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
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.
Claims 1-4, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Peuke et al. (US 20160058947 A1) in view of Ang (US 20130053773 A1) in further view of Stepovich et al. (US 20090292271 A1) in view of Cheetham (US 9775690 B2) in further view of Cheikh (US 6349850 B1).
Regarding Claim 1, Peuke discloses a one-step anesthetic buffering carpule (syringe 10, Fig 1-3) comprising: a carpule (cartridge 11, Fig 1) having a carpule first end (rear end 16, Fig 1) and a carpule second end (front end 23, Fig 1); a liquid anesthetic (first liquid 18; [0003]) contained within the carpule (11) (Fig 1); a capsule (plug 12, Fig 1) having an open capsule end (open rear end of 12, Fig 1-3) and an opposite closed capsule end (front end of 12 closed by wall 21, Fig 1-3) at least partially disposed within the carpule (11) proximate the carpule first end (16) so as to fluidly seal the carpule first end (16); a buffer (second liquid 19, Fig 1; [0003]) contained within the capsule (12) ([0042]); an activator (activator member 13, Fig 1) at least partially disposed proximate the buffer (19) and extending from the carpule first end (11) (Annotated Fig 1;[0043]) having an activator first end (rear end of activator 13) and an activator second end (piercing member 22, Fig 1) wherein a knob (rear end of 13 has a knob shape) is located on the activator first end (rear end of activator 13).
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Peuke discloses ([0003]: “There are further syringes which facilitate mixing of an anesthesia and a buffer. For example U.S. 2009/292271 A1 discloses a device for delivering a buffer solution into a buffer cartridge”); However the embodiment of Fig 1-3 is silent regarding the composition of the first liquid as a liquid anesthetic and second liquid as a buffer; and two harpoons positioned on the activator second end, the activator second end having the harpoons is sized to sealingly fit in the open capsule end of the capsule such that when the activator second end is depressed through the capsule punctures the opposite capsule closed end, a soft rubber plug positioned in an open interior portion of the knob.
Ang teaches a device (syringe 100, Fig 2A) comprising a capsule (piston 130, Fig 2A) comprising an open capsule end (chamfered edge 1350, Fig 3E) and a closed end (front surface 1320, Fig 3E); an activator (plunger 120, Fig 2A) having a first end (stem 1290, Fig 3A and end cap 1100 Fig 2A) and a second end (cutting crown 1200, Fig 3A); two harpoons (cutting teeth 1220, Fig 3C) are positioned on the activator second end (1200), the activator second end (1200) having the harpoons (1220) is sized to sealingly fit in the open capsule end (1350) of the capsule (130) such that when the activator second end (1200) is depressed through the capsule (130) punctures the opposite capsule closed end (1320).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the activator of device of Peuke with an activator having two harpoons at the first end sealing an open capsule end as taught by Ang to perforate the capsule and prevent recycling of the device ([0085])
Peuke/Ang are silent regarding the device comprising a liquid anesthetic and a buffer; a soft rubber plug positioned in an open interior portion of the knob.
Stepovich teaches a device (buffer transfer device 10, Fig 6) comprising a liquid anesthetic (anesthetic inside cartridge 28; Fig 6) contained within the carpule (cartridge 28, Fig 6) and a buffer (buffer inside cartridge 16, Fig 6) contained within the capsule (cartridge 16, Fig 6)([0043]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the first and second liquid of device of Peuke/Ang with a liquid anesthetic and a buffer as taught by Stepovich to improve effectiveness of the anesthetics and to reduce injection pain in dentistry applications ([0013])
Peuke/Ang/Stepovich are silent regarding a soft rubber plug positioned in an open interior portion of the knob.
Cheetham teaches a device (Fig 1-3) comprising an activator (plunger 18+ protrusion 42, Fig 1) further comprising a knob (plunger 18, Fig 1) has an open interior portion (open interior of shaft 18 as seen in Fig 1-3) for receipt of a soft rubber plug (open interior of shaft 18 is capable of receiving a soft rubber plug).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Peuke/Ang/Stepovich with a similar hollow knob as taught by Cheetham for the purpose of reducing weight and hand fatigue and improve the actuation experience of the user by having a portion of the knob extending from the device (Col 2, lines 43-49; Fig 1)
Peuke/Ang/Stepovich/Cheetham are silent regarding a soft rubber plug positioned in an open interior portion of the knob.
Cheikh teaches a method (Fig 46) comprising a spindle 115; an activator (cartridge-septum 108+ short needle 109+ piston 114, Fig 46) comprising a soft rubber plug (piston 114, Fig 46) positioned in an open interior portion of the knob (open end of cartridge-septum 108, Fig 46).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Peuke/Ang/Stepovich/Cheetham with similar piston connected to spindle as taught by Cheikh for the purpose of facilitating the mixing and injection process (Col. 11, lines 49-62).
Regarding Claim 2, Peuke/Ang/Stepovich/Cheetham/Cheikh discloses the one-step anesthetic buffering carpule according to claim 1. Peuke discloses wherein the capsule (12) is a rubber plunger ([0045]: “the plug 12 and the seal film may be made of a resilient plastic or rubber material”) fully disposed within the carpule (11) first end (16) ([0042]: “The main chamber 14 is sealed by the plug 12 at a rear end 16 of the cartridge 11”).
Regarding Claim 3, Peuke/Ang/Stepovich/Cheetham/Cheikh discloses the one-step anesthetic buffering carpule according to claim 2. Peuke discloses further comprising: a rubber seal (sealed outlet 24, Fig 1; [0045]: “the plug 12 and the seal film may be made of a resilient plastic or rubber material.”) disposed at the carpule (11) second end (23) for receiving a needle ([0045]: “the cartridge 11 has a seal film that can be pierced open, for example by an injection needle”); and the activator (13) is disposed within the rubber plunger (12) (Fig 1) and extends from the carpule (11) first end (16) ([0043]: “The activator member 13 is slidably received within the second tubular portion 20 for sealing the auxiliary chamber 15”).
Regarding Claim 4 Peuke/Ang/Stepovich/Cheetham/Cheikh discloses the one-step anesthetic buffering carpule according to claim 3. Peuke discloses wherein the activator (13) is a puncture unit (activator member 13 is a puncture unit having the piercing member 22) actuated from a first position (Fig 1) to a second position (Fig 3) so as to release the buffer (19, from Peuke modified with the teaching of Stepovich, see modification of claim 1) from the rubber plunger (12) and combine the buffer (19, from Peuke modified with the teaching of Stepovich, see modification of claim 1) with the liquid anesthetic (18, from Peuke modified with the teaching of Stepovich, see modification of claim 1) (Fig 2-3; [0044]).
Regarding Claim 11, Peuke discloses a one-step anesthetic buffering method comprising: disposing a rubber plunger (plug 12, Fig 1) having an open first end (open rear end of 12, Fig 1-3) and a closed second end (front end of 12 closed by wall 21, Fig 1-3) within a carpule (cartridge 11, Fig 1) containing an anesthetic (first liquid 18; [0003]); containing a liquid buffer (second liquid 19, Fig 1; [0003]) within the rubber plunger (12); sealing the liquid buffer (second liquid 19, Fig 1; [0003]) in the rubber plunger (12) with a puncture unit (activator member 13, Fig 1), wherein the puncture unit has a first end (rear end of activator 13) and a second end (piercing member 22, Fig 1); actuating the puncture unit (13) from a first position (Fig 1) to a second position (Fig 3) so as to unseal the closed second end (front end of 12 closed by wall 21) of rubber plunger (12) by depressing the puncture unit (13) through the rubber plunger (12) (Fig 3); the second end (piercing member 22, Fig 1) of the puncture unit (13) pierce the closed second end (front end of 12 closed by wall 21) of the rubber plunger (12) thereby mixing the liquid buffer (second liquid 19, Fig 1; [0003]) with the anesthetic (first liquid 18; [0003]). Peuke discloses ([0003]: “There are further syringes which facilitate mixing of an anesthesia and a buffer. For example U.S. 2009/292271 A1 (…)”
However, the embodiment of Fig 1-3 is silent regarding the composition of the first liquid as a liquid anesthetic and second liquid as a buffer; the first end has an open interior for receipt of a soft rubber plug; the second end of the puncturing unit sized to sealingly fit within the open first end of the rubber plunger; two harpoons positioned around a perimeter of a cylindrical portion of the second end of the puncture unit; and aspirating a syringe through the soft rubber plug positioned in the open interior of the first end of the puncture unit.
Ang teaches a method (syringe 100, Fig 2A) comprising a rubber plunger (piston 130, Fig 2A) comprising an open first end of the rubber plunger (chamfered edge 1350, Fig 3E) and a closed second end of rubber plunger (front surface 1320, Fig 3E); a puncturing unit (plunger 120, Fig 2A) having a first end (stem 1290, Fig 3A and end cap 1100 Fig 2A) and a second end (cutting crown 1200, Fig 3A); the second end (1200) of the puncturing unit (120) sized to sealingly fit within the open first end (1350) of the rubber plunger (130) two harpoons (cutting teeth 1220, Fig 3C) positioned around a perimeter of a cylindrical portion of the second end (perimeter of 1200, Fig 3A) of the puncture unit (120).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the puncturing unit of method of Peuke with a puncturing unit having two harpoons positioned around a perimeter of a cylindrical portion of a second end, sized to sealingly fit within an open first end of a rubber plunger as taught by Ang to perforate the capsule and prevent recycling of the device ([0085]).
Peuke/Ang are silent regarding the method comprising a liquid anesthetic and a buffer; the first end has an open interior for receipt of a soft rubber plug; and aspirating a syringe through the soft rubber plug positioned in the open interior of the first end of the puncture unit.
Stepovich teaches a method of mixing a liquid buffer with an anesthetic (abstract) comprising a liquid anesthetic (anesthetic inside cartridge 28; Fig 6) contained within the carpule (cartridge 28, Fig 6) and a buffer (buffer inside cartridge 16, Fig 6) contained within the capsule (cartridge 16, Fig 6)([0043]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the first and second liquid of method of Peuke/Ang with an anesthetic and a buffer solution as taught by Stepovich to optimize effectiveness of the anesthetics and to reduce injection pain in dentistry applications ([0013])
Peuke/Ang/Stepovich are silent wherein the first end has an open interior for receipt of a soft rubber plug; and aspirating a syringe through the soft rubber plug positioned in the open interior of the first end of the puncture unit.
Cheetham teaches a method (Fig 1-3) comprising an activator (plunger 18+ protrusion 42, Fig 1) further comprising a first end (plunger 18, Fig 1) has an open interior (open interior of shaft 18 as seen in Fig 1-3) for receipt of a soft rubber plug (open interior of shaft 18 is capable of receiving a soft rubber plug).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Peuke/Ang/Stepovich with a similar first end as taught by Cheetham for the purpose of reducing weight and hand fatigue and improve the actuation experience of the user by having a portion of the knob extending from the device (Col 2, lines 43-49; Fig 1).
Peuke/Ang/Stepovich/Cheetham are silent regarding aspirating a syringe through the soft rubber plug positioned in the open interior of the first end of the puncture unit.
Cheikh teaches a method (Fig 46) comprising a spindle 115; an activator (cartridge-septum 108+ short needle 109+ piston 114, Fig 46) comprising a soft rubber plug (piston 114, Fig 46) positioned in an open interior portion of the knob (open end of cartridge-septum 108, Fig 46); aspirating a syringe through the soft rubber plug (114) positioned in the open interior (open end of cartridge-septum 108, Fig 46) of the first end of the puncture unit (108+109+114) (Col 10; lines 26-29; discloses suctioning through a similar spindle and plug).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Peuke/Ang/Stepovich/Cheetham with similar piston connected to spindle as taught by Cheikh for the purpose of facilitating the mixing and injection process (Col. 11, lines 49-62).
Regarding Claim 14, Peuke/Ang/Stepovich/Cheetham/Cheikh discloses the one-step anesthetic buffering method according to claim 11. Peuke discloses further comprising a rubber seal (sealed outlet 24; [0045]: “the seal film may be made of a resilient plastic or rubber material.”) disposed at a carpule (cartridge 11, Fig 1-3) second end (front end 23, Fig 1-3) for receiving a needle (needle;[0045]) for extracting the buffered anesthetic (Fig 3) from the carpule (11) ([0045]; film is being pierced by a needle capable of extracting the buffer/anesthetic solution).
Claim 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Peuke et al. (US 20160058947 A1) in view of Ang (US 20130053773 A1) in further view of Stepovich et al. (US 20090292271 A1) in view of Cheetham (US 9775690 B2) in view of Cheikh (US 6349850 B1) in further view of Larson (US 20140170594 A1).
Regarding Claim 5, Peuke/Ang/Stepovich/Cheetham/Cheikh discloses the one-step anesthetic buffering carpule according to claim 4 wherein the rubber plunger (12) has a bladder portion (plug front wall 21, Fig 1-3) and an outer ribbed portion (second tubular portion 20, Fig 1-3). Peuke/Ang/Stepovich/Cheetham/Cheikh are silent wherein the bladder portion is softer than the outer ribbed portion.
Larson teaches a device (carpule, Fig 2) comprising a plunger (piston 78, Fig 90) wherein a bladder portion (membrane 94, Fig 2) is softer than the outer ribbed portion (ribs 80, Fig 2) ([0036]; claim 5; Membrane of thickness .0001in made of silicone is softer than ribs 80).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the bladder of device of Peuke/Ang/Stepovich/Cheetham/Cheikh with a similar bladder as taught by Larson for the purpose of reduce the resistance to puncture ([0036]: “membrane 94 does not provide a significant resistance to puncture”).
Regarding Claim 6 Peuke/Ang/Stepovich/Cheetham/Cheikh/Larson discloses the one-step anesthetic buffering carpule according to claim 5. Peuke discloses wherein the puncture unit (13) has a generally larger cylindrical first end (30, Annotated Fig 1 ) extending from the carpule (11) (Annotated Fig 1) and a generally smaller cylindrical second end (piercing member 22, Fig 1) disposed within the rubber plunger (12) (Fig 1; [0043]: “the activator member 13 has a piercing member 22 that protrudes from the activator member toward the plug front wall 21 for piercing the plug front wall 21 upon movement of the activator member 13 in the first direction”).
Regarding Claim 7, Peuke/Ang/Stepovich/Cheetham/Cheikh/Larson discloses the one-step anesthetic buffering carpule according to claim 6. Peuke discloses wherein the generally smaller end (22) of the puncture unit (13) is configured to pierce the rubber plunger (12) so as to release the buffer (19, from Peuke modified with the teaching of Stepovich, see modification of claim 1) into the liquid anesthetic (18, from Peuke modified with the teaching of Stepovich, see modification of claim 1) ([0043]; Fig 2-3).
Regarding Claim 8, Peuke/Ang/Stepovich/Cheetham/Cheikh/Larson discloses the one-step anesthetic buffering carpule according to claim 7. Peuke is silent wherein the two harpoons are positioned around a perimeter of the smaller cylindrical second end of the puncture unit.
Ang teaches a device (syringe 100, Fig 2A) comprising a capsule (piston 130, Fig 2A) comprising an open capsule end (chamfered edge 1350, Fig 3E) and a closed end (front surface 1320, Fig 3E); a puncturing unit (plunger 120, Fig 2A) having a first end (stem 1290, Fig 3A and end cap 1100 Fig 2A) and a second end (cutting crown 1200, Fig 3A); two harpoons (cutting teeth 1220, Fig 3C) are positioned on the activator second end (1200), the activator second end (1200) having the harpoons (1220) is sized to sealingly fit in the open capsule end (1350) of the capsule (130) such that when the activator second end (1200) is depressed through the capsule (130) punctures the opposite capsule closed end (1320). Ang further teaches wherein the two harpoons (1220) are positioned around a perimeter of the smaller cylindrical second end (perimeter of 1200) of the puncture unit (120)(Fig 3A).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the location of harpoons of device of Peuke/Ang/Stepovich/Cheetham/Cheikh /Larson to be positioned around a perimeter of the smaller cylindrical second end as taught by Ang to perforate the capsule and prevent recycling of the device ([0085]).
Regarding Claim 9, Peuke/Ang/Stepovich/Cheetham/Cheikh/Larson discloses the one-step anesthetic buffering carpule according to claim 8. Peuke discloses further wherein the puncture unit (13) is actuated on the generally larger cylindrical first end (30, Annotated Fig 1) ([0043]: “The activator member 13 is movable in a first direction (in the Figure from the right toward the left) to activate the syringe 10 by causing the first liquid 18 and the second liquid 19 to merge.”).
Regarding Claim 10, Peuke/Ang/Stepovich/Cheetham/Cheikh/Larson discloses the one-step anesthetic buffering carpule according to claim 9. Peuke discloses wherein the liquid anesthetic (18, from Peuke modified with the teaching of Stepovich, see modification of claim 1) is mixed with the buffer (19, from Peuke modified with the teaching of Stepovich, see modification of claim 1) after the puncture unit is actuated ([0043]) ([0013]).
Response to Arguments
Applicant’s arguments with respect to claims 1-11, and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, Ogle (US 3303846 A).
Ogle teaches a device (Fig 3) comprising an activator (open ended cylinder 364A) comprising a soft rubber plug (floating pressure member 45 in the form of a rubber plug; Col 2, lines 67-68) positioned in an open interior portion (2001, Annotated Fig 2) of the knob (2002, Annotated Fig 2).
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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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783