DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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 1-4, 6-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190021640) (cited by Applicant).
Regarding claim 1, Burkholz teaches a blood draw kit (Figs. 2A-2C) comprising: a first delivery device (10), comprising: a first housing (28) with a distal end configured to couple to a catheter assembly (14); and a first tubular instrument (12) with a proximal end secured to the first housing (28), and a distal end configured to advance distally from the first housing (28) and the catheter assembly (14). (Paragraphs [0040]-[0048]).
Burkholz does not specifically teach “a second delivery device, comprising: a second housing with a distal end configured to couple to the catheter assembly; and a second tubular instrument with a proximal end secured to the second housing, and a distal end configured to advance distally from the second housing and the catheter assembly, wherein the second tubular instrument is longer than the first tubular instrument.”
However, the second delivery device merely duplicates a first delivery device and alters the physical length of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Providing a first delivery device of length X and a second delivery device of length Y (where Y > X), both configured to attach to the same standard catheter hub, is a simple combination of known elements. The first device performs its known function (i.e., shorter deployment), and the second performs its known function (i.e., longer deployment) without changing the fundamental principle of operation.
Regarding claim 2, Burkholz does not specifically teach “wherein the second housing is longer than the first housing”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Providing a first delivery device with a first housing of length X and a second delivery device with a second housing of length Y (where Y > X), both configured to attach to the same standard catheter hub, is a simple combination of known elements. The first device performs its known function (i.e., shorter deployment), and the second performs its known function (i.e., longer deployment) without changing the fundamental principle of operation.
Regarding claim 3, Burkholz contemplates (Figs. 2D, 2F) wherein the first delivery device (10) further comprises a first blood collection tube holder (48) attached to the proximal end of the first tubular instrument (12). (Fig. 2D illustrates a blood collection tube 48 disposed within the cavity of the adapter 36; Fig. 2F illustrates adapter at the proximal end of first tubular instrument).
Burkholz does not specifically teach “wherein the second delivery device further comprises a second blood collection tube holder attached to the proximal end of the second tubular instrument”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a first delivery device with a first blood collection tube holder and a second delivery device with a second blood collection tube holder, both configured to attach to a first and second tubular instrument, respectively, is a simple combination of known elements. The first blood collection tube holder performs its known function (i.e., blood collection), and the second blood collection tube holder performs its known function (i.e., blood collection) without changing the fundamental principle of operation.
Regarding claim 4, Burkholz teaches (Figs. 2A, 2D) wherein the first blood collection tube holder (48) and the first tubular instrument (12) are slidable in unison (via advancement tab 46) with respect to the first housing (See Figs. 2A and 2D; Paragraph [0060]).
Burkholz does not specifically teach “wherein the second blood collection tube holder and the second tubular instrument are slidable in unison with respect to the second housing”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a first delivery device with a first blood collection tube holder and a second delivery device with a second blood collection tube holder, both configured to slide in unison with respective to the first and second housing, respectively, is a simple combination of known elements. The first blood collection tube holder and first tubular instrument perform its known function (i.e., advancement and blood collection), and the second blood collection tube holder and second tubular instrument perform its known function (i.e., advancement and blood collection) without changing the fundamental principle of operation.
Regarding claim 6, Burkholz teaches (Fig. 1B) wherein the distal end of the first tubular instrument (12) comprises a plurality of side holes (44). (Paragraph [0055]).
Burkholz does not specifically teach “wherein the distal end of the second tubular instrument comprises a plurality of side holes”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a first tubular instrument with a plurality of side holes and a second tubular instrument with a plurality of side holes, is a simple combination of known elements. The first tubular instrument with a plurality of side holes performs its known function (i.e., facilitate blood flow into the catheter), and the second tubular instrument with a plurality of side holes performs its known function (i.e., facilitate blood flow into the catheter) without changing the fundamental principle of operation.
Regarding claim 7, Burkholz teaches (Fig. 2D) wherein the distal end of the first housing (28) and the comprises an adapter (30) configured to couple to the catheter assembly (14).
Burkholz does not specifically teach “wherein the distal end of the second housing comprises an adapter configured to couple to the catheter assembly”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a first housing comprising an adapter configured to couple to the catheter assembly and a second housing comprising an adapter configured to couple to the catheter assembly, is a simple combination of known elements. The first housing comprising an adapter configured to couple to the catheter assembly performs its known function (i.e., connection with the catheter to facilitate blood flow into the catheter), and the second housing comprising an adapter configured to couple to the catheter assembly performs its known function (i.e., connection with the catheter to facilitate blood flow into the catheter) without changing the fundamental principle of operation.
Regarding claim 8, Burkholz illustrates (Fig. 2G) wherein the first housing (28) comprises a first marking (53) representative of a first time of use for the first delivery device (10).
Burkholz does not specifically teach “the second housing comprises a second marking representative of a second time of use for the second delivery device”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a first housing comprising a first marking representative of a first time of use for the first delivery device and the second housing comprising a second marking representative of a second time of use for the second delivery device, is a simple combination of known elements. The first housing comprising a first marking performs its known function (i.e., representing a first time of use for the first delivery device), and the second housing comprising a second marking performs its known function (i.e., representing a second time of use for the second delivery device) without changing the fundamental principle of operation.
Regarding claim 9, Burkholz teaches (Fig. 2A) wherein the first housing (28) comprises a slot (34), the first delivery device further comprises a slider (46) coupled to the first tubular instrument (12) and slidable along the slot (34). (Paragraph [0060]).
Regarding claim 10, Burkholz teaches wherein the first housing (28) comprises a marking (53), (Fig. 2G), and wherein in response to advancing the slider to the marking, the distal end of the first tubular instrument (12) is flush with a distal tip of the catheter assembly (14). (Figs. 1A-1C depicts advancement of slider such that the distal end of the first tubular instrument is flush with a distal tip of the catheter assembly).
Regarding claim 11, Burkholz does specifically not teach “wherein the second tubular instrument is longer than the first tubular instrument by 0.5 inches or less”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Providing a first delivery device of length X and a second delivery device of length Y (where Y > X), both configured to attach to the same standard catheter hub, is a simple combination of known elements. The first device performs its known function (i.e., shorter deployment), and the second performs its known function (i.e., longer deployment) without changing the fundamental principle of operation.
Regarding claim 12, Burkholz does not specifically teach “a third delivery device, comprising: a third housing with a distal end configured to couple to the catheter assembly; and a third tubular instrument with a proximal end secured to the third housing, and a distal end configured to advance distally from the third housing and the catheter assembly, wherein the third tubular instrument is longer than the second tubular instrument”.
However, the third delivery device merely duplicates a second delivery device and alters the physical length of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Providing a second delivery device of length X and a third delivery device of length Y (where Y > X), both configured to attach to the same standard catheter hub, is a simple combination of known elements. The second device performs its known function (i.e., shorter deployment), and the third performs its known function (i.e., longer deployment) without changing the fundamental principle of operation.
Regarding claim 13, Burkholz does not specifically teach “wherein the third housing is longer than the second housing”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Providing a second delivery device with a second housing of length X and a third delivery device with a third housing of length Y (where Y > X), both configured to attach to the same standard catheter hub, is a simple combination of known elements. The second device performs its known function (i.e., shorter deployment), and the third performs its known function (i.e., longer deployment) without changing the fundamental principle of operation.
Regarding claim 14, Burkholz does not specifically teach “wherein the third delivery device further comprises a third blood collection tube holder attached to the proximal end of the third tubular instrument”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the third housing of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a third delivery device with a third blood collection tube holder configured to attach to a third tubular instrument, is a simple combination of known elements. The third blood collection tube holder performs its known function (blood collection) without changing the fundamental principle of operation.
Regarding claim 15, Burkholz does not specifically teach “wherein the third blood collection tube holder and the third tubular instrument are slidable in unison with respect to the third housing”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the third housing of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a third delivery device with a third blood collection tube holder configured to slide in unison with respective to the third housing is a simple combination of known elements. The third blood collection tube holder and third tubular instrument perform its known function (i.e., advancement and blood collection), without changing the fundamental principle of operation.
Regarding claim 17, Burkholz does not specifically teach “wherein the distal end of the third tubular instrument comprises a plurality of side holes”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the third housing of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a third tubular instrument with a plurality of side holes, is a simple combination of known elements. The third tubular instrument with a plurality of side holes performs its known function (i.e., facilitate blood flow into the catheter) without changing the fundamental principle of operation.
Regarding claim 18, Burkholz does not specifically teach “wherein the distal end of the third housing comprises an adapter configured to couple to the catheter assembly”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the third housing of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a third housing comprising an adapter configured to couple to the catheter assembly, is a simple combination of known elements. The third housing comprising an adapter configured to couple to the catheter assembly performs its known function (i.e., connection with the catheter to facilitate blood flow into the catheter) without changing the fundamental principle of operation.
Regarding claim 19, Burkholz illustrates (Fig. 2G) wherein the first housing (28) comprises a first marking (53) representative of a first time of use for the first delivery device (10).
Burkholz does not specifically teach “the second housing comprises a second marking representative of a second time of use for the second delivery device, and the third housing comprises a third marking representative of a third time of use for the second delivery device, wherein each of the first, second, and third markings are different”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second housing of the second tubular instrument and the third housing of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a first housing comprising a first marking representative of a first time of use for the first delivery device and the second housing comprising a second marking representative of a second time of use for the second delivery device and the third housing comprising a third marking representative of a third time of use for the third delivery device, is a simple combination of known elements. The first housing comprising a first marking performs its known function (i.e., representing a first time of use for the first delivery device), the second housing comprising a second marking performs its known function (i.e., representing a second time of use for the second delivery device), and the third housing comprising a third marking performs its known function (i.e., representing a third time of use for the third delivery device) without changing the fundamental principle of operation.
Regarding claim 20, Burkholz does specifically not teach “wherein the third tubular instrument is longer than the second tubular instrument by 0.5 inches or less”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the third tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Providing a second delivery device of length X and a third delivery device of length Y (where Y > X), both configured to attach to the same standard catheter hub, is a simple combination of known elements. The second device performs its known function (i.e., shorter deployment), and the third performs its known function (i.e., longer deployment) without changing the fundamental principle of operation.
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Devgon (US 20170360345).
Regarding claim 5, Burkholz does not teach “wherein the distal end of the first tubular instrument and the distal end of the second tubular instrument are each closed”.
Devgon, in a related field of endeavor, teaches (Fig. 31) an apparatus for performing phlebotomy wherein the distal end of the first tubular instrument is closed. (Paragraph [0111]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Burkholz to teach “wherein the distal end of the first tubular instrument [is] closed”. Doing so enables the probe to be moved through clots existing within a peripheral intravenous line. (Paragraph [0111]).
However, Burkholz as modified by Devgon does not specifically teach “wherein the distal end of the second tubular instrument [is] each closed”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a second tubular instrument with a closed distal end is a simple combination of known elements. The second tubular instrument with a closed distal end performs its known function (i.e., smooth insertion; reduce drag and resistance when passing through a medium) without changing the fundamental principle of operation.
Regarding claim 16, Burkholz does not teach “wherein the distal end of the third tubular instrument is closed”.
Devgon, in a related field of endeavor, teaches (Fig. 31) an apparatus for performing phlebotomy wherein the distal end of the tubular instrument is closed. (Paragraph [0111]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Burkholz to teach “wherein the distal end of the [] tubular instrument is closed”. Doing so enables the probe to be moved through clots existing within a peripheral intravenous line. (Paragraph [0111]).
However, Burkholz as modified by Devgon does not specifically teach wherein the distal end of the “third tubular instrument is closed”.
However, as previously discussed, the apparatus merely duplicates a delivery device and alters the physical length of the second tubular instrument. Multi-device kits (e.g., standard central line or blood draw kits) frequently bundle various components of varying lengths and gauges to give clinicians options during a procedure. Hence, providing a third tubular instrument with a closed distal end is a simple combination of known elements. The third tubular instrument with a closed distal end performs its known function (i.e., smooth insertion; reduce drag and resistance when passing through a medium) without changing the fundamental principle of operation.
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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