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 9-14, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sefi (US 20110238038 A1) in view of Sam et al. (GB 2556903 A) in further view of Sperry et al. (US 20170303940 A1).
Regarding Claim 9, Sefi discloses an apparatus (Fig 11A) to facilitate directed delivery of a medicament ([0098]-[0099]) into a human organ (skin, [0001]) of a patient, the apparatus comprising: a container (Container 1000, Annotated Fig 1) for the medicament ([0098]-[0099]) fluidly connected to a needle (12; Fig 11A ,[0094]: “The combined structure of adapters 112 and 113 provides an interface as shown in FIG. 11C, which is functionally equivalent to the embodiments for FIGS. 1A-8B, suitable for use with a syringe 111 or other device.”, [0099]), the needle (12) comprising a needle shaft (shaft 1001, Annotated Fig 1) and a sharp distalmost tip (penetrating tip 12a, Fig 11C) with a bevel (bevel 1003, Annotated Fig 2; [0065]), wherein the needle (12) is connected to a distal end (distal end of container 1004, Annotated Fig 1) of the container (1000), and an adaptor (adapter 113, Fig 11A) including a proximal surface (1009, Annotated Fig 3), a distal surface (1017, Annotated Fig 3), and an outermost slanted surface (18, Fig 11C), the adaptor surrounding a portion (portion of needle covered by adapter 113, Fig 11C) of the needle shaft (1001, Annotated Fig 1) along its longitudinal axis (longitudinal axis 1005, Annotated Fig 1), and the needle shaft (1001, Annotated Fig 1) intersecting one or both of the distal surface and the outermost slanted surface (18),
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wherein a position of the adaptor (113) and the outermost slanted surface (18) are collectively configured to direct a trajectory of the sharp distalmost tip (12a) (skin contact surface 18 constrains movement of adapter 113 at a shallow angle when in contact to the skin; [0060]-[0061]) to a pre-determined depth ([0063]; length 1007 of penetrating portion 12a, pre-determined by penetration limiter 16 and contact edge 16a, which is a shared corner between limiter 16 and distal end of contact surface 18 , See Fig 11B) and location within the human organ (angle and depth of the injection determine the location inside the skin),wherein the outermost slanted surface (18) faces an identical direction (direction 1006, Annotated Fig 2) as the bevel (1003) of the sharp distalmost tip (12a), wherein an angle (shallow angle, [0060]) of the outermost slanted surface (18) dictates the trajectory of the needle (12) ([0061]), and wherein the length (length 1007, annotated Fig 2) of the needle (12) extending from the outermost slanted surface (18) determines the depth and location of the medicament delivery (angle and length 1007 of 12a determine location inside the skin).
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Sefi is silent regarding the adaptor being selectively translatable along the longitudinal axis to a plurality of positions and the needle shaft intersecting the proximal surface; and a fastener selectively adjustable between a first configuration in which the fastener allows selective translation of the adaptor to the plurality of positions and a second configuration in which the fastener prevents the adaptor from translating to set and maintain a length of the needle extending from the outermost slanted surface.
Sam et al. (GB 2556903 A) teaches an adaptor (positioning device 10, Fig 2) including a proximal surface (3000, Annotated Figs. 6-7), a distal surface (3001, Annotated Fig 6), and an outermost slanted surface (3002, Annotated Fig 6), the adaptor (10) configured to surround a portion of a needle shaft (needle shaft 22,Fig 1F) along its longitudinal axis (3003, Annotated Fig 6) such that the needle shaft (22) intersects the proximal surface (Annotated Figs. 6-7) and one or both of the distal surface (Fig 1F) and the outermost slanted surface (Fig 1B and 1F shows passive and retractive positions showing the intersection (note: intersection is being interpreted as passing through) of the proximal and distal surfaces); the adaptor (10) being selectively translatable along the longitudinal axis to a plurality of positions (first and second position; Page 3 1st Paragraph: “The sheath may be moveable between a first position in which, in use, the sheath covers the tip of the hypodermic needle and a second position in which, in use, a defined length of hypodermic needle is exposed.” )(Page 3, 2nd paragraph; Page 6, 3rd paragraph: “The positioning device thus allows both the angle of injection and the penetration depth to be controlled.”)
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the proximal end adapter of device of Sefi with a similar configurable adapter structure as taught by Sam for the purpose of controlling angle and penetration depth (Page 3, 2nd paragraph; Page 6, 3rd paragraph)
Sefi/Sam are silent regarding a fastener selectively adjustable between a first configuration in which the fastener allows selective translation of the adaptor to the plurality of positions and a second configuration in which the fastener prevents the adaptor from translating to set and maintain a length of the needle extending from the outermost slanted surface.
Sperry teaches an apparatus (percutaneous nephrolithotomy (PCNL) needle; example 22) comprising an adaptor (adjustable depth stop; example 22, [0127]) coupled the needle shaft via a fastener or screw(screw; [0132]); the fastener (screw; [0132]) selectively adjustable between a first configuration in which the fastener allows selective translation of the adaptor to the plurality of positions and a second configuration in which the fastener prevents the adaptor from translating to set and maintain a length of the needle extending from the outermost surface ([0132]: “a threaded fastener disposed within the threaded aperture, the threaded fastener movable between a position in which the threaded fastener frictionally engages the PCNL needle shaft and limits movement of the adjustable depth stop relative to the PCNL needle shaft and a position in which the threaded fastener does not frictionally engage the PCNL needle shaft.”).
Sefi/Sam/Sperry as modified discloses second configuration ([0132] from Sperry) in which the fastener prevents the adaptor from translating to set and maintain a length of the needle ([0132] from Sperry) extending from the outermost surface (18, from Sefi).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the coupling of adapter of Sefi/Sam with a screwed coupling as taught by Sperry to adjust the depth of the injection at the desired distance ([0127]; [0129]; [0132]).
Regarding claim 10, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses wherein the sharp distalmost tip (12a) is a portion of the needle (12) extending from a distal surface (surface of penetration limiter 16, Fig 11C) of the adaptor (113) (Fig 11C).
Regarding claim 11, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses further comprising a needle hub shaft (adapter 112, Fig 11A) connected to a proximal end (1007 proximal end of the needle, Annotated Fig 1) of the needle (12), such as a staked needle.
Regarding claim 12, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses wherein the angle (shallow angle, [0060]) ranges from about 25 degrees to about 75 degrees. ([0068): “Reference is made herein to a “shallow angle”. The term “shallow angle” is used herein to refer to a direction which forms a sharp angle with the relevant reference plane, i.e., no more than 45 degrees”
Regarding claim 13, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses wherein the angle (shallow angle, [0060]) ranges from about 40 degrees to about 60 degrees. ([0068): “Reference is made herein to a “shallow angle”. The term “shallow angle” is used herein to refer to a direction which forms a sharp angle with the relevant reference plane, i.e., no more than 45 degrees”
Regarding claim 14, Sefi/Sam/Sperry discloses the apparatus of claim 9.Sefi/Sam are silent wherein the adaptor is connected to a portion of the needle shaft via a fastener or screw.
Sperry discloses an apparatus (percutaneous nephrolithotomy (PCNL) needle; example 22) comprising an adaptor (adjustable depth stop; example 22, [0127]) coupled the needle shaft via a fastener or screw ([0132]: “a threaded fastener disposed within the threaded aperture, the threaded fastener movable between a position in which the threaded fastener frictionally engages the PCNL needle shaft and limits movement of the adjustable depth stop relative to the PCNL needle shaft and a position in which the threaded fastener does not frictionally engage the PCNL needle shaft.”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the coupling of adapter of Sefi/Sam with a screwed coupling as taught by Sperry to adjust the depth of the injection at the desired distance ([0127]; [0129]; [0132]).
Regarding claim 16, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses wherein the proximal surface (1009, Annotated Fig 9) extends in a first plane (1010, Annotated Fig 2) perpendicular to the needle (Annotated Fig 3) and the distal surface (surface of penetration limiter 16, Fig 11C) extends in a second plane (1013, Annotated Fig 3) parallel to the first plane (1010, Annotated Fig 3), wherein the adaptor (113) further includes an angled distal side (skin contact surface 18, Fig 11B); and an intermediate surface (1011) extending between the proximal surface (1009) and the angled distal side (18), wherein the intermediate surface (1011) extends in a third plane (1012, Annotated Fig 3) perpendicular to the first plane (1010).
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Regarding claim 17, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses wherein the outermost slanted surface (18) is angled (1015, Annotated Fig 4) relative to a longitudinal axis (1016, Annotated Fig 4) of the adaptor (113).
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Regarding claim 18, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi discloses the outermost slanted surface (18) wherein the outermost surface (18) is configured to mate with an outer surface of an eye (slanted surface 18 of Sefi is structurally capable to mate with an outer surface of the eye).
Claims 36 is rejected under 35 U.S.C. 103 as being unpatentable over Sefi (US 20110238038 A1) in view of Sam et al. (GB 2556903 A) in further view of Sperry et al. (US 20170303940 A1) in further view of Andino et al. (US 20150038905 A1).
Regarding claim 36, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi is silent wherein the needle is replaceable.
Andino teaches wherein the needle is replaceable ([0333]: “(…)replacement needles and/or hubs”; the presence of replacement needles and/or hubs indicate that the needle can be replaced). Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to configure the device of Sefi/Sam to be able of needle replacement as taught by Andino to facilitate delivery of the medicament to the target tissue ([0333]).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Sefi (US 20110238038 A1) in view of Sam et al. (GB 2556903 A) in further view of Sperry et al. (US 20170303940 A1) in further view of Touchard et al. (US 20110152749 A1).
Regarding claim 37, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi is silent wherein, when the adaptor is in at least one of the plurality of positions, the sharp distalmost tip extends between 600 μm and 800 μm from the distal surface.
Sperry teaches the adaptor is in at least one of the plurality of positions ([0132]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the coupling of adapter of Sefi/Sam/Sperry with a screwed coupling as taught by Sperry to adjust the depth of the injection at the desired distance ([0127]; [0129]; [0132]).
Sefi/Sam/Sperry are silent regarding the sharp distalmost tip extends between 600 μm and 800 μm from the distal surface.
Touchard teaches an apparatus (injection device, Fig 1-4) comprising a sharp distalmost tip (distal end 17.sub.1; Fig 4) extends between 600 μm and 800 μm from the distal surface (cover 52 of abutment face 40)([0225]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sefi/Sam/Sperry with an injection depth slightly above 700 μm as taught by Touchard for the purpose of increase effectivity of the injection of ciliary muscle ([0225])
Regarding claim 38, Sefi/Sam/Sperry discloses the apparatus of claim 9. Sefi is silent wherein, when the adaptor is in at least one of the plurality of positions, the sharp distalmost tip extends approximately 700 μm from the distal surface.
Sperry teaches the adaptor is in at least one of the plurality of positions ([0132]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the coupling of adapter of Sefi/Sam/Sperry with a screwed coupling as taught by Sperry to adjust the depth of the injection at the desired distance ([0127]; [0129]; [0132]).
Sefi/Sam/Sperry are silent regarding the sharp distalmost tip extends approximately 700 pm from the distal surface.
Touchard teaches an apparatus (injection device, Fig 1-4) comprising a sharp distalmost tip (distal end 17.sub.1; Fig 4) extends between 600 μm and 800 μm from the distal surface (cover 52 of abutment face 40)([0225]; ).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sefi/Sam with an injection depth slightly above, but approximate to 700 μm as taught by Touchard for the purpose of increase effectivity of the injection of ciliary muscle ([0225]).
Claims 29-30, 34-35, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Andino et al. (US 20150038905 A1) in view of Sperry et al. (US 20170303940 A1) in further view of Sam et al. (GB 2556903 A).
Regarding Claim 29, Andino discloses an apparatus (medical injector 28000, Fig 89A-B) to facilitate directed delivery of a medicament (abstract) into a human organ (eye, [0323]) of a patient, the apparatus comprising: a container for the medicament (medicament container 28310, Fig 89A-B) fluidly connected to a needle (needle 28240, Fig 89A-B) ([0323]), the needle (28240) comprising a needle shaft (shaft 2000, Annotated Fig 5) and a sharp distalmost tip (sharp tip 2001, Annotated Fig 5) with a bevel (bevel 2002, Annotated Fig 5), and an adaptor (adjustment member 28230, Fig 89A-B) surrounding a portion (2003, Annotated Fig 5) of the needle shaft (Fig 89A-B) along its longitudinal axis (2005, Annotated Fig 5), the portion (2003, Annotated Fig 5) not including the sharp distalmost tip (2001, Annotated Fig 5) of the needle (28240), the adaptor (28230) including an outermost slanted surface (2004, Annotated Fig 5) configured to direct a trajectory of the sharp distalmost tip (2001, Annotated Fig 5) to a pre-determined depth and location within the human organ (eye; [0323]: “adjustment member 28230 defines a curved surface, which can be configured to conform the curved surface of a target tissue, for example, an eye. The movement of the adjustment member 28230 can be used to adjust a distance that a distal tip of the needle 28240 can be inserted into the target tissue, for example, ocular tissue.”), wherein the adaptor (28230) is coupled to the needle shaft (2000) such that the adaptor (28230) is selectively translatable along the longitudinal axis (2005, Annotated Fig 5) to define the pre- determined depth and location ([0323]: “The adjustment member 28230 can be slideably disposed about the needle 28240 and be configured to be movable between a first position A and a second position B.”), wherein the outermost slanted surface (2004, Annotated Fig 5) is configured to be placed against an outer surface of the human organ (eye) of the patient ([0323])
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Andino is silent wherein the adaptor is coupled to the needle shaft via a screw; wherein the screw is selectively adjustable between a first configuration in which the screw allows selective translation of the adaptor to a plurality of positions and a second configuration in which the screw prevents the adaptor from translating to set and maintain a length of the needle extending from the outermost slanted surface, and the outermost slanted surface is angled in a range from 40 degrees to 60 degrees relative to the longitudinal axis of the needle shaft.
Sperry discloses an apparatus (percutaneous nephrolithotomy (PCNL) needle; example 22) comprising an adaptor (adjustable depth stop; example 22, [0127]) coupled the needle shaft via a fastener or screw ([0132]); wherein the screw is selectively adjustable between a first configuration in which the screw allows selective translation of the adaptor to a plurality of positions and a second configuration in which the screw prevents the adaptor from translating to set and maintain a length of the needle extending from the slanted surface ([0132]: “a threaded fastener disposed within the threaded aperture, the threaded fastener movable between a position in which the threaded fastener frictionally engages the PCNL needle shaft and limits movement of the adjustable depth stop relative to the PCNL needle shaft and a position in which the threaded fastener does not frictionally engage the PCNL needle shaft.”)
Andino/Sperry as modified discloses second configuration ([0132] from Sperry) in which the fastener prevents the adaptor from translating to set and maintain a length of the needle ([0132] from Sperry) extending from the outermost surface (2004, Annotated Fig 5, from Andino).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the coupling of adapter of Andino with a screwed coupling as taught by Sperry to adjust the depth of the injection at the desired distance ([0127]; [0129]; [0132]).
Andino/Sperry are silent regarding the outermost slanted surface is angled in a range from 40 degrees to 60 degrees relative to the longitudinal axis of the needle shaft.
Sam teaches an adaptor (positioning device 10, Fig 2) including a proximal surface (3000, Annotated Fig 6), a distal surface (3001, Annotated Fig 6), and an outermost slanted surface (3002, Annotated Fig 6), the outermost slanted surface (3002, Annotated Fig 6) is angled in a range from 40 degrees to 60 degrees relative to the longitudinal axis (3003, Annotated Fig 6) of the needle shaft (22) (Page 2, 3rd paragraph: “The contact surface may have a substantially planar surface. A substantially planar surface is includes a surface with a slight curve but which in use acts as a planar surface by lying flat on a surface. The angle between the planar surface and the longitudinal axis may be in the range of 30° to 90°.”; claim 3)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the distal end of adapter of device of Andino/Sperry with a similar shape as taught by Sam for the purpose of controlling angle of penetration (Page 3, 2nd paragraph; Page 6, 3rd paragraph) (background).
Regarding Claim 30, Andino/Sperry/Sam discloses the apparatus of claim 29. Andino discloses wherein the outermost slanted surface (2004, Annotated Fig 5) is configured to mate with the outer surface of an eye (Outermost slanted surface of device of Andino/Sperry/Sam is structurally capable of mating surface of the eye; [0323]: “The movement of the adjustment member 28230 can be used to adjust a distance that a distal tip of the needle 28240 can be inserted into the target tissue, for example, ocular tissue.”).
Regarding Claim 34, Andino/Sperry/Sam discloses the apparatus of claim 29. Andino discloses wherein a distal end (end represented by position A, Fig 89A) of the adaptor (28230) is offset a first distance from the sharp distalmost tip (2001) (distance from tip 2001 to position A) and the pre- determined depth is defined by the first distance ([0323]; depth of injection is defined by position A or B).
Regarding Claim 35, Andino/Sperry/Sam discloses the apparatus of claim 29. Andino discloses wherein the container (28310) includes an ophthalmic drug ([0112]).
Regarding Claim 39, Andino/Sperry/Sam discloses the apparatus of claim 29. Andino discloses wherein the needle is replaceable ([0333]: “(…)replacement needles and/or hubs”; the presence of replacement needles and/or hubs indicate that the needle can be replaced).
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive. Applicant submits that Andino and Sam both teach devices in which the alleged adaptor is intended to move upon insertion of the needle and modifying either device to incorporate Sperry’s threaded fastener would render the device non-functional.
Examiner respectfully disagrees the proposed modification does not render Andino device non-functional. The modified device would continue to perform its intended function. The overall function of both mechanisms is the adjusting the injection depth. Implementation of a screw adjustment mechanism into the device of Andino would not hinder the overall depth adjusting function. Modification would achieve predictable results; it would provide the user with increase flexibility of options related to adjust the depth to a desired length ([0132] from Sperry).
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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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
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