interrupted by the openings 46A, 46B”, and [0037] notes that “sizes of the openings” (46A, 46B) “are selected based upon the amount of flexibility desired in the holder body”. Modifying the sizes of the openings, such as the width of the openings, would alter the circumferential length of the bump/step member 48. Therefore, a person of ordinary skill in the art would consider the circumferential length of the bump comprising a central angle to be a result effective variable that is optimized through routine experimentation of changing/modifying the size of the first and second axial slot to obtain the circumferential length of the bump such that it comprises a central angle “equal to or lower than 35°”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the central angle forming the circumferential length of the bump disclosed in Jansen by modifying the size (such as the width) of each axial slot to obtain a central angle “equal to or lower than 35°” associated with a desired flexibility of the device defined by the slot size (see col 4 lines 45-56) as a matter of routine optimization 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). (See MPEP § 2144.05(II).)
Regarding claim 5, Jansen as modified in any alternative discloses the safety device of claim 1, as described above. Jansen further discloses wherein at least one of the proximal abutment surface (proximal face of stop member 48, fig. 3, [0041]) and the distal abutment surface (distal surface of stop member 58, fig. 3, [0041]) comprises a chamfer (“inclined surface” noted in [0041]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to ease passage of the needle cover (28, fig. 1) over the bumps (48, fig. 1) when the needle cover moves distally to the extended position ([0041] describes both stop members 48/58 having inclined surfaces/chamfers which engage with each other; [0048] “inclined surfaces of the stop members slide past each other” when the needle shield moves to cover the needle as described in [0049]).
Regarding claim 6, Jansen as modified in any alternative discloses the safety device of claim 1, as described above. Jansen further discloses wherein the distal abutment surface (distal surface of stop member 58, fig. 3, [0041]) is located on a reduced thickness portion (portion of needle cover 28 excluding the thickened portion formed by axially extending ribs 62, see fig. 4 and [0041]) of the needle cover (28, fig. 4, see Jansen Modified Fig-4 below).
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Regarding claim 7, Jansen as modified in any alternative discloses the safety device of claim 1, as described above. Jansen further discloses wherein the distal abutment surface (distal surface of stop member 58, fig. 3, [0041]) of the needle cover (28, fig. 1) is located on a radial protrusion (stop member 58, fig. 1, [0041] stop member 58 in the form of a radially outwardly extending collar is formed on the body 56 of the shield 28) of the needle cover (28), and the radial protrusion (58) has reinforcing means (see 112f interpretation above) (see [0041], radial protrusion/stop member 58 comprises an inclined surface and therefore reasonably comprises a ‘bulge’ as interpreted under 112f above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to reinforce a proximal side of this radial protrusion (58, fig. 4).
Regarding claim 8, Jansen as modified in any alternative discloses the safety device of claim 1, as described above. Jansen further discloses wherein at least one of the bumps (48, fig. 5) has a cantilevered portion (see Jansen Modified Fig-5 below, portion of bump farthest from the inner wall of the body is cantilevered).
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Regarding claim 10, Jansen as modified in any alternative discloses the safety device of claim 1, as described above, including wherein at least one of the bumps is circumferentially distant (Jansen: [0038] bump 48 ‘interrupted’ by slot 46A and see FIG-1—bump does not extend into slots 46A/B and therefore the slots must be ‘circumferentially distant’ or separated by a circumference) from a first axial slot (Jansen: opening 46A, fig. 3) of the two diametrically opposed axial slots (Jansen: 46A and 46B, see Jansen fig. 1.2 above) (see also modified figs. 12 and 13 of Barrelle or alternatively modified fig. 3 of Bicknell above which both show that the two bumps adjacent one slot are circumferentially distant to the other of the two slots).
Regarding claim 15, Jansen as modified in any alternative discloses the safety device of claim 1, as described above.
Jansen as modified teaches all limitations of the claim except for wherein the first axial slot extends from a distal end of the body instead of from a proximal end of the body, and the first axial slot having a predetermined length comprised between 1mm - 6 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the first axial slot so that it extended from a distal end of the body instead of from the proximal end of the body, 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 slots could still perform the function of supplying the tubular body with flexibility as noted in Jansen [0037].
Jansen [0037] notes that “sizes of the openings” (46A, 46B) “are selected based upon the amount of flexibility desired in the holder body”. Therefore, a person of ordinary skill in the art would consider the size (such as the length) of the openings to be a result effective variable that is optimized through routine experimentation of changing/modifying the size of the first and second axial slot to obtain a “predetermined length comprised between 1mm - 6 mm”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the size (such as the width) of each axial slot to obtain a “predetermined length comprised between 1mm - 6 mm” associated with a desired flexibility of the device defined by the slot size (see col 4 lines 45-56) as a matter of routine optimization 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). (See MPEP § 2144.05(II).)
Regarding claim 16, Jansen as modified in any alternative discloses an injection device (Jansen: medical device 10, fig. 1, [0032]) comprising a medical container (Jansen: syringe 12, fig. 1, [0032]) having an injection needle (Jansen: needle 18, fig. 1, [0033]) and the safety device (Jansen: shield system 14, [0032]) of claim 1 (see 103 rejection of claim 1 above), said safety device being mounted onto said medical container (Jansen: see fig. 1 and fig. 2 which show mounting, note [0032] “The device comprises a prefillable syringe 12 and a shield system 14 coupled to the syringe.”, [0034] describes components of shield system seen in fig. 1).
Claim(s) 8 is alternatively rejected under 35 U.S.C. 103 as being obvious over Jansen as modified in any alternative applied to claim 1 above, and further in view of Brunel (US 6186980 B1; hereafter Brunel).
Alternatively, regarding claim 8, Jansen as modified in any alternative discloses the safety device of claim 1, as described above.
Jansen as modified in any alternative is silent to wherein the bump has a cantilevered portion.
Brunel, in the art of single-use devices for injection, teaches wherein a bump (tabs 21 and transverse hook 22, see figs. 3 and 4, see col. 6 ln. 11-15) has a cantilevered portion (see col. 6 ln. 16-20, transverse hook 22 projects inside read body 9 and includes oblique front surface 22b which forms a ramp, note that the tabs 21 are deformable).
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 bump of Jansen to have a cantilevered portion as taught by Brunel since both references deal with syringes for drug delivery. One would have been motivated to make the modification because, as described by Brunel col. 6 ln. 16-20, the anti-return rear surface 22a opposite the ramp 22b on the cantilevered portion allows passage of the bump 21/22 only in one direction (see col. 8 ln. 51-57, after passing the ramp 22b, the ribs 28 are locked on the other side of ribs 22). This thus helps to better prevent syringe re-use.
Claim(s) 12 and 14 are rejected under 35 U.S.C. 103 as being obvious over Jansen as modified in any alternative and as applied to claim 1 above, and further in view of Suzuki (US 20100042047 A1).
Regarding claim 12, Jansen as modified in either noted alternative discloses the safety device of claim 1, as described above.
Jansen as modified is silent to wherein at least one of the bumps of the body has a decreasing height from said second end to said first end.
Suzuki, in the art of injection pens, teaches wherein at least one of the bumps (hook-like part 334, fig. 30, [0209-0210]) of the body (ring 33, fig. 30 and 31, [0208] ring 33 is a substantially cylindrical ring) has a decreasing height from said second end (end labeled 334p in fig. 31 below) to said first end (end labeled 334t in fig. 31 below) ([0210] “A second hook-like part 334B is a hook-like part including a part 334p in which the projection height toward the inner periphery side is substantially constant in the circumferential direction and an inclined part 334t in which the projection height gradually decreases in the circumferential direction from the part 334p as shown in the B-B sectional view in FIG. 31.”).
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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 bumps of Jansen as modified to include the decrease of inner height from the second end to the first end, as taught by Suzuki, since both references deal with injectors having inwardly projecting features meant to guide/limit relative movement of concentric components. One would have been motivated to make the modification because having a greater height nearer the axial slot would ensure that the deflection pressure on the body is greatest where the body is most flexible, directly adjacent to the axial ribs. Furthermore, the relative decrease of the bump height toward the first end of the bumps reduces the amount of material pushing on the portions of material farthest from the axial slots, making it less likely that the component will crack and also reducing the amount of material linking the opposing axial slots together, better facilitating flexibility of the body. Additionally, the decreasing height allows the bump to function with less material required, reducing the material cost of producing the device.
This modification represents a change in size/shape. Changing the height of the bump along the length of the bump would further have been obvious to one of ordinary skill in the art since this would change the size of the abutment surface of the bump that is engaged at any one time, thus altering the amount of friction provided by the abutment. Therefore, a person of ordinary skill in the art would consider the height along the bump to be a result effective variable that is optimized through routine experimentation of changing/modifying the shape of the bump such that the bump has a decreasing height from said second end to said first end. Note that is 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). (See MPEP § 2144.05(II).)
Regarding claim 14, Jansen as modified in any alternative discloses the safety device of claim 1, as described above.
Jansen as modified is silent to wherein the proximal abutment surface of at least one of the bumps (hook-like part 334, fig. 30, [0209-0210]) has a ramp portion, said ramp portion having a decreasing slope towards the first end of the at least one bump.
Suzuki, in the art of injection pens, teaches wherein the proximal abutment surface of at least one of the bumps has a ramp portion (inner projection profile of the bump, shown in figs. 30 and 31 above, noted by 334p and 334t), said ramp portion having a decreasing slope towards the first end (end labeled 334t in fig. 31 above) of the at least one bump ([0210] “A second hook-like part 334B is a hook-like part including a part 334p in which the projection height toward the inner periphery side is substantially constant in the circumferential direction and an inclined part 334t in which the projection height gradually decreases in the circumferential direction from the part 334p as shown in the B-B sectional view in FIG. 31.”).
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 bumps of Jansen as modified to include the ramp portion with a decrease of inner height from the second end to the first end, as taught by Suzuki, since both references deal with injectors having inwardly projecting features meant to guide/limit relative movement of concentric components. One would have been motivated to make the modification because having a greater height nearer the axial slot would ensure that the deflection pressure on the body is greatest where the body is most flexible, directly adjacent to the axial ribs. Furthermore, the relative decrease of the bump height toward the first end of the bumps reduces the amount of material pushing on the portions of material farthest from the axial slots, making it less likely that the component will crack and also reducing the amount of material linking the opposing axial slots together, better facilitating flexibility of the body. Additionally, the decreasing height allows the bump to function with less material required, reducing the material cost of producing the device.
This modification represents a change in size/shape. Changing the height of the bump along the length of the bump would further have been obvious to one of ordinary skill in the art since this would change the size of the abutment surface of the bump that is engaged at any one time, thus altering the amount of friction provided by the abutment. Therefore, a person of ordinary skill in the art would consider the height along the bump to be a result effective variable that is optimized through routine experimentation of changing/modifying the shape of the bump such that the bump has a decreasing height from said second end to said first end. Note that is 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). (See MPEP § 2144.05(II).)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-5163918-A – injector with specifically shaped abutment surfaces including a variable height (figs. 14-16, for example)
US-9694140-B2 – injector with inwardly extending ribs 110a (multiple diametrically opposed sets) and an axial locking member 50a aligned with a notch 116a (two diametrically opposed) in a flange 64a, see for example fig. 9b
US-9649452-B2 – injector with a shield having diametrically opposed axial slots 94 and diametrically opposed inward protrusions 40, see fig. 11
US-5067945-A – ramped flanges 87 provide a gripping surface and circumferentially ramps flanges 28 engage with the flanges 87, see for example figs. 4-7
US-5019051-A - packaging cap 18 has a plurality of spaced inwardly projecting prongs 20 adapted to form a friction fit with the interior surface of the outer distal end of the sleeve 14, see figs. 1-2
Brunel US-6186980-B1 – protective cap 3 includes two diametrically opposed tabs 34 and 35 which have lateral claws 38 and 39, see figs. 9-10
Brunel2 US-5855839-A – injector body contains multiple partial annular ribs 113, see figs. 6-7
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/09/2026
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