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
Claim 19 is objected to because of the following informalities: "the second conduit portion comprise one or more protrusions extending from a sidewall thereof at or near the proximal end thereof." should read "the second conduit portion comprise as is similarly recited in the previous limitation. Appropriate correction is required.
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.
Claim(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (Pub. No. US 20200316346 A1, herein Burkholz) in view of Burkholz et al. (Pub. No. US 20190321590 A1, herein Burkholz '590).
Regarding Claim 1, Burkholz discloses a blood draw device for withdrawing blood through an intravenous catheter assembly (Abstract), the blood draw device (Fig. 7A) comprising:
a housing (50);
a fluid conduit (48 which includes a fluid permeable structure, 64, allowing blood flow, Paragraph [0085]) displaceably received within the housing (Fig. 1D-1E, Paragraph [0083]) and having a proximal end (58) and a distal end (60), the fluid conduit comprising:
a first conduit portion (110) at the proximal end of the fluid conduit (Fig. 7B), the first conduit portion having a proximal end (112), a distal end (114), and a first diameter (widest section of 110 in Fig. 7B); and
a second conduit portion (102) at the distal end of the fluid conduit (Fig. 7B), the second conduit portion having a proximal end (104), a distal end (106),
wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter (14) of the intravenous catheter assembly (Fig. 1D, Paragraph [0083]) to a second, distal position in which the second conduit portion extends beyond a distal end of a catheter of the intravenous catheter assembly (Fig. 1E, Paragraph [0114]).
Burkholz does not expressly disclose wherein the second conduit portion has a second diameter different from the first diameter.
Burkholz ‘590 teaches wherein the second conduit portion (28) has a second diameter different from the first diameter (Annotated Fig. 1B below).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by Burkholz wherein the second conduit portion has a second diameter different from the first diameter as taught by Burkholz ‘590 so that there may be an improved blood flow rate during blood collection (Burkholz ‘590, Paragraph [0056]).
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Regarding Claim 2, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1, wherein the first diameter is larger than the second diameter (Burkholz ‘590, Annotated Fig, 1B).
It would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz wherein the first diameter is larger than the second diameter as taught by Burkholz ‘590 so that there may be an improved blood flow rate during blood collection (Burkholz ‘590, Paragraph [0056]).
Regarding Claim 3, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1, wherein the distal end of the first conduit portion overlaps the proximal end of the second conduit portion (Burkholz ‘590, at 32 in Annotated Fig. 1B).
It would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz wherein the distal end of the first conduit portion overlaps the proximal end of the second conduit portion as taught by Burkholz ‘590 so that a blood collection time is reduced (Burkholz ‘590, Paragraph [0063]).
Regarding Claim 4, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 3, wherein the first conduit portion includes at the distal end thereof, a proximal to distal taper to a smaller diameter (Burkholz ‘590, Fig. 8, Paragraph [0043]).
It would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz wherein the first conduit portion includes at the distal end thereof, a proximal to distal taper to a smaller diameter as taught by Burkholz ‘590 so that a blood collection time is reduced (Burkholz ‘590, Paragraph [0063]).
Regarding Claim 21, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 does not expressly disclose wherein the second conduit portion comprises one or more openings in a sidewall thereof at or near the distal end thereof.
In a differing embodiment, Burkholz discloses wherein the second conduit portion (118) comprises one or more openings (120) in a sidewall thereof at or near the distal end thereof (Fig. 7E, Paragraph [0115]).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as depicted by the embodiment of Burkholz in Fig. 7B so that the second conduit portion comprises one or more openings in a sidewall thereof at or near the distal end thereof as depicted by the embodiment of Burkholz in Fig. 7E so that material may not obstruct the distal tip of the catheter (Burkholz, Paragraph [0087]).
Regarding Claim 22, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1, further comprising a third conduit portion arranged at the distal end of the second conduit portion (Burkholz, portion of distal end 60 closest to a rounded tip 72, Figs. 1G, 1H), the third conduit portion comprising one or more openings in a sidewall thereof (Burkholz, distal end 60 is fluid permeable, Paragraph [0085], distal end 60 then has openings for fluid to permeate through, Fig. 1H).
Regarding Claim 23, Modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 22, wherein the third conduit portion comprises a rounded distal end (Burkholz, 72, Fig. 7E).
Regarding Claim 24, Burkholz discloses a catheter system (Abstract) comprising:
a catheter assembly (10, Fig, 1A) comprising:
a catheter adapter (16), comprising a distal end (18), a proximal end (20), a lumen (22) extending between the distal end and the proximal end (Fig. 1E, Paragraph [0076]); and
a catheter (24) secured to the catheter adapter and extending distally from the catheter adapter (Paragraph [0076]), wherein the catheter comprises a distal end (end furthest from the catheter adapter in Fig. 1D) and a proximal end (end attached to catheter adapter in Fig. 1D); and
a blood draw device for withdrawing blood through an intravenous catheter assembly (Abstract), the blood draw device (Fig. 7A) comprising:
a housing (50); a fluid conduit (48 which includes a fluid permeable structure, 64, allowing blood flow, Paragraph [0085]) displaceably received within the housing (Fig. 1D-1E, Paragraph [0083]) and having a proximal end (58) and a distal end (60), the fluid conduit comprising:
a first conduit portion (110) at the proximal end of the fluid conduit (Fig. 7B), the first conduit portion having a proximal end (112), a distal end (114), and a first diameter (widest section in Fig. 7B); and
a second conduit portion (102) at the distal end of the fluid conduit (Fig. 7B), the second conduit portion having a proximal end (112), a distal end (106),
wherein the fluid conduit is configured to be advanced from a first, proximal position in which the second conduit portion does not extend beyond a distal end of a catheter (14) of the intravenous catheter assembly (Fig. 1D, Paragraph [0083]) to a second, distal position in which the second conduit portion extends beyond a distal end of a catheter of the intravenous catheter assembly (Fig. 1E, Paragraph [0114]).
Burkholz does not expressly disclose wherein the second conduit portion has a second diameter different from the first diameter.
Burkholz ‘590 teaches wherein the second conduit portion (28) has a second diameter different from the first diameter (Annotated Fig. 1B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by Burkholz wherein the second conduit portion has a second diameter different from the first diameter as taught by Burkholz ‘590 so that there may be an improved blood flow rate during blood collection (Burkholz ‘590, Paragraph [0056]).
Claim(s) 5-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Burkholz '590 further in view of Porter et al. (US RE47154 E, herein Porter).
Regarding Claim 5, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 3.
Modified Burkholz in view of Burkholz ‘590 does not expressly disclose wherein the first conduit portion is joined to the second conduit portion by an adhesive, a weld, and/or by overmolding.
Porter teaches wherein the first conduit portion (12) is joined to the second conduit portion (14) by an adhesive (connector sleeve 44 is joined to conduit 14 via curable glue or adhesive, Col. 14 Lines 54-60, Fig. 2B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by modified Burkholz in view of Burkholz ‘590 wherein the first conduit portion is joined to the second conduit portion by an adhesive as taught by Porter so that structure may be removable without damage (Porter, Col. 2 Lines 25-29).
Regarding Claim 6, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 does not expressly disclose wherein the first conduit portion is joined to the second conduit portion with a stent.
Porter teaches wherein the first conduit portion (12) is joined to the second conduit portion (14) with a stent (“the connector sleeve 44 comprises a tubular lattice structure similar to a stent that is crimped onto the connector system” – Col. 14 Lines 60-67).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by modified Burkholz in view of Burkholz ‘590 wherein the first conduit portion is joined to the second conduit portion with a stent as taught by Porter so that the fluid conduit is flexible.
Regarding Claim 7, modified Burkholz in view of Burkholz ‘590 and Porter teaches the blood draw device of claim 6, wherein the stent (Porter, 44) is formed of nitinol (Porter, Col. 14 Lines 63-67).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the stent is formed of nitinol as taught by Porter so that the stent is able to expand and reduce in diameter in response to temperature (Porter, Col. 14 Lines 63-67).
Regarding Claim 8, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 6, wherein the stent (Porter, 44) is joined to the first conduit portion (Porter, 12) and/or the second conduit portion (Porter, 14) by an adhesive and/or a weld (Porter, Col. 14 Lines 54-67).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the stent is joined to the first conduit portion and/or the second conduit portion by an adhesive and/or a weld as taught by Porter so that structure may be removable without damage (Porter, Col. 2 Lines 25-29).
Regarding Claim 9, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 6, wherein the stent (Porter, 44) is arranged about an outer surface of the first conduit portion (Porter, 12) and the second conduit portion (Porter, Col. 14 Lines 61-63, Fig. 2B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the
invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the stent is arranged about an outer surface of the first conduit portion and the second conduit portion as taught by Porter so that there may be a radially inward force to the conduit portions (Porter, Col 14 Lines 66-67).
Regarding Claim 10, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 6.
Modified Burkholz in view of Burkholz ‘590 and Porter does not expressly disclose wherein the stent is received within the first conduit portion and the second conduit portion.
Porter teaches the blood draw device of claim 6, wherein the stent is arranged about an outer surface of the first conduit portion and the second conduit portion (Porter, Col. 14 Lines 61-63, Fig. 2B).
It would have been obvious to one of ordinary skill within the art at the time of the invention to modify the device as disclosed by Burkholz in view of Burkholz ‘590 so that the stent is arranged about an outer surface of the first conduit portion and the second conduit portion as taught by Porter in order to provide a reduced desirable diameter (Porter, Col. 14 Lines 29-33).
Regarding Claim 11, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 does not expressly disclose wherein the first conduit portion is joined to the second conduit portion with a double-sided wedge.
Porter teaches wherein the first conduit portion (12) is joined to the second conduit portion (14) with a double-sided wedge (222 being a wedge-shaped connector joining each fluid conduit Fig. 28A-B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the first conduit portion is joined to the second conduit portion with a double-sided wedge as taught by Porter so that the connector is easily removable (Porter, Col. 2 Lines 25-29).
Regarding Claim 12, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 11, wherein the double-sided wedge (Porter, 222) comprises a first frustoconical end received within the first conduit portion (Porter, side connected to first conduit portion 12 in Figs. 28A-28B) and a second frustoconical end received within the second conduit portion (Porter, side connected to second conduit portion 14 Figs. 28A-28B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the double-sided wedge comprises a first frustoconical end received within the first conduit portion and a second frustoconical end received within the second conduit portion as taught by Porter so that turbulent flow is minimized (Porter, Col. 35 Lines 7-11).
Regarding Claim 13, modified Burkholz in view of Burkholz’ 590 and Porter discloses the blood draw device of claim 11, the double-sided wedge (Porter, 222) is joined to the first conduit portion (Porter, 12) and/or the second conduit portion (Porter, 14) by an adhesive and/or a weld (Porter, Col. 2 Lines 25-29).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the double-sided wedge is joined to the first conduit portion and/or the second conduit portion by an adhesive and/or a weld as taught by Porter so that the connector is easily removable (Porter, Col. 2 Lines 25-29).
Regarding Claim 14, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 does not expressly disclose wherein the first conduit portion is joined to the second conduit portion with a bushing having a proximal end and a distal end.
Porter teaches wherein the first conduit portion (14) is joined to the second conduit portion (12) with a bushing having a proximal end and a distal end (bushing comprised of connector 2 and sleeve 44, proximal end of bushing at first end 4, distal end on second end 8, Figs. 2A and 2B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the first conduit portion is joined to the second conduit portion with a bushing having a proximal end and a distal end as taught by Porter so that the connector is easily removable (Porter, Col. 2 Lines 25-29).
Regarding Claim 15, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 14, wherein the proximal end of the bushing is received within the first conduit portion (Porter, end 4 is received by 12, Fig. 2A-B), and the distal end of the bushing is arranged about an outer surface of the second conduit portion (Porter, 44 forming around 14, Fig. 2A-B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the proximal end of the bushing is received within the first conduit portion, and the distal end of the bushing is arranged about an outer surface of the second conduit portion as taught by Porter so that the connector is easily removable (Porter, Col. 2 Lines 25-29).
Regarding Claim 16, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 14, wherein the bushing further comprises one or more flanges (Porter, middle portion 6, comprising a central flange 38), and wherein the distal end of the first conduit portion abuts the one or more flanges (Porter, 12 contacts and abutted by 6 in Fig.2B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the bushing further comprises one or more flanges, and wherein the distal end of the first conduit portion abuts the one or more flanges as taught by Porter so that damage or loss of the connector is prevented (Porter, Col. 13 Lines 42-45).
Regarding Claim 17, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 14.
Modified Burkholz in view of Burkholz ‘590 and Porter does not expressly disclose wherein at least a portion of an inner diameter of the bushing is the same as the second diameter.
It would have been an obvious matter of design choice to modify at least a portion of an inner diameter of the bushing is the same as the second diameter, since such modification would have involved a mere change in size of a component. A change in size is generally recognized as being within the level of ordinary skill within the art. In re Rose, 105 USPQ 237 (CCPA 1955). The motivation being that a smooth transition in diameters may reduce turbulent flow (Porter, Col. 10 Lines 49-52).
Regarding Claim 18, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 14, wherein the bushing is joined to the first conduit portion and/or the second conduit portion by an adhesive and/or a weld (Porter, Col. 14 Lines 54-60).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the Invention to modify the blood draw device as disclosed by Burkholz wherein the bushing is joined to the first conduit portion and/or the second conduit portion by an adhesive and/or a weld as taught by Porter so that the connector is easily removable (Porter, Col. 2 Lines 25-29).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Burkholz '590 further in view of Burkholz et al. (US 10238852 B2, herein Burkholz '852).
Regarding Claim 19, modified Burkholz in view of Burkholz ‘590 discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 does not expressly disclose wherein:
the first conduit portion comprises one or more openings in a sidewall thereof at or near the distal end thereof; and
the second conduit portion comprise one or more protrusions extending from a sidewall thereof at or near the proximal end thereof.
Burkholz ‘852 teaches wherein:
the first conduit portion comprises one or more openings in a sidewall thereof at or near the distal end thereof (groove 30 of catheter adapter 14 can be an opening 70, Fig. 1A-1B, Col. 6 Lines 45-49); and
the second conduit portion comprise one or more protrusions extending from a sidewall thereof at or near the proximal end thereof (lip 34 in Fig. 1B).
Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein: the first conduit portion comprises one or more openings in a sidewall thereof at or near the distal end thereof; and the second conduit portion comprise one or more protrusions extending from a sidewall thereof at or near the proximal end thereof as taught by Burkholz ‘852 so that the conduits are able to be removable (Burkholz ‘852, Col. 6 Lines 41-44).
Regarding Claim 20, modified Burkholz in view of Burkholz ‘590 and Burkholz ‘852 discloses the blood draw device of claim 19, wherein the one or more protrusions are received within the one or more openings, thereby locking the first conduit portion to the second conduit portion (Burkholz ‘852, Col. 6 Lines 45-51).
It would be obvious to one of ordinary skill in the art at the time of the invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the one or more protrusions are received within the one or more openings, thereby locking the first conduit portion to the second conduit portion as taught by Burkholz ‘852 so that the conduits are able to be removable (Burkholz ‘852, Col .6 Lines 41-44).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm, Alt. Friday off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783