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 .
Status of the Claims
Claims 1-16 are currently pending. Claims 1-16 are currently rejected. Claims 1, 4, and 13 are currently amended.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/04/2026, 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 Therefore, the rejection has been withdrawn.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 Gagnieux et al (US 20020156426 A1).
Applicant has argued on page 5 of the response that “the claimed structure ‘release element’ has a reasonably well understood meaning in the art”. Examiner notes that while some may well interpret a “release element” to be a spring as disclosed in Applicant’s specification, others may interpret a “release element” to be a trigger, button, plunger, or the like. Additionally, Applicant fails to present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function. As explained in MPEP § 2181, subsection I, claim limitations that meet the three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Therefore, the claim interpretation of these terms under 35 U.S.C. 112(f) is maintained.
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) 1-16 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).
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 bump (stop member 58) 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), and
wherein the 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 below) according to a central angle (see Jansen Modified Fig-1 below, central angle is formed between the two arrows; ALTERNATIVELY see Jansen Modified Fig-1.1 below, which notes a different interpretation of the central angle).
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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, and the bump protruding from a distal portion of the body.
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 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.
Regarding claim 2, Jansen modified by Gagnieux 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 modified by Gagnieux 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 4, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump comprises two bumps (“upper” bump outlined in black and “lower” bump outlined in light grey, both seen in Jansen Modified Fig-1 or Fig-1.1 above), and wherein the body (holder 26, fig. 1) comprises a first axial slot (opening 46A, fig. 3, [0037] One or more openings, such as openings 46A, 46B, are formed in the holder body.) and the two bumps arranged at both sides of said first axial slot (46A) (see Jansen Modified Fig-1 or Fig-1.1 above), and the central angle (see Jansen Modified Fig-1 or Fig-1.1 above) defined by the two bumps (48 and 48, see Jansen Modified Fig-1 or Fig-1.1 above, central angle is defined by both bumps).
Jansen is silent to wherein the central angle defined by the two bumps together is between 45-90°.
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 bumps such that it comprises a “central angle defined by the two bumps together is between 45-90°”.
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 defined by the two bumps together is between 45-90°” 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 modified by Gagnieux 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 bump (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 modified by Gagnieux 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 discloses modified by Gagnieux 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 modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump (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 9, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the body (holder 26, fig. 1) has a first axial slot (opening 46A, fig. 3) and a second axial slot opening 46B, fig. 3) ([0037] One or more openings, such as openings 46A, 46B, are formed in the holder body), the first axial slot (46A) and the second axial slot (46B) extending on both sides of the bump (48, fig. 1) ([0038] “stop member 48… is interrupted by the openings 46A, 46B”).
Regarding claim 10, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the body (holder 26, fig. 1) has a first axial slot (opening 46A, fig. 3, [0037]) extending from a proximal end of the body (see Jansen Modified Fig-1.2 below), and the bump is circumferentially distant ([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 said first axial slot (opening 46A, fig. 3).
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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. 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].
Regarding claim 11, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump (48, fig. 1) of the body (holder 26, fig. 1) has a first end (end of bump 48 which faces radially inward toward the longitudinal axis) provided with a chamfer (“inclined surface of the stop member 48”, noted in [0041]) extending in a circumferential direction (see fig. 1, bump 48 extends circumferentially and therefore the chamfer extends in a circumferential direction along structure of bump 48).
Regarding claim 12, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump (48, fig. 1) of the body (26, fig. 1) has a first end (right end of the bump 48 indicated in Jansen Modified Fig-5.1 below), an opposite second end (left end of the bump 48 indicated in Jansen Modified Fig-5.1 below), and a decreasing height (portion of bump outlined in grey in magnified portion of modified fig. 5 below) from said second end to said first end (see Jansen Modified Fig-5.1 below, height decreases in the noted portion of the bump moving from the second end to the first end).
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Regarding claim 13, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump comprises only two bumps (“upper” bump 48 outlined in black and “lower” bump 48 outlined in light grey, both seen in Jansen Modified Fig-1 or Fig-1.1 above).
Regarding claim 14, Jansen modified by Gagnieux discloses the safety device of claim 1, wherein the bump (48, fig. 1) has a first end (right hand end of bump 48 in fig. 5) and an opposite second end (left hand end of bump 48 in fig. 5), and the proximal abutment surface (proximal face of stop member 48, fig. 3, [0041]) of said bump (48) has a ramp portion (see indicated ramp portion in Jansen Modified Fig-5.2 below), said ramp portion having a decreasing slope towards the first end of said bump (see modified fig. below, surface inclined in direction toward proximal/ first end and therefore has a ‘decreasing’/ negative slope due to a negative change in ‘height’ of the inclined surface).
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Regarding claim 15, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the body (holder 26, fig. 1) has a first axial slot (opening 46A, fig. 3, [0037]) extending from a proximal end of the body (see Jansen Modified Fig-1.2 above).
Jansen 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 modified by Gagnieux discloses an injection device (medical device 10, fig. 1, [0032]) comprising a medical container (syringe 12, fig. 1, [0032]) having an injection needle (needle 18, fig. 1, [0033]) and the safety device (shield system 14, [0032]) of claim 1 (see 103 rejection of claim 1 above), said safety device being mounted onto said medical container (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 and 12 are alternatively rejected under 35 U.S.C. 103 as being obvious over Jansen modified by Gagnieux and further in view of Brunel (US 6186980 B1; hereafter Brunel).
Alternatively, regarding claim 8, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above.
Jansen modified by Gagnieux 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.
Alternatively, regarding claim 12, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump (48, fig. 1) of the body (26, fig. 1) has a first end (right end of the bump 48 indicated in Jansen Modified Fig-5.1 above), an opposite second end (left end of the bump 48 indicated in Jansen Modified Fig-5.1 above).
Jansen modified by Gagnieux is silent to a decreasing height from said second end to said first end.
Brunel, in the art of single-use devices for injection, teaches a decreasing height from said second end to said first end (see Brunel Modified Fig-3 below which shows a decreasing height from the second end to the first end of bump 22).
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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 bump of Jansen to have a decreasing height 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 bump 22 allows passage of the bump 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) 10 and 15 are alternatively rejected under 35 U.S.C. 103 as being obvious over Jansen modified by Gagnieux and further in view of Brunel2 (US 5855839 A; hereafter Brunel2).
Alternatively, regarding claim 10, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the body (holder 26, fig. 1) has a first axial slot (opening 46A, fig. 3, [0037]) extending from a proximal end of the body (see Jansen Modified Fig-1.2 below), and the bump is circumferentially distant ([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 said first axial slot (opening 46A, fig. 3).
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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).
Alternatively, regarding claim 15, Jansen modified by Gagnieux discloses the safety device of claim 1, as described above. Jansen further discloses wherein the body (holder 26, fig. 1) has a first axial slot (opening 46A, fig. 3, [0037]) extending from a proximal end of the body (see Jansen Modified Fig-1.2 above).
Jansen modified by Gagnieux is silent to wherein the first axial slot extends from a distal end of said body (instead of a proximal end of the body), and the first axial slot having a predetermined length comprised between 1mm - 6 mm.
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).)
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 Brunel2) 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).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 5 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 10 of copending Application No. 18/088089. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/088089.
Although the claims at issue are not identical, they are not patentably distinct from each other because each noted claim contains all information of the independent claim and includes additional limitations, so the independent claim of the instant application is essentially a genus claim which is anticipated by each noted copending claim which is essentially a species claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application 18/088089, in view of Jansen.
18/088089 includes dependent claims which include all the limitations of claims 5-16 except for “wherein the bump extends in a circumferential direction according to a central angle comprised between 22.5°-45°.” .
Jansen, in the field of safety devices for syringes, teaches wherein the 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 below) according to a central angle (see Jansen Modified Fig-1 below, central angle is formed between the two arrows; ALTERNATIVELY see Jansen Modified Fig-1.1 below, which notes a different interpretation of the central angle).
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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 have the bump extend circumferentially since all reference applications note that the bump includes an abutment surface for engaging with an abutment surface of a needle shield which is positioned within the tubular body. Since the abutment surface of the bump is thus formed on the inside of the tubular body, having the bump extend circumferentially allows for engagement with an element within the tube and beneficially, predictably, keeps that element at the same longitudinal position regardless of rotational orientation.
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 bump to extend circumferentially and to modify the central angle forming the circumferential length of the bump 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).)
Similar reasoning in view of Jansen would further make obvious the limitations of claims 2-4, as outlined in the 103 rejections of claims 1-4 over Jansen above. As such, claims 2-4 are also rejected for double patenting over copending application 18/088089 in view of Jansen.
This is a provisional nonstatutory double patenting rejection.
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/24/2026