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 Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1, line 7: “a distal end of the hub” should read --the distal end of the hub--
Claim 1, lines 8-9: “a proximal end of the hub” should read --the proximal end of the hub--
Claim 4, line 1: “in first direction” should read --in a first direction--
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 9-10 and 17-19 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.
Claim 9 recites “wherein the detent includes protrusions positioned on either side of the detent”, however it is not clear what exactly is meant by “protrusions positioned on either side of the detent”. The Specification, Paragraph [0059] explicitly teaches a detent 522 formed of “opposed projections on either side of the channel 507” (See also Fig. 10), which is categorically different that “a detent including protrusions positioned on either side of the detent”. Clarification requested.
Claim 10 is rejected by virtue of its dependence from claim 9.
Claim 17 recites “positioning the central enclosure over the proximal end of the hub”, however, this claimed feature does not coincide with the Drawings, Figs. 9-10 and 13, which depict the central enclosure surrounding the distal end. Clarification requested. For examination purposes, this feature has been interpreted to recite: “positioning the central enclosure over the distal end of the hub”.
Claims 18-19 are rejected by virtue of their dependence from claim 17.
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, 3-4, 8-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 6835190) (cited by Applicant) in view of Chin (WO 2007133951) (cited by Applicant) and Kuracina (WO 9731666).
Regarding claim 1, Nguyen teaches (Fig. 1) a blood collection assembly, comprising: a needle assembly (4) fixedly coupled to a finger-activated actuator (push element 8) and tubing (18), the needle assembly comprising a needle (16);
However, Nguyen does not teach “a hub including a channel in a top surface of the hub, a proximal end and a distal end, the distal end defining a cavity and a distal passageway, the channel slidably engaging the finger-activated actuator such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position at a proximal end of the hub the needle retracts within the hub; and an active closure assembly including a door and biasing mechanism positioned within the cavity such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door into the distal passageway.
Chin, in a related field of endeavor, teaches (Fig. 2) a hub (20) including a channel (slot 100) in a top surface of the hub (see Fig. 2), a proximal end and a distal end (see Fig. 2), the distal end defining a distal passageway (forward opening 30), the channel slidably engaging the finger-activated actuator (96) such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position at a proximal end of the hub the needle retracts within the hub. (see Figs. 8A, 9A; Paragraph [0065]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “a hub including a channel in a top surface of the hub, a proximal end and a distal end, the distal end defining a cavity and a distal passageway, the channel slidably engaging the finger-activated actuator such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position at a proximal end of the hub the needle retracts within the hub” as taught by Chin. Doing so enables a user to translate the tab member forward and rearward, as needed, during a blood sampling procedure. (Paragraph [0065]).
Kuracina, in a related field of endeavor, teaches a distal end defining a cavity (Figs. 26-27, 31, space containing needle tip guard 41 and elastic member 19); and an active closure assembly (Figs. 30-31, 33) including a door (needle tip guard 41) and biasing mechanism (elastic member 19) positioned within the cavity (Figs. 26-27, 31) such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door into the distal passageway. (See Figs. 30-31).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “an active closure assembly including a door and biasing mechanism positioned within the cavity such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door into the distal passageway”, as taught by Kuracina. Doing so provides a mechanism to contain the sharpened needle tip within the needle guard assembly. (Page 25, lines 25-27).
Regarding claim 3, Nguyen does not teach “wherein the biasing mechanism is a spring”.
Kuracina teaches wherein the biasing mechanism (19) is a spring. (Abstract).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “wherein the biasing mechanism is a spring” as taught by Kuracina. Doing so provides a biasing force for entrapping the needle. (Figs. 30-31).
Regarding claim 4, Nguyen as modified does not teach “wherein the cavity extends in first direction and the distal passageway extends in a second direction, orthogonal to the first direction”.
Kuracina illustrates wherein the cavity extends in first direction (i.e., vertical direction) and the distal passageway (opening 47) extends in a second direction (i.e., horizontal direction), orthogonal to the first direction. (See Figs. 30-31, 33)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “wherein the cavity extends in first direction and the distal passageway extends in a second direction, orthogonal to the first direction” as taught by Kuracina. Doing so provides an internal configuration that enables containment of the needle.
Regarding claim 8, Nguyen as modified does not teach “wherein the channel includes a detent”.
Chin teaches a needle safety device (Fig. 4) comprising a wherein the channel (slot 100) includes a detent (106). (Paragraph [0067]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “wherein the channel includes a detent” as taught by Chin. Doing so provides a structural element for an interference engagement with the finger-activated actuator. (Paragraph [0067]).
Regarding claim 9, Nguyen as modified does not teach “wherein the detent includes protrusions positioned on either side of the detent”.
Chin illustrates (Fig. 4) wherein the detent (106) includes protrusions positioned on either side of the detent. (See Fig. 4, detents 106 comprise protrusions into the channel).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “wherein the detent includes protrusions positioned on either side of the detent” as taught by Chin. Doing so provides additional structural elements for an interference engagement with the finger-activated actuator. (Paragraph [0067]).
Regarding claim 10, Nguyen as modified does not teach “wherein the finger-activated actuator includes recesses positioned within the protrusions when in the first position”.
Chin illustrates (Fig. 1) wherein the finger-activated actuator (96) includes recesses (space under the gripping portion of tab 96) positioned within the protrusions when in the first position (Paragraph [0067] tab 96 may be locked into detents 106 extending into slot 100, providing for an interference engagement therewith.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “wherein the finger-activated actuator includes recesses positioned within the protrusions when in the first position” as taught by Chin. Doing so provides additional structural elements for an interference engagement with the finger-activated actuator. (Paragraph [0067]).
Regarding claim 12, Nguyen as modified does not teach “wherein the channel includes an open end at the proximal end of the hub”.
Chin teaches (Fig. 2) wherein the channel (slot 100) includes an open end at the proximal end of the hub (rearward opening 32).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen to teach “wherein the channel includes an open end at the proximal end of the hub”, as taught by Chin. Doing so may provide an opening to an evacuated tube during blood collection. (Paragraph [0063]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Chin and Kuracina, further in view of Steube (US 5322514).
Regarding claim 5, Nguyen as modified does not teach “a wing assembly including first and second wings connected with a central enclosure”.
Steube, in a related field of endeavor, teaches (Figs. 1-2, 5) a wing assembly (38) including first and second wings (48) connected with a central enclosure (Figs. 5, body 50).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen as modified to teach “a wing assembly including first and second wings connected with a central enclosure”, as taught by Steube. Doing so improves controllability and safety during operation. (Col. 3, lines 3-10).
Regarding claim 6, Nguyen as modified does not teach “wherein the distal end includes a recess configured to receive a corresponding protrusion on the central enclosure”.
Steube teaches (Fig. 7) wherein the distal end includes a recess (side tab slots 60) configured to receive a corresponding protrusion (tabs 44) on the central enclosure (50).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen as modified to teach “wherein the distal end includes a recess configured to receive a corresponding protrusion on the central enclosure”, as taught by Steube. Doing so helps securely position the wing when attached to the needle hub. (Col. 6, lines 30-38).
Regarding claim 7, Nguyen as modified does not teach “wherein the central enclosure surrounds the distal end.”
Steube teaches wherein the central enclosure (50) surrounds the distal end (Col. 4, lines 68-69, protective sheath mount 36 at the distal end of needle hub 8). (See Figs. 7, 10).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen as modified to teach “wherein the central enclosure surrounds the distal end”, as taught by Steube. Doing so provides a region comprising wing mounts where a wing assembly may be securely positioned. (Col. 4, lines 45-57).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Chin and Kuracina, further in view of Wanderer (CA 1304268).
Regarding claim 11, Nguyen as modified does not teach “wherein the channel includes a catch positioned at the proximal end”.
Wanderer, in a related field of endeavor, teaches hypodermic syringe device (Figs. 1, 4) wherein the channel (42) includes a catch (recess 44) positioned at the proximal end. (Page 15, lines 15-22).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen as modified to teach “wherein the channel includes a catch positioned at the proximal end” as taught by Wanderer. Doing so restrains the translation key from unintended movement. (Page 16, lines 11-15).
Claims 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable Chin in view of Kuracina.
Regarding claim 13, Chin teaches a method of forming a blood collection assembly comprising: providing a hub (20) having a channel (100), a proximal end and a distal end (See Fig. 2), the distal end including a distal passageway (forward opening 30), positioning a finger-activated actuator (96) within the channel (100) such that a needle holder (Fig. 2, needle hub 54) of the finger-activated actuator (96) is positioned in the distal passageway (30).
However, Chin does not teach “the distal end including a cavity” and “positioning an active closure assembly in the cavity, the active closure assembly including a door and a biasing mechanism, wherein the biasing mechanism presses the door against the needle holder.”
Kuracina teaches the distal end including a cavity (Figs. 26-27, 31, space containing needle tip guard 41 and elastic member 19); and positioning an active closure assembly in the cavity (Figs. 30-31, 33), the active closure assembly including a door (needle tip guard 41) and a biasing mechanism (elastic member 19), wherein the biasing mechanism presses the door against the needle holder (Fig. 35, needle hub 112). (See Figs. 30-31).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chin to teach “the distal end including a cavity” and “positioning an active closure assembly in the cavity, the active closure assembly including a door and a biasing mechanism, wherein the biasing mechanism presses the door against the needle holder” as taught by Kuracina. Doing so provides a mechanism to contain the sharpened needle tip within the needle guard assembly. (Page 25, lines 25-27).
Regarding claim 14, Chin teaches wherein the channel (100) includes a detent (106) and the finger-activated actuator (96) is positioned within the detent. (Paragraph [0067] detent provides an interference engagement with the finger-activated actuator).
Regarding claim 16, Chin teaches (Fig. 2) wherein the channel (slot 100) includes an open end at the proximal end of the hub (rearward opening 32).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable Chin in view of Kuracina, further in view of Steube.
Regarding claim 17, Chin as modified does not teach “providing a wing assembly having first and second wings connected with a central enclosure; and positioning the central enclosure over the distal end of the hub.”
Steube, as previously discussed, teaches (Figs. 1-2, 5) providing a wing assembly (38) having first and second wings (48) connected with a central enclosure (Fig. 5, body 50); and positioning the central enclosure (50) over the distal end of the hub (See Figs. 7, 10; Col. 4, lines 68-69, body 50 surrounds protective sheath mount 36 at the distal end of needle hub 8).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chin to teach “providing a wing assembly having first and second wings connected with a central enclosure; and positioning the central enclosure over the distal end of the hub”, as taught by Steube. Doing so provides a region comprising wing mounts where a wing assembly may be securely positioned. (Col. 4, lines 45-57).
Regarding claim 18, Chin as modified does not teach “wherein the central enclosure includes a protrusion and the hub includes a recess, wherein the protrusion is positioned within the recess”.
Steube teaches (Fig. 7) wherein the central enclosure (50) includes a protrusion (tabs 44) and the hub includes a recess (60), wherein the protrusion is positioned within the recess.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chin to teach “wherein the central enclosure includes a protrusion and the hub includes a recess, wherein the protrusion is positioned within the recess”, as taught by Steube. Doing so helps securely position the wing when attached to the needle hub. (Col. 6, lines 30-38).
Regarding claim 19, Chin as modified does not teach “wherein the central enclosure includes a front wall and wherein the hub contacts the front wall”.
Steube teaches wherein the central enclosure (50) includes a front wall (edge 70) and wherein the hub (8) contacts the front wall. (Figs. 7, 10, 12).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chin to teach “wherein the central enclosure includes a front wall and wherein the hub contacts the front wall”, as taught by Steube. Doing so helps support positioning of the wing when attached to the needle hub.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of Kuracina, further in view of Wanderer.
Regarding claim 20, Chin as modified does not teach “positioning a catch in the channel”.
Wanderer, as previously discussed, teaches positioning a catch (44) in the channel (42). (Figs. 1, 4; Page 15, lines 15-22).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chin as modified to teach “positioning a catch in the channel” as taught by Wanderer. Doing so restrains the translation key from unintended movement. (Page 16, lines 11-15).
Allowable Subject Matter
Claims 2 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the prior art does not teach “a cap positioned within the hub, wherein the biasing mechanism is positioned between the cap and the door.”
Regarding claim 15, the prior art does not teach “assembling a cap to the hub, wherein the biasing mechanism is positioned between the cap and the door.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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