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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3, 10-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Komann (US Patent Pub. 20160129193) in view of Evans (US Patent Pub. 20080243088).
Regarding Claim 1, Komann teaches (Figs 1 and 4) a syringe (10) comprising:
a tubular barrel (12) for receiving a medical product; and
a plastic flange (40 in Fig. 4; [0040] and [0044]) protruding from an external surface of said tubular barrel (12) so as to provide a user's fingers support (see [0100]), said plastic flange comprising:
an opening (51) defined by the plastic flange (40);
a peripheral collar (42) surrounding the opening (51), said peripheral collar providing a support to a user's fingers (see [0100] teaching 42 is finger flange);
a through-aperture (44) configured to allow passage of a plunger rod (18; see Fig 1) into a reservoir (13) defined by the tubular barrel (12) of the syringe (10), said plastic flange (40) adapted for connection to an external surface of the tubular barrel (12) of the syringe through the opening of the plastic flange (See [0106], Figs 1, 4 where flanges 20,40 are connected to the top of 12), the through-aperture defining a lower diameter than the opening and being proximally located relative to the opening (See annotated Fig 4; [0102]);
a distal shoulder (41) separating the opening (51) and the through-aperture (44).
Komann does not teach a plastic flange comprising a remotely readable electronic component for remote identification of the syringe, said remotely readable electronic component being at least partially embedded into the plastic flange, the remotely readable electronic component being an RFID tag including an RFID antenna extending proximal to the distal shoulder.
Evans teaches a syringe (100) with RFID tags (120) that are mounted on or within a flange (108; see [0052] “tags 120 may be mounted on or within a finger platform 108”). Evans further teaches the RFID tags include one or more antennae (See [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flange of Komann such that it included a remotely readable electronic component for remote identification of the syringe, said remotely readable electronic component being at least partially embedded into the plastic flange, the remotely readable electronic component being an RFID tag including an RFID antenna extending proximal to the distal shoulder as taught by Evans. One of ordinary skill in the art would have been motivated to do so in order to transmit information about the contents of the syringe to a receiver (Evans [0017]).
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Annotated Fig 4 (Komann)
Regarding Claim 3, the combination of Komann and Evans teaches the syringe according to claim 1, wherein the plastic flange is connected to the tubular barrel by gluing (Komann [0053]), screwing or fitting (Komann [0104], Fig 4, 46,47).
Regarding Claim 10, the combination of Komann and Evans teaches the syringe according to claim 1, wherein the tubular barrel (12) is made of a glass material (see Komann [0056] and [0077]).
Regarding Claim 11, Komann teaches (Figs 1, 4) a method for manufacturing a syringe (10) comprising:
a tubular barrel (12) for receiving a medical product; and
a plastic flange (40; [0040]) protruding from an external surface of said tubular barrel (12) so as to provide a user's fingers support (see [0100]), said plastic flange comprising:
an opening (51) defined by the plastic flange (40);
a peripheral collar (42) surrounding the opening (51), said peripheral collar providing a support to a user's fingers (see [0100] teaching 42 is finger flange);
a through-aperture (44) configured to allow passage of a plunger rod (18; see Fig 1) into a reservoir (13)defined by the tubular barrel (12) of the syringe (13), said plastic flange (40) adapted for connection to an external surface of the tubular barrel (12) of the syringe through the opening of the plastic flange (See [0106], Figs 1, 4 where flanges 20,40 are connected to the top of 12), the through-aperture defining a lower diameter than the opening and being proximally located relative to the opening (see annotated Fig 4; [0102]);
a distal shoulder (41) separating the opening (51) and the through-aperture (44).
said method comprising the steps of: connecting the plastic flange (40) to the tubular barrel (12), wherein the plastic flange is adapted for connection to an external surface of the tubular barrel of the syringe through the opening of the plastic flange (See [0106], Figs 1, 4 where flanges 20,40 are connected to the top of 12).
Komann does not teach a plastic flange comprising a remotely readable electronic component for remote identification of the syringe, said remotely readable electronic component being at least partially embedded into the plastic flange, the remotely readable electronic component being an RFID tag including an RFID antenna extending proximal to the distal shoulder.
Evans teaches a syringe (100) with RFID tags (120) that are mounted on or within a flange (108; see [0052] “tags 120 may be mounted on or within a finger platform 108”). Evans further teaches the RFID tags include one or more antennae (See [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flange of Komann such that it included a remotely readable electronic component for remote identification of the syringe, said remotely readable electronic component being at least partially embedded into the plastic flange, the remotely readable electronic component being an RFID tag including an RFID antenna extending proximal to the distal shoulder as taught by Evans. One of ordinary skill in the art would have been motivated to do so in order to transmit information about the contents of the syringe to a receiver (Evans [0017]).
Regarding Claim 12, the combination of Komann and Evans teaches the method according to claim 11 further comprising: distributing a glue material between the plastic flange and the tubular barrel (Komann [0053]).
Regarding Claim 14, the combination of Komann and Evans teaches the method according to claim 11 further comprising: snap fitting the plastic flange onto the external surface of the tubular barrel (Komann [0104], Fig 4, 46,47).
Claim(s) 4-8, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Komann (US Patent Pub. 20160129193) in view of Evans (US Patent Pub. 20080243088) as applied to claim 1 above, and further in view of Witowski (US Patent Pub. 20070088284).
Regarding Claim 4, the combination of Komann and Evans teaches all elements of claim 1 as described above. The combination does not specify the syringe wherein the plastic flange comprises a plurality of bumps radially protruding from an inner lateral wall of the plastic flange and configured to abut against the external surface of the tubular barrel.
Witowski teaches (Fig 2) a flange (8) comprising a plurality of bumps (11) radially protruding from an inner lateral wall of the plastic flange (8) configured to abut against the external surface of the tubular barrel (2; see [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner lateral wall (42) of the flange of Komann such that it includes a plurality of bumps radially protruding from an inner lateral wall of the plastic flange and configured to abut against the external surface of the tubular barrel as taught by Witowski. One of ordinary skill in the art would have been motivated to do so in order to prevent twisting of the gripping edge (See Witowski [0007]).
Regarding Claim 5, the combination of Komann, Evans and Witowski teaches the syringe according to claim 4, wherein the plurality of bumps comprises proximal blocking surfaces (Witowski 11) configured to abut against a circular bead (Komann syringe rim 11) protruding from an external lateral surface at the proximal end of the tubular barrel (Komann 12).
Regarding Claim 6, the combination of Komann, Evans and Witowski teaches the syringe according to claim 5, wherein the distal shoulder is configured to abut the proximal end of the tubular barrel and arranged opposite the proximal blocking surfaces (in the modified Komann, the proximal blocking surfaces are on 42, which is opposite to the shoulder 41).
Regarding Claim 7, the combination of Komann, Evans and Witowski teaches all elements of claim 4 as described above. The combination further teaches the syringe wherein adjacent bumps of said plurality of bumps (Witowski 11) define an axial channel (space between Witowski 11 in Fig 2) configured to be filled with a glue material (this is considered an intended use limitation; the channels are capable of being filled with a glue material).
Regarding Claim 8, the combination of Komann, Evans and Witowski teaches all elements of claim 7 as described above. The combination further teaches the syringe wherein the remotely readable electronic component is embedded between the plastic flange and the glue material (Komann [0053]).
Regarding Claim 15, the combination of Komann, Evans and Witowski teaches all elements of claim 7 as described above. The combination further teaches the syringe wherein the plastic flange comprises at least one circular channel establishing a fluid connection between adjacent axial channels (See annotated Fig 4; the examiner notes this is similar to how the instant application shows the circular channel 166 in Fig 8).
Regarding Claim 18, the combination of Komann, Evans and Witowski teaches all elements of claim 4 as described above. The combination further teaches the syringe wherein the plurality of bumps are configured to block a distal movement of the tubular barrel relative to the plastic flange (See Witowski [0050]).
Claim(s) 9, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Komann (US Patent Pub. 20160129193) in view of Evans (US Patent Pub. 20080243088) as applied to claim 1 above, and further in view of Davidowitz (US Patent Pub. 20110199187).
Regarding Claim 9, the combination of Komann and Evans teaches all elements of claim 1 as described above. The combination does not specify wherein the remotely readable electronic component is totally overmolded in the plastic flange
Davidowitz teaches [0093] that the RFID tag (804) is encapsulated within groove (807) of collar (800; this is considered to be an ‘overmolded’ configuration of the RFID tag).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flange of the modified Komann such that the remotely readable electronic component is totally overmolded as taught by Davidowitz. One of ordinary skill in the art would have recognized this as a way to protect the RFID tag and antenna (Davidowitz [0093]).
Regarding Claim 16, the combination of Komann and Evans teaches all elements of claim 1 as described above. The combination does not specify wherein the antenna extends at least partially around a circumference of the opening.
Davidowitz teaches (fig 8) a RFID tag (804) with an antenna that goes extends around a circumference of an opening (805).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antenna of the modified Komann such that the antenna extends at least partially around a circumference of the opening as taught by Davidowitz. One of ordinary skill in the art would have been motivated to do so in order to function as a loop antenna (Davidowitz [0093]).
Regarding Claim 17, the combination of Komann, Evans and Davidowitz teaches all elements of claim 16 as described above. The combination further teaches the antenna extends around all the circumference of the opening (See Davidowitz Fig 8, antenna 802 extends around the circumference of opening 805).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Komann (US Patent Pub. 20160129193) in view of Evans (US Patent Pub. 20080243088) as applied to claim 11 above, and further in view of Brockway (US Patent 1798116).
Regarding claim 13, the combination of Komann and Evans teaches all elements of claim 11 as described above. The combination does not teach the method further comprising screwing the plastic flange onto the external surface of the tubular barrel.
Brockway teaches (Col 1 line 47- Col 2 line 1) a syringe with a flange that is screwed onto the external surface of the barrel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe of Komann such that the method comprised the step of screwing the plastic flange onto the external surface of the tubular barrel as taught by Brockway. One of ordinary skill in the art would recognize this as another way to connect the flange to the tubular barrel.
Response to Arguments
Applicant's arguments filed 10/6/2025 have been fully considered but they are not persuasive.
As to the remarks on Pg. 5 lines 4 – Pg. 7 line 5, the applicant argues that the combination of Komann and Evans does not teach or support modifying the finger flange to include RFID tags. The applicant argues that the RFID tags of Evans is not on the finger flange, rather Evans teaches the RFID tags on the body of the syringe. The examiner does not find this to be persuasive. The examiner has cited [0052] of Evans which specifies “tags 120 may be mounted on or within a finger platform 108”. Referring to Evans Fig 1 and Komann Fig 4, Evans (109) is a rim similar to Komann (11), and Evans (108) is a finger platform/flange similar to Komann (40). As such, it would have been obvious to make the modification of Komann in view of Evans to result in the RFID tag being placed in the finger flange of Komann, not the rim/projection 11. For these reasons the rejection is maintained.
As to the remarks on Pg. 7 line 6 - Pg. 8 line 5, the applicant argues that the modification purpose in view of Witowski is not proper, nor does it solve any issues in Komann, and therefore would not be obvious. The examiner does not find this persuasive. The applicant first argues that the motivation for modification in Witowski is for a different structure, specifically that the spring elements 28 are what allow for the prevention of twisting in Witowski, not the bumps/catches 11. Witowski [0043] teaches that the catches 11 provide a more secure seat of the gripping edge. Witowski [0007] teaches the overall purpose of the invention is to improve the gripping edge and prevent twisting. The catches 11 in turn provide this improvement to the gripping edge, and as such the examiner interprets that the ‘more secure seat’ would also provide the benefit of preventing twisting. Secondly, the applicant argues that the design of Komann already prevents twisting. The examiner takes the position that Witowski provides an alternative design that would also allow for the similar prevention of twisting. One of ordinary skill in the art could have modified Komann to include the caches/bumps of Witowski to further secure the gripping area and prevent twisting or as an alternative design to prevent the twisting of the finger flange in relation to the syringe body. For these reasons the rejection is maintained.
As to the remarks on Pg. 8 line 6 – end of Pg 9, the applicant argues that the modification in view of Davidowitz would not anticipate the remotely readable electronic component overmolded in the plastic flange. The applicant argues that the RFID in Davidowitz is mounted on a vial. Since the vial does not have any similar structures to Komann, the applicant argues there is no teaching or motivation to modify Komann in view of Davidowitz. The examiner does not find this persuasive. The combination of Komann and Evans already teaches an RFID in the finger flange of the device. The combination does not specify the RFID being ‘totally overmolded’ within the finger flange. Davidowitz teaches a RFID tag that is used within a same field of art, a medical vial, that is fully encapsulated within a groove of a collar (see [0093]). This encapsulation of the RFID tag within a collar of the vial is considered to be similar to a RFID tag within a finger flange (the finger flange could broadly be considered a collar of the barrel of syringe, and the barrel of the syringe is considered to be a similar structure of a vial). Furthermore, the motivation of protecting the RFID by overmolding/encapsulating the RFID, would be similarly applicable to an RFID in the finger flange as taught by the combination of Komann and Evans. As such, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783