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 .
This action is in response to the Applicant’s amendment filed April 20, 2026.
Claims 1, 6, 11, 14, 19, and 24 are currently amended.
Claims 3-5, and 9 are cancelled.
Claims 1, 2, 6-8, and 10-24 are being examined in this Office Action.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 6-8, 10-18, and 21-24 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) further in view of Porter et al. (US RE47154 E, herein Porter).
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 (see 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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Burkholz also does not expressly disclose wherein the distal end of the first conduit portion is joined to the proximal end of the second conduit portion by a joining device, the joining device received within at least a portion of the first conduit portion.
Porter teaches wherein the distal end of the first conduit portion (12) is joined to the proximal end of the second conduit portion (14) by a joining device (44 with integrated strain relief structure 54, Col. 15 Lines 57-60), the joining device received within at least a portion of the first conduit portion (“the strain relief structure typically comprises a flexible spiral or coil that extends from an end of the connector 2 or connector sleeve 44 and onto the outer surface of or within the wall of the conduit/graft 12.” – Col. 21 Line 66 through Col. 22 Line 4).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood draw device disclosed by modified Burkholz in view of Burkholz ‘590 wherein the distal end of the first conduit portion is joined to the proximal end of the second conduit portion by a joining device, the joining device received within at least a portion of the first conduit portion so that conduits may be removed without damage to each outer (Porter, Col. 2 Line 25-28).
Regarding Claim 2, modified Burkholz in view of Burkholz ‘590 and Porter 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 before the effective filing date of the claimed invention to modify the blood draw device as disclosed by Burkholz and Porter 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 6, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 1, wherein the joining device is a stent (Porter, “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 before the effective filing date of the claimed invention to modify the blood draw device as disclosed by modified Burkholz in view of Burkholz ‘590 wherein the joining device is a stent as taught by Porter so that the stent is flexible (Porter, Col. 14 Lines 63-67).
Regarding Claim 7, modified Burkholz in view of Burkholz ‘590 and Porter discloses 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 before the effective filing date of the claimed 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 10, modified Burkholz in view of Burkholz ‘590 and Porter discloses 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 before the effective filing date of the claimed 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 and Porter discloses the blood draw device of claim 1, wherein the joining device is a double-sided wedge (Porter, 222 being a wedge-shaped connector joining each fluid conduit, Figs. 28A-B).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 wherein the joining device is 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 and Porter discloses the blood draw device of claim 1, wherein the joining device is a bushing having a proximal end and a distal end (Porter, 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).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood draw device disclosed by modified Burkholz in view of Burkholz ‘590 wherein the joining device is 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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.
However, 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 before the effective filing date of the claimed 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).
Regarding Claim 21, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 Porter 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 before the effective filing date of the claimed 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 and Porter 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 and Porter 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 before the effective filing date of the claimed 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]).
Burkholz also does not expressly disclose wherein the distal end of the first conduit portion is joined to the proximal end of the second conduit portion by a joining device, the joining device received within at least a portion of the first conduit portion.
Porter teaches wherein the distal end of the first conduit portion (12) is joined to the proximal end of the second conduit portion (14) by a joining device (44 with integrated strain relief structure 54, Col. 15 Lines 57-60), the joining device received within at least a portion of the first conduit portion (“the strain relief structure typically comprises a flexible spiral or coil that extends from an end of the connector 2 or connector sleeve 44 and onto the outer surface of or within the wall of the conduit/graft 12.” – Col. 21 Line 66 through Col. 22 Line 4).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood draw device disclosed by modified Burkholz in view of Burkholz ‘590 wherein the distal end of the first conduit portion is joined to the proximal end of the second conduit portion by a joining device, the joining device received within at least a portion of the first conduit portion so that conduits may be removed without damage to each outer (Porter, Col. 2 Line 25-28).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Burkholz '590 and Porter, further in view of Burkholz et al. (US 10238852 B2, herein Burkholz '852).
Regarding Claim 19, modified Burkholz in view of Burkholz ‘590 and Porter discloses the blood draw device of claim 1.
Modified Burkholz in view of Burkholz ‘590 and Porter 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 comprises 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 comprises 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 before the effective filing date of the claimed invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 and Porter 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, Porter, 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 before the effective filing date of the claimed invention to modify the blood draw device as disclosed by Burkholz in view of Burkholz ‘590 and Porter 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).
Response to Arguments
Applicant’s arguments filed April 20, 2026 have been fully considered
In regards to Applicant’s argument that
“Claim 19 is objected to for an informality. Applicant has amended claim 19 in a manner believed to address the objection and respectfully request that the objection to be withdrawn.”
This is persuasive and the objection for claim 19 has been withdrawn.
In regards to Applicant’s argument that
“Applicant has amended independent claims 1 and 24 to recite that the distal end of the first conduit portion is joined to the proximal end of the second conduit portion by a joining device, the joining device received within at least a portion of the first conduit portion.”
This is persuasive and the 35 U.S.C. § 103 Rejection for independent claims 1 and 24 has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Porter.
Conclusion
THIS ACTION IS MADE FINAL. 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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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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