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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “156” has been used to designate both “longitudinal ridges or fins” in Figures 4A-4F and “injector cannula” in Figures 5A-5B. 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. 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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied: “Injector devices and methods for using them to deliver medicament into a patient's body, e.g., sub-retinally within an eye, are provided” (emphasis added). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
There appears to be a typo regarding “the injector cannula 110” as opposed to “the injector cannula 110” on page 17, line 16
There appears to be a typo regarding “the groove 180” as opposed to “the groove 182” on page 23, line 4 and line 18 (two instances).
There appears to be a typo regarding “the valve 124 of a trocar valve 122” as opposed to “the valve
There appears to be a typo regarding “the trocar cannula 124” as opposed to “the trocar cannula 122” on page 30, line 9
There appears to be a typo regarding “the hypodermic bevel 256” as opposed to “the hypodermic bevel 258” on page 31, line 20
Appropriate correction is required.
Claim Objections
Claim 17 is objected to because of the following informalities: there is a lack of antecedent basis for “the injector fitting interface” in line 2 as opposed to “the fitting interface”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: there is a lack of antecedent basis for “the snaps” in line 3 as opposed to “the one or more snaps”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 5-9 and 14-19 are 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.
Regarding claims 5-9 and 14-19, the preamble of each claim of “The injector cannula of claim…” renders the claims indefinite. There is a lack of antecedent basis for “The injector cannula” in each of the claims. Claims 5-9 are dependent on claim 1, which is directed to “An injector device”. Similarly, claims 14-19 are dependent upon claim 11, which is also directed to “An injector device”. It is suggested to amend the preamble of each of claims 5-9 and 14-19 to “The injector device of claim…”.
Claim 10 recites the limitation "the injector fitting" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the injector cannula comprises both an elongate tubular member and an injector fitting, or only one of those two structures. For examination purposes, the examiner has interpreted “the injector fitting” to be the same structure as “the elongate tubular member”. It is suggested to amend line 6 to “…a distal end extending distally from thetubular member;”.
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 1-2, 4-6, 9-12, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 20170216092) in view of Scheller et al. (US 20130197488).
Regarding claim 1, Singh discloses an injector device (cannula device 600) for delivering a medicament into a patient's body (“injection of a therapeutic agent from the internal fluid chamber 631 to the eye 642.” [0049]), comprising:
a housing (internal fluid chamber 631) containing the medicament and including an outlet end for delivering the medicament from the housing (Figure 10; “the internal fluid chamber 631 may be releasably connected to the handle 602 and/or the inner sleeve 608. The internal fluid chamber 631 and the inner sleeve 608 may be connected through a threaded connection, a press fit, a friction fit, a snap fit, a mechanical interlock, other selective connection mechanism, or combinations thereof.” [0050]);
an injector fitting (handle 602) comprising a first end coupled to the outlet end of the housing and a second end (Figure 10);
a flow cannula (shaft 604) comprising a proximal end attached to the second end of the injector fitting and a distal end extending distally from the injector fitting (Figure 10);
a injector tip (inner sleeve 608) extending distally from the distal end of the flow cannula (Figure 1, for example. Inner sleeve labeled 108);
a hub (control member 114, unlabeled in Figure 10) slidably coupled to the injector fitting (Figures 5-6 and 7-8, for example; “moving the control member 114 distally may move the outer sleeve 106 distally and moving the control member 114 proximally may move the outer sleeve 106 proximally.” [0033]); and
a tip protector tube (outer sleeve 106 having penetrative tip 110) permanently attached to and extending distally from the hub (“the control member 114 may be operably connected to the outer sleeve 106 by an adhesive, a mechanical connection (e.g., bolt, clamp, screw), a mechanical linkage, an integral connection (e.g., brazing, welding), or combinations thereof. In other embodiments, the control member 114 may be integrally formed with the outer sleeve 106” [0033]) and slidably disposed over the flow cannula (“The outer sleeve 106 may be longitudinally slidable relative to the shaft 104.” [0029]), the hub slidable on the injector fitting to cause the tip protector tube to slide relative to the flow cannula from an extended position (Figure 5 and 7, for example) in which the tip protector tube covers the entire injector tip (“The inner sleeve 108…may be covered by the outer sleeve 106 when the outer sleeve 106 is moved distally.” [0030]), and a retracted position (Figure 6 and 8, for example) in which the tip protector tube is retracted proximally relative to the injector tip thereby exposing at least part of the injector tip from the tip protector tube (“The inner sleeve 108 may protrude distally from the outer sleeve 106 when the outer sleeve 106 is moved proximally” [0030]).
Singh fails to explicitly disclose the injector tip is a flexible injector tip and the tip protector tube being substantially stiffer than the injector tip.
Scheller teaches an injector device (surgical instrument assembly 500) comprising an injector fitting (handle base 120); a flexible injector tip (inner sleeve 130; “a flexible microsurgical instrument tip …the flexible instrument tip” [0004]); a hub (piston 160); and a tip protector tube (support sleeve 540); wherein the tip protector tube being substantially stiffer than the injector tip (“support sleeve 540 may be configured to increase a stiffness of inner sleeve 130. In one or more embodiments, inner sleeve 130 may have a first stiffness and support sleeve 540 may have a second stiffness. Illustratively, the second stiffness may be greater than the first stiffness.” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the injector tip of Singh to be a flexible injector tip based on the teachings of Scheller to ensure the injector tip has the flexibility necessary to reach target area of the inner eye (Scheller [0030]) and to further modify the injector device of Singh to include the tip protector tube is substantially stiffer than the injector tip based on the teachings of Scheller to prevent the flexible injector tip from bending or flexing when the injector tip is located within the tip protector tube, protecting the injector tip and ensuring that the injector tip is actuated in a predictable manner (Scheller [0005], [0038]).
Regarding claim 2, modified Singh teaches the injector device of claim 1, wherein the outlet end and the injector fitting comprise connectors for removably coupling the injector fitting to the housing (“the internal fluid chamber 631 may be releasably connected to the handle 602 and/or the inner sleeve 608. The internal fluid chamber 631 and the inner sleeve 608 may be connected through a threaded connection, a press fit, a friction fit, a snap fit, a mechanical interlock, other selective connection mechanism, or combinations thereof.” [0050]).
Regarding claim 4, modified Singh teaches the injector device of claim 1, wherein the hub (control member 114) and the injector fitting (handle 602) have a sliding interface which rotationally aligns the hub and the injector fitting and prevents relative rotation of the hub and injector fitting (Figures 1 and 2).
Regarding claim 5, modified Singh teaches the injector cannula of claim 4, wherein the sliding interface comprises one or more longitudinal slots on one of the hub and the injector fitting (slot in handle 102/602 through which control member 114 extends; Figures 1-2 and 10) and one or more longitudinal ridges or fins on the other of the hub and the injector fitting (outward extending portion of control member 114; Figure 1-2 and 10), which are slidably received in respective slots of the one or more longitudinal slots (“a control member 114 protruding from and/or positioned in the handle 102” [0033]; Figures 1-2 and 10).
Regarding claim 6, modified Singh teaches the injector cannula of claim 1, further comprising a flange on a proximal end of the hub (portion of control member 114 extending outside of handle 102/602).
Regarding claim 9, modified Singh teaches the injector cannula of claim 1, wherein the injector device is one of a syringe (Figure 10, showing internal fluid chamber 631 having plunger 658 and therefore internal fluid chamber 631 is a syringe), and a self-powered injector.
Regarding claim 10, Singh discloses an injector cannula (cannula device 600) for delivering a medicament into a patient's body (“injection of a therapeutic agent from the internal fluid chamber 631 to the eye 642.” [0049]), comprising:
an elongated tubular member (handle 602) comprising a first end including a connector for coupling the injector cannula to an injector device (internal fluid chamber 631; “the internal fluid chamber 631 may be releasably connected to the handle 602 and/or the inner sleeve 608. The internal fluid chamber 631 and the inner sleeve 608 may be connected through a threaded connection, a press fit, a friction fit, a snap fit, a mechanical interlock, other selective connection mechanism, or combinations thereof.” [0050]) and a second end (Figure 10);
a flow cannula (shaft 604) comprising a proximal end attached to the second end of the tubular member and a distal end extending distally from the injector fitting [tubular member, see rejection under 35 USC 112 above] (Figure 10);
a injector tip (inner sleeve 608) extending distally from the distal end of the flow cannula (Figure 1, for example. Inner sleeve labeled 108);
a hub (control member 114, unlabeled in Figure 10) slidably coupled to the tubular member (Figures 5-6 and 7-8, for example; “moving the control member 114 distally may move the outer sleeve 106 distally and moving the control member 114 proximally may move the outer sleeve 106 proximally.” [0033]); and
a tip protector tube (outer sleeve 106 having penetrative tip 110) permanently attached to and extending distally from the hub (“the control member 114 may be operably connected to the outer sleeve 106 by an adhesive, a mechanical connection (e.g., bolt, clamp, screw), a mechanical linkage, an integral connection (e.g., brazing, welding), or combinations thereof. In other embodiments, the control member 114 may be integrally formed with the outer sleeve 106” [0033]) and slidably disposed over the flow cannula (“The outer sleeve 106 may be longitudinally slidable relative to the shaft 104.” [0029]), the hub slidable on the injector fitting to cause the tip protector tube to slide relative to the flow cannula from an extended position (Figure 5 and 7, for example) in which the tip protector tube covers the entire injector tip (“The inner sleeve 108…may be covered by the outer sleeve 106 when the outer sleeve 106 is moved distally.” [0030]), and a retracted position (Figure 6 and 8, for example) in which the tip protector tube is retracted proximally relative to the injector tip thereby exposing at least part of the injector tip from the tip protector tube (“The inner sleeve 108 may protrude distally from the outer sleeve 106 when the outer sleeve 106 is moved proximally” [0030]).
Singh fails to explicitly disclose the injector tip is a flexible injector tip and the tip protector tube being substantially stiffer than the injector tip.
Scheller teaches an injector cannula (surgical instrument assembly 500) comprising an elongate tubular member (handle base 120); a flexible injector tip (inner sleeve 130; “a flexible microsurgical instrument tip …the flexible instrument tip” [0004]); a hub (piston 160); and a tip protector tube (support sleeve 540); wherein the tip protector tube being substantially stiffer than the injector tip (“support sleeve 540 may be configured to increase a stiffness of inner sleeve 130. In one or more embodiments, inner sleeve 130 may have a first stiffness and support sleeve 540 may have a second stiffness. Illustratively, the second stiffness may be greater than the first stiffness.” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the injector tip of Singh to be a flexible injector tip based on the teachings of Scheller to ensure the injector tip has the flexibility necessary to reach target area of the inner eye (Scheller [0030]) and to further modify the injector cannula of Singh to include the tip protector tube is substantially stiffer than the injector tip based on the teachings of Scheller to prevent the flexible injector tip from bending or flexing when the injector tip is located within the tip protector tube, protecting the injector tip and ensuring that the injector tip is actuated in a predictable manner (Scheller [0005], [0038]).
Regarding claim 11, Singh discloses an injector device (cannula device 600) for delivering a medicament into a patient's body (“injection of a therapeutic agent from the internal fluid chamber 631 to the eye 642.” [0049]), comprising:
a housing (internal fluid chamber 631) containing the medicament (Figure 10);
an injector fitting (handle 602) comprising a first end coupled to the housing and a second end (Figure 10; “the internal fluid chamber 631 may be releasably connected to the handle 602 and/or the inner sleeve 608.” [0050]);
a flow cannula (shaft 604) comprising a proximal end attached to the second end of the injector fitting, a distal end extending distally from the injector fitting (Figure 10), and a lumen for delivering the medicament from the housing (“The cannula device 600 may have a fluid conduit 628, as described in relation to FIG. 4, that extends from a distal end of the cannula device 600 through at least part of the shaft 604 and handle 602 to the internal fluid chamber 631.” [0049]; Figure 10);
a injector tip (inner sleeve 608) extending distally from the distal end of the flow cannula (Figure 1, for example. Inner sleeve labeled 108);
a hub (control member 114, unlabeled in Figure 10) slidably disposed on the injector fitting (Figures 5-6 and 7-8, for example; “moving the control member 114 distally may move the outer sleeve 106 distally and moving the control member 114 proximally may move the outer sleeve 106 proximally.” [0033]); and
a tip protector tube (outer sleeve 106 having penetrative tip 110) permanently attached to the hub (“the control member 114 may be operably connected to the outer sleeve 106 by an adhesive, a mechanical connection (e.g., bolt, clamp, screw), a mechanical linkage, an integral connection (e.g., brazing, welding), or combinations thereof. In other embodiments, the control member 114 may be integrally formed with the outer sleeve 106” [0033]), the tip protector tube slidably on the flow cannula (“The outer sleeve 106 may be longitudinally slidable relative to the shaft 104.” [0029]) from an extended position (Figure 5 and 7, for example) in which the tip protector tube covers the entire injector tip (“The inner sleeve 108…may be covered by the outer sleeve 106 when the outer sleeve 106 is moved distally.” [0030]), and a retracted position (Figure 6 and 8, for example) in which the tip protector tube is retracted proximally relative to the injector tip, thereby exposing at least part of the injector tip from the tip protector tube (“The inner sleeve 108 may protrude distally from the outer sleeve 106 when the outer sleeve 106 is moved proximally” [0030]).
Singh fails to explicitly disclose the injector tip is a flexible injector tip and the tip protector tube being substantially stiffer than the injector tip.
Scheller teaches an injector device (surgical instrument assembly 500) comprising an injector fitting (handle base 120); a flexible injector tip (inner sleeve 130; “a flexible microsurgical instrument tip …the flexible instrument tip” [0004]); a hub (piston 160); and a tip protector tube (support sleeve 540); wherein the tip protector tube being substantially stiffer than the injector tip (“support sleeve 540 may be configured to increase a stiffness of inner sleeve 130. In one or more embodiments, inner sleeve 130 may have a first stiffness and support sleeve 540 may have a second stiffness. Illustratively, the second stiffness may be greater than the first stiffness.” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the injector tip of Singh to be a flexible injector tip based on the teachings of Scheller to ensure the injector tip has the flexibility necessary to reach target area of the inner eye (Scheller [0030]) and to further modify the injector device of Singh to include the tip protector tube is substantially stiffer than the injector tip based on the teachings of Scheller to prevent the flexible injector tip from bending or flexing when the injector tip is located within the tip protector tube, protecting the injector tip and ensuring that the injector tip is actuated in a predictable manner (Scheller [0005], [0038]).
Regarding claim 12, modified Singh teaches the injector device of claim 11, wherein the outlet end and the injector fitting comprise connectors for removably coupling the injector fitting to the housing (“the internal fluid chamber 631 may be releasably connected to the handle 602 and/or the inner sleeve 608. The internal fluid chamber 631 and the inner sleeve 608 may be connected through a threaded connection, a press fit, a friction fit, a snap fit, a mechanical interlock, other selective connection mechanism, or combinations thereof.” [0050]).
Regarding claim 14, modified Singh teaches the injector cannula of claim 11, the hub (control member 114) slidably disposed on the flow cannula such that retracting the hub proximally retracts the tip protector tube (“FIG. 8 depicts the retraction of the penetrative tip 410 of the cannula device 400 upon proximal movement of the control member 414 to a retracted position. The penetrative tip 410 may move proximally and uncover the inner sleeve 408” [0047]; See Figures 8 and 10).
Regarding claim 16, modified Singh teaches the injector cannula of claim 11, wherein the hub (control member 114) has a hub interface (extending portion of control member 114; Figure 1-2 and 10) and the injector fitting has a fitting interface (slot in handle 102/602 through which control member 114 extends; Figures 1-2 and 10) which mates with the hub interface (Figures 1-2) such that the hub interface and the injector interface secure the hub to the injector fitting in the retracted position of the tip protector tube (Figures 4, 5, and 8, for example; “moving the control member 114 proximally may move the outer sleeve 106 proximally. In other embodiments, the movement and/or position of the outer sleeve 106 may be biased by a biasing member. For example, the movement and/or position of the outer sleeve 106 may be biased by a spring, a magnet, a compressible gas, a roller mechanism, or other biasing member that applies a proximal force to the outer sleeve 106 to urge the outer sleeve 106 in the proximal direction.” [0033]).
Regarding claim 19, modified Singh teaches the injector device of claim 11, wherein the hub (control member 114) and the injector fitting (handle 602) have a sliding interface which rotationally aligns the hub and the injector fitting and prevents relative rotation of the hub and injector fitting (Figures 1 and 2).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 20170216092) in view of Scheller et al. (US 20130197488) as applied to claims 1 and 11 above, and further in view of Bley et al. (US 20200330269).
Regarding claim 3, modified Singh teaches the injector device of claim 2.
Modified Singh fails to explicitly disclose the connectors comprise mating Luer hubs.
Bley teaches an injector device (Figure 10) comprising a housing (“a syringe for delivery of the material to be administer” [0100]) including an outlet end (Figure 10) and an injector fitting (hollow barrel 13); wherein the outlet end and the injector fitting comprise connectors that are mating Luer hubs (Luer fitting 44) for removably coupling the injector fitting to the housing (Figure 1; “The proximal end of the flexible cannula 38 terminates in an interface such as a Luer fitting 44 to allow delivery of a material for administration through the flexible cannula 38.” [0059]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the connectors of the outlet end and the injector fitting of the injector device of Singh to be mating Luer hubs based on the teachings of Bley to allow for reliable fluid coupling between the housing and the injector fitting (Bley [0059-0060]; Figures 1 and 10).
Regarding claim 13, modified Singh teaches the injector device of claim 2.
Modified Singh fails to explicitly disclose the connectors comprise mating Luer hubs.
Bley teaches an injector device (Figure 10) comprising a housing (“a syringe for delivery of the material to be administer” [0100]) and an injector fitting (hollow barrel 13); wherein the housing and the injector fitting comprise connectors that are mating Luer hubs (Luer fitting 44) for removably coupling the injector fitting to the housing (Figure 1; “The proximal end of the flexible cannula 38 terminates in an interface such as a Luer fitting 44 to allow delivery of a material for administration through the flexible cannula 38.” [0059]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the connectors of the housing and the injector fitting of the injector device of Singh to be mating Luer hubs based on the teachings of Bley to allow for reliable fluid coupling between the housing and the injector fitting (Bley [0059-0060]; Figures 1 and 10).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 20170216092) in view of Scheller et al. (US 20130197488) as applied to claim 1 above, and further in view of Sinko et al. (USPN 5279590).
Regarding claims 7 and 8, modified Singh teaches the injector cannula of claim 1.
Modified Singh fails to explicitly teach wherein the hub and the injector fitting comprise features that retain the hub and tip protector tube separately in the extended position and the retracted position, respectively, as required by claim 7; and
wherein the features comprise one or more snaps on the hub and a plurality of notches spaced apart longitudinally on the injector fitting, the one or more snaps configured to interface with respective notches on the injector fitting to retain the hub and tip protector tube separately in the extended position and the retracted position, as required by claim 8.
Sinko teaches an injector device (Figure 1) comprising an injector fitting (hollow tubular housing 1) and a hub (tubular needle mount 10 having locking tab 20); wherein the hub and the injector fitting comprise features that retain the hub and tip protector tube separately in the extended position (Figure 1) and the retracted position (Figure 2), wherein the features comprise one or more snaps on the hub (locking tab 20) and a plurality of notches spaced apart longitudinally on the injector fitting (recesses 1b and 1c), the one or more snaps configured to interface with respective notches on the injector fitting to retain the hub separately in the extended position (“The spring 50 will obviously be compressed by the forward movement of the needle mount 10 in housing 1 to the operative position of the needle 15, and will be locked against such spring bias by engagement of the locking tab 20 with the forward recess 1b provided in the housing 1” [Col 7, lines 51-56]) and the retracted position (“the needle can be locked in this inoperative sealed position by rotation of the locking tab 20 into the rearward recess 1c of the housing 1.” [Col 7, lines 63-66]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the hub and injector fitting of Singh such that hte hub comprises snaps and the injector fitting comprises a plurality of notches based on the teachings of Sinko to enable the injector device to be utilized in either operative position without requiring the user to manual retain the hub in the desired position (Sinko [Col 7, lines 44-66]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 20170216092) in view of Scheller et al. (US 20130197488) as applied to claim 14 above, and further in view of Vaillancourt (USPN 6811545).
Regarding claim 15, modified Singh discloses the injector cannula of claim 14.
Modified Singh fails to explicitly teach an elastomeric seal disposed on the hub through which the flow cannula passes with a friction fit around the flow cannula.
Vaillancourt discloses an injector device (safety needle 10) comprising: an injector fitting (housing 11); a flow cannula (blunt hollow cannula 13); a hub (slider 15); and a tip protector tube (needle 14); further comprising an elastomeric seal disposed on the hub through which the flow cannula passes with a friction fit around the flow cannula (“Depending upon the thickness of the annular space between the inner diameter of the needle 14 and the outer diameter of the cannula 13, a seal may or may not be required at the exit end of the needle 14…Should a seal be required (not shown), a plastic ring may be attached to the slider 15 with a slight interference fit about the needle 14 to prevent leakage. Such a plastic ring may be made of a soft plastic, such as polyethylene. Other means may also include the use of an O-ring or an elastomeric wiper ring.” [Col 5, lines 32-42]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the injector device of Singh to include an elastomeric seal disposed on the hub through which the flow cannula passes with a friction fit around the flow cannula based on the teachings of Vaillancourt to prevent leakage through the flow cannula (Vaillancourt [Col 5, lines 32-42]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 20170216092) in view of Scheller et al. (US 20130197488) as applied to claim 16 above, and further in view of Kreamer (USPN 5370623).
Regarding claim 17, modified Singh teaches the injector cannula of claim 16.
Modified Singh fails to explicitly disclose the hub interface comprises a female tapered surface and the injector fitting interface comprises a male tapered surface.
Kreamer teaches an injector device (catheterization system 10) comprising an injector fitting (support member 14); a flow cannula (needle 18); and a hub (sheath 20) slidable disposed on the injector fitting (Figures 3-6); wherein the hub has a hub interface comprising a female tapered surface (best shown in Figures 4 and 6) and an injector fitting interface that comprises a male tapered surface (best shown in Figures 4 and 6).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the hub interface and the fitting interface of Singh to include that the hub interface comprises a female tapered surface and the injector fitting interface comprises a male tapered surface based on the teachings of Kreamer to allow the hub to be slidably secured to the injector fitting in a manner that allow for controlled movement between the extended and retracted positions (Kreamer [Col 3, line 60 – Col 4, line 35]; Figures 3-6).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 20170216092) in view of Scheller et al. (US 20130197488) in view of Bley et al. (US 20200330269) as applied to claim 13 above, and further in view of Sinko et al. (USPN 5279590).
Regarding claim 18, modified Singh teaches the injector cannula of claim 13.
Modified Singh fails to explicitly teach the hub has one or more snaps on the hub, and the injector fitting has a plurality of notches spaced apart longitudinally on the injector fitting, the snaps configured to interface with respective notches of the plurality of notches on the injector fitting to retain the hub and tip protector tube separately in the extended position and the retracted position.
Sinko teaches an injector device (Figure 1) comprising an injector fitting (hollow tubular housing 1) and a hub (tubular needle mount 10 having locking tab 20), wherein the hub comprise one or more snaps (locking tab 20), and the injector fitting has a plurality of notches spaced apart longitudinally on the injector fitting (recesses 1b and 1c), the snaps configured to interface with respective notches of the plurality of notches on the injector fitting to retain the hub in the extended position (“The spring 50 will obviously be compressed by the forward movement of the needle mount 10 in housing 1 to the operative position of the needle 15, and will be locked against such spring bias by engagement of the locking tab 20 with the forward recess 1b provided in the housing 1” [Col 7, lines 51-56]) and the retracted position (“the needle can be locked in this inoperative sealed position by rotation of the locking tab 20 into the rearward recess 1c of the housing 1.” [Col 7, lines 63-66]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the hub and injector fitting of Singh such that hte hub comprises snaps and the injector fitting comprises a plurality of notches based on the teachings of Sinko to enable the injector device to be utilized in either operative position without requiring the user to manual retain the hub in the desired position (Sinko [Col 7, lines 44-66]).
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783
/LOAN B JIMENEZ/Supervisory Patent Examiner, Art Unit 3784