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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17, 19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire et al. (US 20150065916 A1).
Regarding claim 17, Maguire discloses an injection system (Fig 1A) for automatically injecting a needle (13), the injection system comprising: a housing (4, Fig 1A); an injection mechanism (5+15+16+ processors 19-20,22-23) comprising: a securing element (5, Fig 3B) for securing a needle element (needle device carrier 12+ needle 13, Fig 3C) (Fig 3B-3C) comprising the needle (13) ; a positioning element (servo motor 15, Fig 3B) for positioning the needle element (12+13) along a first axis (Y axis, Annotated Fig 1 defining left and right movement, Fig 3B); and an insertion element (servo motor 16, Fig 3B) for inserting the needle element (13) along a perpendicular second axis (Z axis; defining up/down movement) ([0105]); and a set of one or more processors (processors 19, 20, 22, 23; [0103], Fig 3A) configured to: identify an injection position ([0103]: “processor 19 (FIG. 3A) is provided for calculating a relative needle target puncture position”) using a first set of one or more sensors (sensors that create the 3D volumetric image; [0103]); position an injection mechanism (5+15+16+19-20,22-23) at the identified injection position along the first axis (Y) ([0103]; processor 19, 20, and 22 work together to position the injection mechanism); and insert the needle (13) along the perpendicular second axis (Z) until entry in a vein is detected using a second set of one or more sensors (force sensor;[0099]).
Regarding claim 19, Maguire discloses the injection system of claim 17, wherein the needle element (12+13, Fig 3C) comprises a coupling assembly (needle device carrier 12, Fig 3B) for connecting the needle (13) to the injection mechanism (5+15+16+ processors 19-20,22-23), wherein the coupling assembly (12) provides a connection (1001, Annotated Fig 2; connection through needle 13 hub to proximal connector of carrier 12) for liquids (fluids, Claim 3) passing through the needle (13) , wherein the connection is perpendicular to the needle (13) (connection extends in a direction along the Y axis which is perpendicular to the needle).
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Regarding claim 21, Maguire discloses the injection system of claim 19, the needle element (12+13+14) further comprises a needle housing (device carrier housing 14, Fig 3C) that surrounds the needle (13), wherein the needle housing (14) comprises a locking mechanism (locking mechanism provided by servo motors ; [0105]), wherein the set of processors (19-20+22-23) is further configured to lock the locking mechanism when a vein is detected ([0118]; motor stop is being interpreted as locking at the designated position once the absolute target position and the displacement coincide).
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.
Claims 1-5, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Chawki et al. (US 20070161953 A1).
Regarding claim 1, Maguire discloses a method for automatically injecting a needle (13) into a vein, the method comprising: identifying an injection position ([0103]: “processor 19 (FIG. 3A) is provided for calculating a relative needle target puncture position”) using a first set of one or more sensors (sensors that create the 3D volumetric image; [0103]); positioning an injection mechanism (5+15+16+19-20,22-23) at the identified injection position ([0103]); Maguire discloses inserting the needle (13)([0015]) until entry in a vein is detected using a second set of one or more sensors (force sensor;[0099]).
Maguire is silent regarding inserting the needle (13) ([0015]) in a direction perpendicular to a skin surface.
Chawki teaches inserting the needle in a direction perpendicular to a skin surface ([0080]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire to include a direction perpendicular to the skin as taught by Chawki for the purpose of reducing the vessel wall trauma during the repeated puncture procedures ([0080]).
Regarding claim 2, Maguire/Chawki discloses the method of claim 1. Maguire discloses wherein the first set of sensors comprises at least one of the group consisting of an infrared sensor ([0089]), an optical sensor ([0014]), and ultrasound ([0077]).
Regarding claim 3, Maguire/Chawki discloses the method of claim 1. Maguire discloses wherein positioning the injection mechanism comprises moving the injection mechanism along a first axis (Y) and vertically inserting the needle comprises moving the injection mechanism along a second perpendicular axis (Z) (Annotated Fig 1; [0105]).
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Regarding claim 4, Maguire/Chawki discloses the method of claim 1. Maguire discloses further comprising securing a depth of the injection mechanism when entry in the vein is detected ([0116]).
Regarding claim 5, Maguire/Chawki discloses the method of claim 4. Maguire discloses wherein: the needle (13) is part of a needle element (13+12+14), the needle element comprises a needle housing (14), and securing the depth of the injection mechanism (5+15+16+19-20,22-23) comprises locking a position of the needle housing (14).
Regarding claim 13, Maguire/Chawki discloses the method of claim 1. Maguire discloses wherein vertically inserting the needle (13) comprises rotating the needle (13) around an axis of the needle (13) (needle 13 is rotated around its axis when being vertically inserted into device carrier 12 and then into the vein; Fig 3B-C).
Regarding claim 16, Maguire/Chawki discloses the method of claim 1. Maguire discloses further comprising generating a 2-D map using the first set of sensors and identifying the injection position based on the generated 2-D map ([0097]-[0098]; 3D mapping creates 2D projections when the mapping is being performed; injection position is being determined based on the mapping).
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Chawki et al. (US 20070161953 A1) in further view of Paassilta et al. (US 20100286507 A1) in further view of Schwartz et al (US 20050197633 A1).
Regarding claim 7, Maguire/Chawki discloses the method of claim 1. Maguire discloses wherein: the second set of sensors comprises at least one of the group consisting of a force sensor (force sensor; [0099]), an electrochemical impedance sensor, a light sensor, and an ultrasound sensor and detecting entry in the vein ([0099]).
Maguire is silent wherein the second set of sensors comprises first and second electrochemical impedance sensors; detecting a presence of a liquid at both the first and second electrochemical impedance sensors; and a set of lumen holes of the needle are located between the first and second electrochemical impedance sensors.
Paassilta teaches a set of sensors (electrodes 16, 18, 21, 22, Fig 5) comprises first (electrode 16, Fig 5) and second electrochemical impedance sensors (electrode 18, Fig 5); detecting entry in the vein comprises detecting a presence of a liquid (fluid in tissue) at both the first (16) and second electrochemical impedance sensors (18) (abstract).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire/Chawki with similar electrode positions as taught by Paassilta for the purpose of detecting the position of the injection needle ([0084-0086]).
Maguire/Chawki/Paassilta are silent wherein a set of lumen holes of the needle are located between the first and second electrochemical impedance sensors.
Schwartz teaches a method wherein a set of lumen holes (end holes 68, Fig 13)of the needle are located between the first and second electrochemical impedance sensors ([0075]: first electrode at the needle tip and a second electrode spaced apart; additional electrodes could be used to determine the depth of the injection which would include a greater distance than the tip of the needle; holes 68 will lie between the first and second electrode; Fig 13).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, as taught by Schwartz while maintaining the electrodes position Maguire/Chawki/Paassilta for the purpose of adjusting the flow rate of the injection to a desired value base on the selected diameter of the holes (Abstract: “create a desired injectate cloud pattern when an injectate is forced through the central lumen and through the plurality of holes”).
Claims 6 and 10 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Chawki et al. (US 20070161953 A1) in view of Peters (US 20060129184 A1).
Regarding claim 6, Maguire/Chawki discloses the method of claim 1. Maguire is silent regarding further comprising positioning a set of one or more vein roll prevention bars around the injection position.
Peters discloses at least two roll prevention bars (tabs 20, 22, Fig 1) around the injection opening (Fig 1-2).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Maguire/Chawki with similar roll prevention bars around the injection as taught by Peters for the purpose of stabilizing the veins (abstract).
Regarding claim 10, Maguire/Chawki discloses the method of claim 1 further. Maguire is silent regarding comprising a pressurized space around the injection position; and sterilizing the pressurized space around the injection position.
Peters discloses at least two roll prevention bars (tabs 20, 22, Fig 1) placed in parallel along the injection opening (Fig 1-2); a pressurized space around the injection position ([0009]: “compression of the skin immediately proximate to the vein”); and sterilizing the pressurized space around the injection position ([0026]; Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire/Chawki with similar roll prevention bars and sterilization of the injection area as taught by Peters for the purpose of stabilizing the veins (abstract) and prevent infection ([0026]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Chawki et al. (US 20070161953 A1) in view of Niven et al. (US 20180243506 A1).
Regarding claim 12, Maguire/Chawki discloses the method of claim 1. Maguire discloses wherein inserting a needle comprises: advancing the needle (13) into a user; and when entry in the vein is detected, locking the needle housing (14) (when needle entry is detected motor 16 within housing 14 is halted so that it does not further displace the needle 13; claim 16; [0026]; [0106]).
Maguire is silent regarding inserting the needle in a direction perpendicular to a skin surface causing a needle housing surrounding the needle to retract and locking of the needle housing so that it cannot retract further.
Chawki teaches inserting the needle in a direction perpendicular to a skin surface ([0080]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire to include a direction perpendicular to the skin as taught by Chawki for the purpose of reducing the vessel wall trauma during the repeated puncture procedures ([0080]).
Maguire/Chawki are silent regarding causing a needle housing surrounding the needle to retract and locking of the needle housing so that it cannot retract further.
Niven teaches a method of inserting a needle (needle 116, Fig 1) comprises advancing a needle (116) into a user causing a needle housing (needle-cover 128, Fig 1) surrounding the needle (116) to retract ([0026];[0029] needle cover reciprocates due to springs 140; when inserted it retracts against biasing force of the springs; claim 1; Fig 1 ).
Maguire/Chawki/Niven discloses when entry in the vein is detected, locking the needle housing so that it cannot retract further (Maguire needle housing as modified with Niven teaching cannot further retract once vein is detected by sensors of Maguire and the motor 16 withing housing are halted).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the needle housing of method of Maguire/Chawki to surround the needle and have similar springs as taught by Niven to maintain sterility of the needle prior to use (claim 17).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Chawki et al. (US 20070161953 A1) in view of Bagwell et al. (US 20170080166 A1).
Regarding claim 14, Maguire/Chawki discloses the method of claim 1. Maguire discloses wherein detecting entry in the vein comprises determining a force measurement (force sensor; [0099]) and vertically inserting the needle (needle is being inserted in the vertical direction; [0015]).
Maguire is silent regarding oscillating the needle, wherein the force measurement is based on an oscillation frequency of the oscillation.
Bagwell teaches a method comprising an oscillating the needle (needle 10, Fig 1) ([0049]; needle vibrates by using a vibrational actuator 62); wherein a force measurement is based on an oscillation frequency of the oscillation ([0077]; [0082]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire/Chawki with similar vibrational actuator as taught by Bagwell to overcome the tissue deformation and vein rolling complications typically encountered in needle insertion and as to reduce the force necessary for puncturing and sliding through tissue, thereby improving insertion control ([0049]; [0082])
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Peters (US 20060129184 A1).
Regarding claim 18, Maguire discloses the injection system of claim 17, wherein: the housing (4) comprises an injection opening (1000, Annotated Fig 1). Maguire is silent regarding at least two roll prevention bars placed in parallel along the injection opening.
Peters discloses at least two roll prevention bars (tabs 20, 22, Fig 1) placed in parallel along the injection opening (Fig 1-2).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Maguire with similar roll prevention bars as taught by Peters for the purpose of stabilizing the veins (abstract).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Niven et al. (US 20180243506 A1) in further view of Welch (US 3677245 A).
Regarding claim 23, Maguire discloses the injection system of claim 21, wherein the needle housing is a retractable needle housing that comprises a sheath that covers an opening of the needle housing.
Niven teaches a method wherein a needle housing (needle-cover 128, Fig 1) is a retractable needle housing ([0026]; [0029] needle cover reciprocates due to springs 140; when inserted it retracts against biasing force of the springs; claim 1; Fig 1)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the needle housing of method of Maguire to surround the needle as taught by Niven to maintain sterility of the needle prior to use (claim 17).
Maguire/Niven are silent wherein that comprises a sheath that covers an opening of the needle housing.
Welch teaches a method comprising a sheath (Sealing means 25, Fig 1) that covers an opening of the needle housing (needle shield 24, Fig1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire/Niven with similar sealing means as taught by Welch to keep the interior of the needle housing sterile (Col 4, lines 19-44).
Claims 25 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Paassilta et al. (US 20100286507 A1).
Regarding claim 25, Maguire discloses the injection system of claim 19, wherein the needle comprises a first electrochemical sensor below a lumen opening of the needle and a second electrochemical sensor above the lumen opening.
Paassilta teaches an injection system (Fig 1) wherein the needle comprises a first electrochemical sensor (electrode 18, Fig 5) below a lumen opening (lumen opening of needle 2, Fig 5) of the needle (2) and a second electrochemical sensor (electrode 16, Fig 5) above the lumen opening (lumen opening of needle 2, Fig 5).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Maguire with similar electrode positions as taught by Paassilta for the purpose of detecting the position of the injection needle ([0084-0086]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US 20150065916 A1) in view of Leeflang et al. (US 20170119956 A1).
Regarding claim 26 Maguire discloses the injection system of claim 17, wherein the needle tip is a non-linear tip.
Leeflang teaches an injection system (Fig 1) comprising a needle tip wherein the needle tip is a non-linear tip (a non-linear needle tip; [0091]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Maguire with a similar non-linear tip as taught by Leeflang for the purpose of distribute an infusate over a longer length than is possible compared to a straight needle ([0091]).
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 10, 12-14, 16-19, 21, 23, and 25-26 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.
In regards to claim 17, applicant submits that Maguire et al. (US 20150065916 A1) do not disclose that device injects a patient in a direction perpendicular to the skin.
Examiner respectfully disagrees.
Claim 17 does not require the injection to be perpendicular to the skin. It requires injection along a perpendicular axis, but the axis is not limited to be perpendicular to the skin.
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 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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
