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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/23/2026 has been entered.
Status of the Claims
Claim 3 is cancelled. Claims 1-2 and 4 are currently amended. Claims 1-2 and 4-16 are currently pending. Claims 1-2 and 4-16 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/23/2026, 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 Therefore, the rejection has been withdrawn.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 Righi et al (US 5163918 A).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “conical surface contact” (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed 06/23/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: claim 1 as amended recites “wherein the chamfer of the distal abutment surface of the needle cover and the chamfer of the proximal abutment surface of the bump have the same constant inclination such that a contact between the distal abutment surface of the needle cover and the proximal abutment surface of the bump is a conical surface contact instead of a line contact.”. Emphasis is added to indicate that in particular, the “conical surface contact” is regarded as new matter since this was not previously described in the application, nor shown in the drawings.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 4-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a “conical surface contact” in the last line.
The instant specification [0071] includes the following lines:
“Due to the complementary shape of these chamfers, the contact between of the activation ring 41 and the bumps 35 is a surface contact, instead of a line contact. This helps reduce the activation force and its variability.”
“The activation ring 41 thus comprises a frustoconical distal surface easing the passage of the needle cover 4 over the bumps 35 of the body 3”
Examiner notes that the instant specification appears to provide support for a frustoconical surface contact, but not a full conical surface contact, which invokes a fully formed and closed cone rather than a portion of a conical surface as shown in the figures and expressed in the specification by the description of the “frustoconical distal surface”.
In order to overcome this 112(a) issue, the Examiner recommends replacing “conical surface contact” in claim 1 with “frustoconical surface contact”.
Claims 2 and 4-16 are also rejected under 112(a) at least for depending on claim 1, and claims inherit the deficiencies of those claims from which they depend.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 4-16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the same constant inclination” in the third to last line. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted to read “a same constant inclination”.
Claim 1 recites the limitation “a conical surface contact instead of a line contact”. It is unclear what the meaning of “line contact” could be such that having a surface contact would not inherently include one or more “line contacts” as well. The instant specification provides support for having a surface contact instead of a line contact but does not provide any specific definition of a line contact such that it is clear what this distinction entails. Furthermore, it is unclear whether this limitation in the claim means that a surface contact is exclusive to a line contact, or that the contact is a surface contact because it has more than a single line contact. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation. Examiner suggests removing the phrase “instead of a line contact” from the claim language.
Claim 1 recites the limitation “a conical surface contact”. It is unclear how a conical surface contact, formed of two entire cone silhouettes, could work with the other components of the device, as the two pieces would be unable to slide past each other if the surface contact was a cone covering the entire inner lumen of the body. Is this limitation meant to convey a partial conical surface contact, such as a frustoconical contact, or a contact which comprises a curve of any sort? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2 and 4-16 are also rejected under 112(b) at least for depending on claim 1, and claims inherit the deficiencies of those claims from which they depend.
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) and further in view of Righi et al (US 5163918 A; hereafter Righi).
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 (see fig. 1), 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 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 48) 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 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]) each comprise 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]).
Jansen 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.
Jansen as modified by Gagnieux is silent to wherein the chamfer of the distal abutment surface of the needle cover and the chamfer of the proximal abutment surface of the bump have the same constant inclination such that a contact between the distal abutment surface of the needle cover and the proximal abutment surface of the bump is a conical surface contact instead of a line contact.
Righi, in the art of safety syringes, teaches wherein the chamfer of a distal abutment surface (distal abutment surface noted in annotated fig. 9 below, col. 4 ln. 42-64) and the chamfer of a proximal abutment surface (slanted abutment surface 18, fig. 9, col. 4 ln. 56-59 “slanted abutment face 18 which is downwardly inwardly inclined”) having the same constant inclination (see 112b interpretation above) (col. 4 ln. 59-64, “Abutment faces 18 cooperate with the correspondingly inclined peripheral edge of a disc-shaped pusher member 19”).
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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 chamfer of the distal abutment surface of the needle cover and the chamfer of the proximal abutment surface of the bump of Jansen modified by Gagnieux to have the same constant inclination, as taught by Righi, such that a contact between the distal abutment surface of the needle cover and the proximal abutment surface of the bump is a conical surface contact (see 112b interpretation above; note 112a rejection) instead of a line contact, since all three references deal with syringes and abutment surfaces. One would have been motivated to make the modification because having the surfaces have the same inclination ensures good cooperation between the abutment surfaces.
Regarding claim 2, Jansen as modified discloses the safety device of claim 1, as described above, including wherein the chamfer of the distal abutment surface and the chamfer of the bump have a frustoconical shape (Jansen: see bump 48 in fig. 5 which shows that the chamfer of the bump 48 has a frustoconical shape) (Righi: see fig. 9 and col. 4 ln. 56-64 which describes the constant inclination of the surface, such that as modified both chamfers have a frustoconical shape).
Regarding claim 4, Jansen as modified discloses the safety device of claim 1, as described above, including wherein the chamfer of the distal abutment surface (Jansen: distal face of stop member 58, fig. 5, [0041]) and the chamfer of the bump (Jansen: 48, fig. 5) are inclined with regard to the longitudinal axis (Jansen: see fig. 5, note [0041] stop member 58 has an inclined surface which is engageable with the inclined surface of the stop member 48 on the holder) (Righi: Righi: see fig. 9 and col. 4 ln. 56-64 which describes the constant inclination of the surface).
Jansen as modified is silent to the chamfer being specifically inclined 45° with regard to the longitudinal axis. This limitation represents only a change in shape (MPEP 2144.04(IV)(A)). Altering the engagement angle of the two chamfers would not adversely affect the functionality of Jansen. So long as the chamfers have engageable inclined surfaces, the device would still function appropriately. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to specify the angle of the chamfers to be 45°, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05 II. A). One would have been motivated to make the modification because having the inclined surfaces both be 45° evenly distributes the load of the engagement force along the longitudinal and axial direction of each of the stop members 48/58.
In addition, it is observed that the inclined angle of the chamfer is a result effective variable because the angle of the chamfer affects how much force applied to the stop members 48/58 is orthogonal to the chamfer, thus affecting the amount of friction which maintains the stop members 48/58 in engagement prior to the additional force being applied to disengage the stop members. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the inclined surfaces both be 45°, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 5, Jansen as modified 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 6, Jansen as modified 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 7, Jansen as modified 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 8, Jansen as modified 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 9, Jansen as modified 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 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. 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 10, Jansen as modified discloses the safety device of claim 1, as described above. Jansen further discloses 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).)
Regarding claim 11, Jansen as modified 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 as modified 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 as modified discloses the safety device of claim 1, as described above. Jansen further discloses wherein the bump comprises two bumps, and wherein the device includes 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 as modified discloses the safety device of claim 1, as described above. Jansen further discloses 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 as modified 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 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, as applied to claim 1 above, 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) 7 and 12 are alternatively rejected under 35 U.S.C. 103 as being obvious over Jansen modified by Gagnieux and Righi in view of Brunel (US 6186980 B1; hereafter Brunel).
Alternatively, regarding claim 7, Jansen as modified discloses the safety device of claim 1, as described above.
Jansen as modified 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 as modified 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 as modified 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) 9 and 15 are alternatively rejected under 35 U.S.C. 103 as being obvious over Jansen modified by Gagnieux and Righi in view of Brunel2 (US 5855839 A; hereafter Brunel2).
Alternatively, regarding claim 9, Jansen as modified 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 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.
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 as modified 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 as modified 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 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.
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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
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
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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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