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
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.
Claims 21, 22, 31 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first embodiment of Shue et al. (PG PUB 2007/0088279).
Re claim 21, Shue (in a first embodiment) discloses a low-profile universal passive protector (all components seen in Fig 9 except for catheter 23 and its hub 22; it is noted that all reference characters cited below refer to Fig 9 unless otherwise noted) for a catheter (it is noted that the phrase “for a catheter” is functional language and, therefore, “a catheter” is not a part of the claimed invention; this limitation is met in view of Fig 9 that shows the protector attached to a catheter 23) comprising: a hypodermic needle 21; an elongate sheath 7 detachably engageable with the catheter (as seen in Fig 12) and defining a longitudinal axis (extending horizontally in Fig 9) and a sheath cavity (within which member 8 resides in Fig 9) extending along the longitudinal axis (as seen in Fig 9); a finger-press plate (the flange located at the proximal end of protector 24, seen but not labeled in Fig 9; labeled in Fig 3) coupled to and extending from the sheath (as seen in Fig 9) and configured to be separate from the catheter (as seen in Fig 3); a slider (the portion of member 8 located outside the box labeled “flashback body” in Fig C below) connected to the hypodermic needle (as seen in Fig 9), irremovably coupled to the elongate sheath (as seen in Fig 12), and movable over and along the sheath between a first position (seen in Fig 9) and a second position (seen in Fig 12), the hypodermic needle being retracted into the sheath cavity as the slider moves from the first position to the second position (as seen in Fig 12; Para 83), the slider including a first end (labeled in Fig C below) facing the finger-press plate and a second end (labeled in Fig C below) opposite the first end (as seen in Fig 9 and Fig C below), the first end defining a first plane (extending vertically in Fig 9) and the second end defining a second plane (extending vertically in Fig 9), both of the first and second planes intersect the longitudinal axis (as seen in Fig 9); and a flashback body (the portion of member 8 located inside the box labeled “flashback body” in Fig C below) coupled to the slider and in fluid communication with the hypodermic needle (Para 86), the flashback body being positioned relative to the slider such that no portion of the flashback body traverses the second plane (as seen in Fig C, the entirety of the flashback body resides distal to the second plane); the finger-press plate being configured to protrude above the slider and flashback body along an axis perpendicular to the longitudinal axis (when the protector is used in orientation that is inverted to the orientation shown in Fig 9; since the finger-press plate is annular, use in this orientation would result in a portion of the finger-press plate residing above the flashback body and the slider) to enable a user's finger to extend over the flashback body and engage with the finger-press plate for imparting a force on the finger-press plate (as seen in Fig 9).
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Re claim 22, Shue (in the first embodiment) discloses that the flashback body is configured to reside entirely between the first plane and the second plane (as seen in Fig 3 and Fig C above).
Re claim 31, Shue (in the first embodiment) discloses that the flashback body is integrally coupled to the slider (as seen in Fig 15).
Re claim 32, Shue (in a first embodiment) discloses a universal passive protector (all components seen in Fig 9 except for catheter 23 and its hub 22; it is noted that all reference characters cited below refer to Fig 9 unless otherwise noted) for a catheter (it is noted that the phrase “for a catheter” is functional language and, therefore, “a catheter” is not a part of the claimed invention; this limitation is met in view of Fig 9 that shows the protector attached to a catheter 23) comprising: a hypodermic needle 21; an elongate sheath 7 detachably engageable with the catheter (as seen in Fig 12) and defining a longitudinal axis (extending horizontally in Fig 9) and a sheath cavity (within which member 8 resides in Fig 9) extending along the longitudinal axis (as seen in Fig 9); a finger-press plate (the flange located at the proximal end of protector 24, seen but not labeled in Fig 9; labeled in Fig 3) coupled to and extending from the sheath (as seen in Fig 9); a slider (the portion of member 8 located outside the box labeled “flashback body” in Fig C above) connected to the hypodermic needle (as seen in Fig 9), irremovably coupled to the elongate sheath (as seen in Fig 12), and movable over and along the sheath between a first position (seen in Fig 9) and a second position (seen in Fig 12), the hypodermic needle being retracted into the sheath cavity as the slider moves from the first position to the second position (as seen in Fig 12; Para 83), the slider including a first end (labeled in Fig C above) facing the finger-press plate and a second end (labeled in Fig C above) opposite the first end (as seen in Fig 9 and Fig C above), the second end defining a plane (extending vertically in Fig 9) that intersects the longitudinal axis (as seen in Fig 9); and a flashback body (the portion of member 8 located inside the box labeled “flashback body” in Fig C above) coupled to the slider and in fluid communication with the hypodermic needle (Para 86), the flashback body being positioned relative to the slider such that no portion of the flashback body traverses the second plane (as seen in Fig C, the entirety of the flashback body resides distal to the second plane); the finger-press plate being configured to protrude above the flashback body along an axis perpendicular to the longitudinal axis (when the protector is used in orientation that is inverted to the orientation shown in Fig 9; since the finger-press plate is annular, use in this orientation would result in a portion of the finger-press plate residing above the flashback body and the slider).
Claims 21, 23, 31, 32 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second embodiment of Shue et al. (PG PUB 2007/0088279).
Re claim 21, Shue (in a second embodiment) discloses a low-profile universal passive protector (all components seen in Fig 18 except for catheter 23 and its hub 22; it is noted that all reference characters cited below refer to Fig 18 unless otherwise noted) for a catheter (it is noted that the phrase “for a catheter” is functional language and, therefore, “a catheter” is not a part of the claimed invention; this limitation is met in view of Fig 18 that shows the protector attached to a catheter 23) comprising: a hypodermic needle 21; an elongate sheath 7 detachably engageable with the catheter (as seen in Fig 19) and defining a longitudinal axis (extending horizontally in Fig 18) and a sheath cavity (within which slider 8 resides in Fig 18) extending along the longitudinal axis (as seen in Fig 18); a finger-press plate (the flange located at the proximal end of protector 24) coupled to and extending from the sheath (as seen in Fig 18) and configured to be separate from the catheter (as seen in Fig 19); a slider 8 connected to the hypodermic needle (as seen in Fig 18), irremovably coupled to the elongate sheath (as seen in Fig 19), and movable over and along the sheath between a first position (seen in Fig 18) and a second position (seen in Fig 19), the hypodermic needle being retracted into the sheath cavity as the slider moves from the first position to the second position (as seen in Fig 19; Para 30), the slider including a first end (labeled in Fig B below) facing the finger-press plate and a second end (labeled in Fig B below) opposite the first end (as seen in Fig 18, the second end is distal the first end) (it is noted that the claim does not require the “first end” or the “second end” to be at the terminal ends of the slider; rather, any element of the slider can have a “first end” and/or a “second end”), the first end defining a first plane (inclined relative to the longitudinal axis, as seen in Fig B below) and the second end defining a second plane (extending vertically in Fig 18), both of the first and second planes intersect the longitudinal axis (as seen in Fig 18 and Fig B below); and a flashback body 3+4 coupled to the slider and in fluid communication with the hypodermic needle (Para 89), the flashback body being positioned relative to the slider such that no portion of the flashback body traverses the second plane (as seen in Fig B, the entirety of the flashback body resides proximal to the second plane); the finger-press plate being configured to protrude above the slider and flashback body along an axis perpendicular to the longitudinal axis (when the protector is used in orientation that is inverted to the orientation shown in Fig 18; since the finger-press plate is annular, use in this orientation would result in a portion of the finger-press plate residing above the flashback body and the slider) to enable a user's finger to extend over the flashback body and engage with the finger-press plate for imparting a force on the finger-press plate (as seen in Fig 18).
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Re claim 23, Shue (in the second embodiment) discloses that the flashback body includes a flashback plate 42 and a flashback cylinder 32 coupled to the flashback plate, the flashback plate defining a plane (labeled as “plane FP” in Fig B above) that is substantially parallel to the longitudinal axis (as seen in Fig B above, the plane of the flashback plate is substantially parallel to the horizontal axis (which correlates to the longitudinal axis)), and the flashback cylinder defining a cylinder axis (labeled “plane FC” in Fig B above) substantially parallel to the longitudinal axis (as seen in Fig B above, the plane of the flashback cylinder is substantially parallel to the horizontal axis (which correlates to the longitudinal axis)).
Re claim 31, Shue (in the second embodiment) discloses that the flashback body is integrally coupled to the slider (Para 89).
Re claim 32, Shue (in a second embodiment) discloses a universal passive protector (all components seen in Fig 18 except for catheter 23 and its hub 22; it is noted that all reference characters cited below refer to Fig 18 unless otherwise noted) for a catheter (it is noted that the phrase “for a catheter” is functional language and, therefore, “a catheter” is not a part of the claimed invention; this limitation is met in view of Fig 18 that shows the protector attached to a catheter 23) comprising: a hypodermic needle 21; an elongate sheath 7 detachably engageable with the catheter (as seen in Fig 19) and defining a longitudinal axis (extending horizontally in Fig 18) and a sheath cavity (within which slider 8 resides in Fig 18) extending along the longitudinal axis (as seen in Fig 18); a finger-press plate (the flange located at the proximal end of protector 24) coupled to and extending from the sheath (as seen in Fig 18); a slider 8 connected to the hypodermic needle (as seen in Fig 18), irremovably coupled to the elongate sheath (as seen in Fig 19), and movable over and along the sheath between a first position (seen in Fig 18) and a second position (seen in Fig 19), the hypodermic needle being retracted into the sheath cavity as the slider moves from the first position to the second position (as seen in Fig 19; Para 30), the slider including a first end (labeled in Fig B below) facing the finger-press plate and a second end (labeled in Fig B below) opposite the first end (as seen in Fig 18, the second end is distal the first end) (it is noted that the claim does not require the “first end” or the “second end” to be at the terminal ends of the slider; rather, any element of the slider can have a “first end” and/or a “second end”), the second end defining a plane (extending vertically in Fig 18) that intersects the longitudinal axis (as seen in Fig 18 and Fig B above); and a flashback body 3+4 coupled to the slider and in fluid communication with the hypodermic needle (Para 89), the flashback body being positioned relative to the slider such that no portion of the flashback body traverses the plane defined by the second end (as seen in Fig B, the entirety of the flashback body resides proximal to the second plane); the finger-press plate being configured to protrude above the flashback body along an axis perpendicular to the longitudinal axis (when the protector is used in orientation that is inverted to the orientation shown in Fig 18; since the finger-press plate is annular, use in this orientation would result in a portion of the finger-press plate residing above the flashback body).
Re claim 33, Shue (in the second embodiment) discloses that the flashback body includes a flashback plate 42 and a flashback cylinder 32 coupled to the flashback plate, the flashback plate defining a plane (labeled as “plane FP” in Fig B above) that is substantially parallel to the longitudinal axis (as seen in Fig B above, the plane of the flashback plate is substantially parallel to the horizontal axis (which correlates to the longitudinal axis)), and the flashback cylinder defining a cylinder axis (labeled “plane FC” in Fig B above) substantially parallel to the longitudinal axis (as seen in Fig B above, the plane of the flashback cylinder is substantially parallel to the horizontal axis (which correlates to the longitudinal axis)).
Claims 21, 28, 29, 31, 32, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maan et al. (PG PUB 2011/0015573).
Re claim 21, Maan discloses a low-profile universal passive protector 18 (Fig 3,6; all reference characters cited below refer to Fig 3 unless otherwise noted) for a catheter (it is noted that the phrase “for a catheter” is functional language and, therefore, “a catheter” is not a part of the claimed invention; this limitation is met in view of Fig 3 that shows the protector 18 attached to a catheter 3) comprising: a hypodermic needle 2; an elongate sheath 14 detachably engageable with the catheter (as seen in Fig 6) and defining a longitudinal axis (extending horizontally in Fig 3) and a sheath cavity (within which slider 15 resides in Fig 3) extending along the longitudinal axis (as seen in Fig 3); a finger-press plate 5 coupled to and extending from the sheath and configured to be separate from the catheter (as seen in Fig 6); a slider 13 connected to the hypodermic needle (as seen in Fig 3), irremovably coupled to the elongate sheath (as seen in Fig 5, due to locking mechanism 19, Para 83), and movable over and along the sheath between a first position (seen in Fig 3) and a second position (seen in Fig 5), the hypodermic needle being retracted into the sheath cavity as the slider moves from the first position to the second position (Para 83), the slider including a first end (labeled in Fig A below) facing the finger-press plate and a second end (labeled in Fig A below) opposite the first end (it is noted that the claim does not require the “first end” or the “second end” to be at the terminal ends of the slider; rather, any element of the slider can have a “first end” and/or a “second end”), the first end defining a first plane (extending vertically in Fig 3) and the second end defining a second plane (extending vertically in Fig 3), both of the first and second planes intersect the longitudinal axis (as seen in Fig 3); and a flashback body 16 coupled to the slider and in fluid communication with the hypodermic needle (Para 74), the flashback body being positioned relative to the slider such that no portion of the flashback body traverses the second plane (as seen in Fig 3, the entirety of the flashback body 16 resides proximal to the second plane); the finger-press plate being configured to protrude above the slider and the flashback body along an axis perpendicular to the longitudinal axis (when the protector is used in orientation that is inverted to the orientation shown in Fig 3; since the finger-press plate is annular, use in this orientation would result in a portion of the finger-press plate residing above the flashback body and the slider) to enable a user's finger to extend over the flashback body and engage with the finger-press plate for imparting a force on the finger-press plate (as seen in Fig 6).
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Re claim 28, Maan discloses a locking element 15 coupled to the sheath, the slider engaging with the locking element when the slider is in a prescribed position to lock the slider relative to the sheath (as seen in Fig 4(a),4(b), Para 83).
Re claim 29, Maan discloses that the locking element includes a locking element locking tab (labeled in Fig A above); and the slider includes a slider locking tab (labeled in Fig A above) configured to engage with the locking element locking tab when the slider is in the prescribed position, the engagement between the locking element locking tab and the slider locking tab restricting movement of the slider from the prescribed position (Para 83).
Re claim 31, Maan discloses that the flashback body is integrally coupled to the slider (Para 82, the two are considered “integrally coupled” as they require coupling in order for the flashback body to serve its purpose; it is noted that the phrase “integrally coupled” does not require the elements to be integrally formed with each other).
Re claim 32, Maan discloses a universal passive protector 18 (Fig 3,6; all reference characters cited below refer to Fig 3 unless otherwise noted) for a catheter (it is noted that the phrase “for a catheter” is functional language and, therefore, “a catheter” is not a part of the claimed invention; this limitation is met in view of Fig 3 that shows the protector 18 attached to a catheter 3) comprising: a hypodermic needle 2; an elongate sheath 14 detachably engageable with the catheter (as seen in Fig 6) and defining a longitudinal axis (extending horizontally in Fig 3) and a sheath cavity (within which slider 15 resides in Fig 3) extending along the longitudinal axis (as seen in Fig 3); a finger-press plate 5 coupled to and extending from the sheath (as seen in Fig 6); a slider 13 connected to the hypodermic needle (as seen in Fig 3), irremovably coupled to the elongate sheath (as seen in Fig 5, due to locking mechanism 19, Para 83), and movable over and along the sheath between a first position (seen in Fig 3) and a second position (seen in Fig 5), the hypodermic needle being retracted into the sheath cavity as the slider moves from the first position to the second position (Para 83), the slider including a first end (labeled in Fig A below) facing the finger-press plate and a second end (labeled in Fig A below) opposite the first end (it is noted that the claim does not require the “first end” or the “second end” to be at the terminal ends of the slider; rather, any element of the slider can have a “first end” and/or a “second end”), the second end defining a plane (extending vertically in Fig 3) that intersects the longitudinal axis (as seen in Fig 3); and a flashback body 16 coupled to the slider and in fluid communication with the hypodermic needle (Para 74), the flashback body being positioned relative to the slider such that no portion of the flashback body traverses the plane defined by the second end (as seen in Fig 3, the entirety of the flashback body 16 resides proximal to the plane); the finger-press plate being configured to protrude above the flashback body along an axis perpendicular to the longitudinal axis (when the protector is used in orientation that is inverted to the orientation shown in Fig 3; since the finger-press plate is annular, use in this orientation would result in a portion of the finger-press plate residing above the flashback body).
Re claim 38, Maan discloses a locking element 15 coupled to the sheath, the slider engaging with the locking element when the slider is in a prescribed position to lock the slider relative to the sheath (as seen in Fig 4(a),4(b), Para 83).
Re claim 39, Maan discloses that the locking element includes a locking element locking tab (labeled in Fig A above); and the slider includes a slider locking tab (labeled in Fig A above) configured to engage with the locking element locking tab when the slider is in the prescribed position, the engagement between the locking element locking tab and the slider locking tab restricting movement of the slider from the prescribed position (Para 83).
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 23-27 and 33-37 are rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Shue et al. (PG PUB 2007/0088279) in view of Luther et al. (US Pat 6,981,965).
Re claim 23, Shue (in the first embodiment) discloses that the flashback body includes a distal portion (the portion of member 8 proximal to the portion in which portion 122 of member 1 resides in Fig 15) and a flashback cylinder (the portion of 8 in which portion 122 of member 1 resides in Fig 15) coupled to the flashback plate, the flashback cylinder defining a cylinder axis substantially parallel to the longitudinal axis (as seen in Fig 3). Shue does not disclose that the flashback plate defines a plane that is substantially parallel to the longitudinal axis. Luther, however, teaches a substantially similar protector 20 (Fig 1A) comprising a slider 92 (Fig 1A,3; which like Shue’s slider is directly below the flashback body) and a flashback body 94 (Fig 1A,3; which like Shue’s flashback body is directly attached to the top of the slider), wherein the flashback body includes a flashback plate (labeled in annotated Fig D below and similar in profile to the distal portion of Shue’s flashback body) and a flashback cylinder (labeled in annotated Fig D below and similar in profile to the proximal portion of Slue’s flashback body) coupled to the flashback plate (as seen in Fig 3 and Fig D below), the flashback plate defining a plane (as seen in Fig 1A) and the flashback cylinder defining a cylinder axis (extending horizontally in Fig 3) substantially parallel to a longitudinal axis of the sheath (as seen in Fig 1A,3); Luther teaches that providing the flashback body with such a configuration results in the flashback chamber filling with blood so that, once a vein has been pierced, a medical technician is provided with an indication of whether the needle has been properly inserted into the vein (Col 9, Line 61 — Col 10, Line 5 and Col 10, Lines 25-26). Although Shue discloses that blood can be seen within tubular bent member 27 inside the flashback body (Para 86), one of ordinary skill in the art would recognize that a larger cavity within the flashback body – like that of Luther – would provide a more easily seen indication. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first embodiment of Shue to include the flashback body such that it is shaped like that of Luther (which includes a plate that defines a plane) for the purpose of providing a flashback body that will fill with blood once a vein has been pierced to provide a medical technician with a more easily seen indication that the needle has been properly inserted into the vein (Col 9, Line 61 — Col 10, Line 5 and Col 10, Lines 25-26). Luther does not disclose that the plane defined by the flashback plate is substantially parallel to the longitudinal axis. However, it would have been an obvious matter of design choice to modify the flashback plate to define a plane that is substantially parallel to the longitudinal axis since applicant has not disclosed that having such a configuration solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this configuration, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Further, it would have been an obvious matter of design choice to make the flashback plate define a plane that is substantially parallel to the longitudinal axis since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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Reclaim 24, Shue (in the first embodiment) as modified by Luther in the rejection of claim 23 above disclose all the claimed features with Luther teaching that the flashback cylinder defines an opening (labeled in annotated Fig D above) associated with a radius that extends into the flashback plate (as seen in Fig 3 and annotated Fig D above). Since the rejection of claim 23 above sets forth that Shue’s flashback body would be modified to comprise the shape of Luther’s flashback body, the motivation applied in the rejection of claim 23 also pertains to claim 24. Luther does not explicitly disclose that this opening is cylindrical. However, it would have been an obvious matter of design choice to modify the opening to be cylindrical since applicant has not disclosed that having such a configuration solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this shape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Further, it would have been an obvious matter of design choice to make the opening cylindrical since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Re claim 25, both Shue (in the first embodiment) and Luther disclose that the flashback cylinder is integrally formed with the flashback plate (as seen in Fig 15 of Shue and Fig 3 of Luther).
Re claim 26, Shue (in the first embodiment) as modified by Luther in the rejection of claim 23 above disclose all the claimed features with Luther teaching that the flashback cylinder includes a curved end portion (labeled in annotated Fig D above; because this portion is cylindrical in shape, it is “curved”) and an opposing open end portion (labeled in annotated Fig D above) opposite the curved end portion, the flashback cylinder being arranged such that the curved end portion extends toward the flashback plate and faces the finger-press plate and the open end portion traverses a plane defined by an exposed outer surface parallel to the longitudinal axis (as seen in Fig 3 and annotated Fig D above). Since the rejection of claim 23 above sets forth that Shue’s flashback body would be modified to comprise the shape of Luther's flashback body, the motivation applied in the rejection of claim 23 also pertains to claim 26.
Re claim 27, Shue as modified by Luther in the rejections of claim 23 and 26 above disclose all the claimed features with Shue disclosing that the curved end portion intersects with the flashback plate at an approximate midpoint of the slider in a longitudinal cross section generally perpendicular to the flashback plate (as seen in Fig 15 of Shue).
Re claim 33, Shue (in the first embodiment) discloses that the flashback body includes a distal portion (the portion of member 8 proximal to the portion in which portion 122 of member 1 resides in Fig 15) and a flashback cylinder (the portion of 8 in which portion 122 of member 1 resides in Fig 15) coupled to the flashback plate, the flashback cylinder defining a cylinder axis substantially parallel to the longitudinal axis (as seen in Fig 3). Shue does not disclose that the flashback plate defines a plane that is substantially parallel to the longitudinal axis. Luther, however, teaches a substantially similar protector 20 (Fig 1A) comprising a slider 92 (Fig 1A,3; which like Shue’s slider is directly below the flashback body) and a flashback body 94 (Fig 1A,3; which like Shue’s flashback body is directly attached to the top of the slider), wherein the flashback body includes a flashback plate (labeled in annotated Fig D above and similar in profile to the distal portion of Shue’s flashback body) and a flashback cylinder (labeled in annotated Fig D above and similar in profile to the proximal portion of Shue’s flashback body) coupled to the flashback plate (as seen in Fig 3 and Fig D above), the flashback plate defining a plane (as seen in Fig 1A) and the flashback cylinder defining a cylinder axis (extending horizontally in Fig 3) substantially parallel to a longitudinal axis of the sheath (as seen in Fig 1A,3); Luther teaches that providing the flashback body with such a configuration results in the flashback chamber filling with blood so that, once a vein has been pierced, a medical technician is provided with an indication of whether the needle has been properly inserted into the vein (Col 9, Line 61 — Col 10, Line 5 and Col 10, Lines 25-26). Although Shue discloses that blood can be seen within tubular bent member 27 inside the flashback body (Para 86), one of ordinary skill in the art would recognize that a larger cavity within the flashback body – like that of Luther – would provide a more easily seen indication. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first embodiment of Shue to include the flashback body such that it is shaped like that of Luther (which includes a plate that defines a plane) for the purpose of providing a flashback body that will fill with blood once a vein has been pierced to provide a medical technician with a more easily seen indication that the needle has been properly inserted into the vein (Col 9, Line 61 — Col 10, Line 5 and Col 10, Lines 25-26). Luther does not disclose that the plane defined by the flashback plate is substantially parallel to the longitudinal axis. However, it would have been an obvious matter of design choice to modify the flashback plate to define a plane that is substantially parallel to the longitudinal axis since applicant has not disclosed that having such a configuration solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this configuration, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Further, it would have been an obvious matter of design choice to make the flashback plate define a plane that is substantially parallel to the longitudinal axis since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Re claim 34, Shue (in the first embodiment) as modified by Luther in the rejection of claim 33 above disclose all the claimed features with Luther teaching that the flashback cylinder defines an opening (labeled in annotated Fig D above) having a radius relative to the cylinder axis (as seen in Fig D above), which extends into the flashback plate (as seen in Fig 3 and annotated Fig D above). Since the rejection of claim 33 above sets forth that Shue’s flashback body would be modified to comprise the shape of Luther’s flashback body, the motivation applied in the rejection of claim 33 also pertains to claim 34. Luther does not explicitly disclose that this opening is cylindrical or that it traverses the plane defined by the flashback plate. However, it would have been an obvious matter of design choice to modify the opening to be cylindrical and traverse the plane defined by the flashback plate since applicant has not disclosed that having such a configuration solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of this shape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Further, it would have been an obvious matter of design choice to make the opening cylindrical and traverse the plane defined by the flashback plate since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Re claim 35, both Shue (in the first embodiment) and Luther disclose that the flashback cylinder is integrally formed with the flashback plate (as seen in Fig 15 of Shue and Fig 3 of Luther).
Re claim 36, Shue (in the first embodiment) as modified by Luther in the rejection of claim 33 above disclose all the claimed features with Luther teaching that the flashback cylinder includes a curved end portion (labeled in annotated Fig D above; because this portion is cylindrical in shape, it is “curved”) and an opposing open end portion (labeled in annotated Fig D above) opposite the curved end portion, the flashback cylinder being arranged such that the curved end portion extends toward the flashback plate and faces the finger-press plate (as seen in Fig 3 and annotated Fig D above). Since the rejection of claim 33 above sets forth that Shue’s flashback body would be modified to comprise the shape of Luther’s flashback body, the motivation applied in the rejection of claim 33 also pertains to claim 36.
Re claim 37, Shue (in the first embodiment) as modified by Luther in the rejections of claim 33 and 36 above disclose all the claimed features with Shue disclosing that the curved end portion intersects with the flashback plate at an approximate midpoint of the slider in a longitudinal cross section generally perpendicular to the flashback plate (as seen in Fig 15 of Shue).
Claims 28, 29, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Shue et al. (PG PUB 2007/0088279) in view of Maan et al. (PG PUB 2011/0015573).
Re claims 28, 29, 38 and 39, the first embodiment of Shue discloses all the claimed features except a locking element coupled to the sheath, the slider engaging with the locking element when the slider is in a prescribed position to lock the slider relative to the sheath (as required by claims 28 and 38), wherein the locking element includes a locking element locking tab and the slider includes a slider locking tab configured to engage with the locking element locking tab when the slider is in the prescribed position, the engagement between the locking element locking tab and the slider locking tab restricting movement of the slider from the prescribed position (as required by claims 29 and 39). Maan, however, teaches a substantially similar protector 18 (Fig 3,6; all reference characters cited below refer to Fig 3 unless otherwise noted) comprising a hypodermic needle 2, an elongate sheath 14, and a slider 13; Maan further teaches a locking element 15 coupled to the sheath, wherein the slider engages with the locking element when the slider is in a prescribed position to lock the slider relative to the sheath (as seen in Fig 4(a),4(b), Para 83), wherein the locking element includes a locking element locking tab (labeled in Fig A above) and the slider includes a slider locking tab (labeled in Fig A above) configured to engage with the locking element locking tab when the slider is in the prescribed position, the engagement between the locking element locking tab and the slider locking tab restricting movement of the slider from the prescribed position (Para 83) for the purpose of preventing forward motion of the needle after it has been withdrawn (Para 83). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first embodiment of Shue to include a locking element, as taught by Maan, for the purpose of preventing forward motion of the needle after it has been withdrawn (Para 83).
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Shue et al. (PG PUB 2007/0088279) in view of Sheridan (US Pat 3,612,050).
Re claims 30 and 40, the first embodiment of Shue discloses all the claimed features except that the hypodermic needle includes a stepped shoulder adapted to abut against a hardened distal tip of the catheter (again, it is noted that the “catheter” is not a part of the claimed invention since it is only functionally recited). Sheridan, however, teaches a needle 14 (Fig 2) including a stepped shoulder 20 (Fig 2,3) adapted to abut against a hardened distal tip of a catheter (as seen in Fig 2, wherein catheter 6 includes a hardened distal tip 22 (“semirigid”, Col 3, Lines 57-60)) for the purpose of forming a configuration that permits smooth entry of the combined needle and catheter upon piercing, serving to reduce phlebitis, subcutaneous hematomas or similar undesired occurrences which may produce discomfort or other undesired reactions (Col 4, Lines 46-53). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first embodiment of Shue to include the needle with a stepped shoulder, as taught by Sheridan, for the purpose of forming a configuration that permits smooth entry of the combined needle and catheter upon piercing, serving to reduce phlebitis, subcutaneous hematomas or similar undesired occurrences which may produce discomfort or other undesired reactions (Col 4, Lines 46-53).
Claims 28, 29, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over the second embodiment of Shue et al. (PG PUB 2007/0088279) in view of Maan et al. (PG PUB 2011/0015573).
Re claims 28, 29, 38 and 39, the second embodiment of Shue discloses all the claimed features except a locking element coupled to the sheath, the slider engaging with the locking element when the slider is in a prescribed position to lock the slider relative to the sheath (as required by claims 28 and 38), wherein the locking element includes a locking element locking tab and the slider includes a slider locking tab configured to engage with the locking element locking tab when the slider is in the prescribed position, the engagement between the locking element locking tab and the slider locking tab restricting movement of the slider from the prescribed position (as required by claims 29 and 39). Maan, however, teaches a substantially similar protector 18 (Fig 3,6; all reference characters cited below refer to Fig 3 unless otherwise noted) comprising a hypodermic needle 2, an elongate sheath 14, and a slider 13; Maan further teaches a locking element 15 coupled to the sheath, wherein the slider engages with the locking element when the slider is in a prescribed position to lock the slider relative to the sheath (as seen in Fig 4(a),4(b), Para 83), wherein the locking element includes a locking element locking tab (labeled in Fig A above) and the slider includes a slider locking tab (labeled in Fig A above) configured to engage with the locking element locking tab when the slider is in the prescribed position, the engagement between the locking element locking tab and the slider locking tab restricting movement of the slider from the prescribed position (Para 83) for the purpose of preventing forward motion of the needle after it has been withdrawn (Para 83). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the second embodiment of Shue to include a locking element, as taught by Maan, for the purpose of preventing forward motion of the needle after it has been withdrawn (Para 83).
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over the second embodiment of Shue et al. (PG PUB 2007/0088279) in view of Sheridan (US Pat 3,612,050).
Re claims 30 and 40, the second embodiment of Shue discloses all the claimed features except that the hypodermic needle includes a stepped shoulder adapted to abut against a hardened distal tip of the catheter (again, it is noted that the “catheter” is not a part of the claimed invention since it is only functionally recited). Sheridan, however, teaches a needle 14 (Fig 2) including a stepped shoulder 20 (Fig 2,3) adapted to abut against a hardened distal tip of a catheter (as seen in Fig 2, wherein catheter 6 includes a hardened distal tip 22 (“semirigid”, Col 3, Lines 57-60)) for the purpose of forming a configuration that permits smooth entry of the combined needle and catheter upon piercing, serving to reduce phlebitis, subcutaneous hematomas or similar undesired occurrences which may produce discomfort or other undesired reactions (Col 4, Lines 46-53). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the second embodiment of Shue to include the needle with a stepped shoulder, as taught by Sheridan, for the purpose of forming a configuration that permits smooth entry of the combined needle and catheter upon piercing, serving to reduce phlebitis, subcutaneous hematomas or similar undesired occurrences which may produce discomfort or other undesired reactions (Col 4, Lines 46-53).
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Maan et al. (PG PUB 2011/0015573) in view of Sheridan (US Pat 3,612,050).
Re claims 30 and 40, Maan discloses all the claimed features except that the hypodermic needle includes a stepped shoulder adapted to abut against a hardened distal tip of the catheter (again, it is noted that the “catheter” is not a part of the claimed invention since it is only functionally recited). Sheridan, however, teaches a needle 14 (Fig 2) including a stepped shoulder 20 (Fig 2,3) adapted to abut against a hardened distal tip of a catheter (as seen in Fig 2, wherein catheter 6 includes a hardened distal tip 22 (“semirigid”, Col 3, Lines 57-60)) for the purpose of forming a configuration that permits smooth entry of the combined needle and catheter upon piercing, serving to reduce phlebitis, subcutaneous hematomas or similar undesired occurrences which may produce discomfort or other undesired reactions (Col 4, Lines 46-53). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Maan to include the needle with a stepped shoulder, as taught by Sheridan, for the purpose of forming a configuration that permits smooth entry of the combined needle and catheter upon piercing, serving to reduce phlebitis, subcutaneous hematomas or similar undesired occurrences which may produce discomfort or other undesired reactions (Col 4, Lines 46-53).
Response to Arguments
Applicant’s arguments filed 10/21/2025 have been fully considered but are not persuasive. Applicant argues that the amendments to claims 21 and 32 requiring the finger-press plate to be configured to protrude above the flashback body (and, for claim 21, the slider) along an axis perpendicular to the longitudinal axis overcomes the Shue and Mann references utilized in the 102(a)(1) rejections of these claims in the last Office Action. This argument is not persuasive since – as set forth in the rejections above – the protectors of Shue and Mann can be used in an orientation such that the flashback body protrudes downward from the elongate sheath (thus in an inverted orientation to that seen in Fig 9 and 18 of Shue and in Fig 3 of Mann); since the finger-press plates of each of Shue and Mann are annular, use in this orientation would result in the finger-press plates residing above their respective flashback bodies as claimed. To overcome these rejections, the Applicant could amend the claims to also require the flashback chamber to be oriented “above” the slider, thus requiring the flashback chamber and the finger-press plate to project in the same direction from the longitudinal axis.
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 mailing date of this final action.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783