DETAILED ACTION
This action is responsive to Applicant’s Remarks filed 19 March 2026. The Examiner acknowledges the amendments to the specification and drawings, as well as the lack of amendments to the claims. Claims 1, 4-9, and 22-25 are pending.
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 Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-9, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US-20080086085-A1, previously presented) in view of Lutkowski (US-4416290-A, previously presented).
Regarding claim 1, Brown teaches
A blood collection device to prime a blood flow path, comprising:
a cannula comprising a proximal end, a distal end, and a lumen extending along a longitudinal axis therebetween [the front cannula 130 and the first rear cannula 140 may be integrated together in the form of a single elongated cannula with front and rear portions (Brown ¶0068, Fig. 2), wherein the front portion defined by front cannula 130 is considered to define a distal end of the single elongated cannula, and wherein the rear portion defined by rear cannula 140 is considered to define a proximal end of the single elongated cannula];
a holder comprising a proximal end, a distal end, and a channel extending therebetween, the channel configured to align with the longitudinal axis to retain a shaft of the cannula [A fluid passage 110 within the central body 100 may communicate with, and in the embodiment shown, be connected to, the front cannula 130 and the first rear cannula 140, respectively, using adhesive, threaded interfaces, pressure fit, or other connection means… the fluid passage 110 may be eliminated and the front cannula 130 and the first rear cannula 140 may be integrated together in the form of a single elongated cannula with front and rear portions (Brown ¶0068), wherein space defined by fluid passage 110 configured to hold the single elongated cannula is considered to define the claimed channel and will hereafter be referred to as fluid passage 110], the holder comprising a visual check window [all, or portions, of the central body 100 may be transparent, translucent (Brown ¶0032)]; and
an elastomeric sleeve coupled to the holder and enclosing the proximal end of the cannula [The sleeve 150 may isolate the rear cannula 140 from the ambient, wherein the ambient includes any space outside of the sleeve 150 (Brown ¶0030, Fig. 2)].
However, while Brown discloses forming each of the holder and the single elongated cannula from transparent or translucent material to visualize a blood flow path through the cannula [It is also appreciated that the front and/or rear cannulae may be transparent or translucent, in whole or part, to provide flash detection in alternative embodiments of the present invention (Brown ¶0031); Brown ¶0032], Brown fails to explicitly disclose wherein the cannula comprising a slot to enable a user to visualize a blood flow path through the cannula, wherein the visual check window corresponds to the slot of the cannula. Furthermore, Brown fails to explicitly disclose within a singular embodiment wherein a priming opening is disposed between the elastomeric sleeve and the holder to prime the blood flow path, wherein the priming opening comprises one or more priming slots depressed into a proximal face of the proximal end of the holder in a transverse direction relative to the longitudinal axis, and wherein the elastomeric sleeve seals the priming opening by contacting the proximal face of the holder in response to a blood collection tube being coupled to the holder.
Brown does disclose in a separate embodiment a venting path defined by a priming opening disposed between an elastomeric sleeve and a holder comprises one or more priming slots depressed into a proximal face of a proximal end of a holder in a transverse direction relative to a longitudinal axis through the holder [The bottom surface of the well 117 located within the interior of the guide tube 116 may include a shoulder 119 against which a venting member 160 is disposed. The shoulder 119 may create an air space 161 between the bottom surface of the well 117 and the venting member 160… as shown in FIG. 19, the shoulder may be replaced by a surface having raised radial lines 219, or some other surface which both supports the venting member 160 and provides for air flow between the venting member and the interior of the guide tube 116 (Brown ¶0072, Fig. 19)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brown to employ a priming opening disposed between the elastomeric sleeve and the holder to prime the blood flow path, wherein the priming opening comprises one or more priming slots depressed into a proximal face of the proximal end of the holder in a transverse direction relative to the longitudinal axis, so as to facilitate air priming out of the cannula. Wherein based on the § 103 modification, the priming opening comprising one or more priming slots are considered to be disposed on a proximal face of the portion of central body 100 that extends from the central body 100 and comprises threads 114, similar to how shoulder 119/raised radial lines 219 are configured in Brown Fig. 19.
Lutkowski discloses a blood collection device to prime a blood flow path, wherein Lutkowski discloses a holder [the combination of hub assembly 12 and rear housing portion 14 (Lutkowski Figs. 1-3)] comprising a channel configured to retain a shaft of the cannula [a bore 19 for receiving a negative pressure cannula 28 therein (Lutkowski Col 2:66-68); The remaining parts of the assembly of FIG. 3 are the same as those shown and described in FIG. 1 (Lutkowski Col 3:64-66), such that while bore 19 is not explicitly identified in Fig. 3, bore 19 is considered to hold cannula 60], wherein the holder comprising a visual check window corresponding to a slot of the cannula [annular housing 22 (see Lutkowski Col 3:36-39); In order to provide communication between the cannula 60 and chamber 48 defined by the transparent annular housing 22, a slot 66 is formed in cannula 60 (Lutkowski Col 3:59-62, Fig. 3); The user will observe that such penetration has taken place because blood will be indicated in the translucent or transparent chamber 48 defined by the annular housing 22 (Lutkowski Col 3:36-39)]. Lutkowski further discloses an elastomeric sleeve configured to seal a priming opening of the holder defined between the elastomeric sleeve and a proximal face of the holder by contacting the proximal face of the holder in response to a blood collection tube being coupled to the holder [assembly 10 is shown with an evacuated tube holder 54 received on the helical turns 20 of rear extension 18. Received in holder 54 in conventional manner is an evacuated tube 50, the stopper 52 of which has been penetrated by the point 44 of negative pressure cannula 28, in the usual manner. As can be seen, further, in FIG. 2, front face 39 of stopper 52 has engaged and caused the collapse of rubber sleeve 40. This engagement has urged flange 42 of sleeve 40 against the rear face 31 of rear extension 18 closing passage 29, and front face 33 of flange 42 covers the exit end of filter 30 (Lutkowski Col 3:20-31, Fig. 2)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brown to employ wherein the cannula comprises a slot to enable a user to visualize a blood flow path through the cannula, as this modification would amount to mere simple substitution of one known element [transparent or translucent section of the cannula (Brown ¶0031)] for another [slot in the cannula (Lutkowski Col 3:59-62, Fig. 3)] with similar expected results [visualize flashback] [MPEP § 2143(I)(B)]. The Examiner notes that as the device of Brown comprises a transparent or translucent holder [Brown ¶0032], the visual check window is considered to correspond to the modified slot.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brown to employ wherein the elastomeric sleeve seals the priming opening by contacting the proximal face of the holder in response to a blood collection tube being coupled to the holder to maintain sterility of any blood collected in the blood collection tube by preventing exposure to the ambient environment.
Regarding claim 4, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein the holder is configured to couple to the blood collection tube such that the proximal end of the cannula and the elastomeric sleeve extend through a distal end of the blood collection tube [Brown Fig. 4].
Regarding claim 5, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein the holder further comprises a projection extending from the proximal end of the holder along the longitudinal axis [wherein the portion of central body 100 comprising threads 114 is considered to define a projection from the central body 100 (Brown Fig. 3)].
Regarding claim 6, Brown in view of Lutkowski teaches
The blood collection device of claim 5, wherein the projection forms at least a portion of the channel [Brown Fig. 3].
Regarding claim 7, Brown in view of Lutkowski teaches
The blood collection device of claim 5, wherein the projection comprises the priming opening [see § 103 modification of claim 1 above; Brown Figs. 3, 19].
Regarding claim 8, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein the holder is configured to couple to a needleless connector [A variation of the embodiment of the present invention shown in FIG. 5A is shown in FIG. 5B, in which the butterfly needle 180 is replaced by a front cannula 130 connected directly to the Luer-type hub 102. The Luer-type hub 102 is adapted to connect to the Luer-type central body 100 in accordance with known methods (Brown ¶0047)].
Regarding claim 9, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein the holder comprises a contact interface for physical manipulation of the cannula [The central body 100 may include an annular ring 104, radiating fins 105, or like features, extending from the central body and which may be adapted to aid a user in handling the device 10 (Brown ¶0031)].
Regarding claim 22, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein the proximal face is substantially planar [Brown Figs. 3, 19].
Regarding claim 23, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein each of the one or more priming slots is substantially linear [see Brown Fig. 19, wherein the spaces between the raised radial lines are considered to extend linearly in the transverse direction].
Regarding claim 24, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein each of the one or more priming slots extends from the channel to an outer edge of the holder [Brown Figs. 16-17, 19].
Regarding claim 25, Brown in view of Lutkowski teaches
The blood collection device of claim 1, wherein each of the one or more priming slots extends across an entire length of the proximal face [Brown Fig. 19].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks, filed 19 March 2026, with respect to previously presented drawing objections have been fully considered and are persuasive. The objections regarding reference characters being included in the specification but not the drawings, and reference characters being included in the drawings but not the specification have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 6-9, with respect to the previously applied rejections under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that neither Brown nor Lutkowski disclose or suggest any such “sterility” rationale, and notes that as the Examiner has failed to cite any portion of either reference providing such teachings or suggestions, the stated obviousness rationale is pure conjecture and does not satisfy a prima facie case of obviousness. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Brown is generally directed towards air priming while maintaining sterility [A venting member may be provided near the juncture of the well and the flexible sleeve. The venting member may permit the passage of air through it, but be substantially impermeable to liquids, such as blood (Brown Abstract)], wherein as Brown discloses that the venting member 160 [Examiner cited Brown ¶0072 and Fig. 19 on p. 5-6 of the Non-Final Rejection dated 26 November 2025 regarding the venting member 160] as being “at least partially impermeable to a liquid” [the venting member 160 may be gas, and particularly air, permeable, but at least partially impermeable to a liquid, such as blood (Brown ¶0033)] and as Lutkowski discloses systems for sealing a porous member [Lutkowski Col 3:20-31, Fig. 2], the obviousness rationale “to maintain sterility of any blood collected in the blood collection tube by preventing exposure to the ambient environment” [p. 7 of Non-Final Rejection dated 26 November 2025] is considered to be applicable.
The Applicant further asserts that Brown expressly teaches away from sealing the shoulder (119) and Brown discloses that the venting member (160) provides an air/gas permeable member for air to exit the cannula and sleeve (150) [Brown ¶¶0033, 0074]. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that while the venting member 160 does provide an air/gas permeable member for air to exit the cannula and sleeve (150), the venting member 160 is configured to be sequentially blocked after blood has reached the venting member 160 [After fluid fills the blood drawing device 10 and reaches the venting member 160, fluid leakage past the venting member may be prevented or reduced because the venting member may be at least partially impermeable to liquids, such as blood (Brown ¶0037, Fig. 3); As the container 170 is pushed further into the guide tube 116, the tapered end 142 of the rear cannula presses into and pierces both the flexible sleeve 150 and the stopper 172. The flexible sleeve is pushed down towards, and may gather around, the venting member 160, as shown in FIG. 4 (Brown ¶0039, Fig. 4), wherein the Examiner notes that the flow path as depicted in Fig. 3 defining the air priming is blocked by sleeve 150 when a container 170 is coupled to the device 10].
The Applicant also asserts that sealing the shoulder (119) and resulting air space (161), as proposed by the Examiner, renders the venting member (160) inoperable for exiting air flow [Brown ¶0043], as the air flow provided by the venting member (160) reduces air backpressure in the device that prevents blood flow and collection, such that the proposed modification does not provide a reasonable expectation of success for a prima facie case of obviousness. However, the Examiner disagrees with the Applicant’s argument for similar reasons as discussed by the Examiner above with respect to the Applicant’s second argument [Brown ¶¶0037, 0039, Figs. 3-4, wherein the Examiner notes that the flow path as depicted in Fig. 3 defining the air priming is blocked by sleeve 150 when a container 170 is coupled to the device 10, such that the flow path that may be defined through the shoulder 119 and air space 161 is similarly considered to be blocked upon coupling the container 170].
The Applicant asserts that Brown does not disclose that the blood collection fluid path through the device [cannula (130) to rear cannula (140)] is under vacuum, and notes that Brown instead discloses that there will be air in the device fluid path, and that the venting member (160) provides an exit for any air in the device, while preventing blood from escaping [Brown ¶¶0033, 0074]. The Applicant further notes that blood collected through the device of Brown necessarily and inherently includes “exposure to the ambient environment” via the venting member (160), such that even in the Examiner’s proposed modification based on Lutkowski to seal the venting member (160) and shoulder (119) would not achieve the stated goal of preventing a sample from “exposure to the environment”. However, the Examiner disagrees with the Applicant’s argument for similar reasons to the Examiner’s response to the Applicant’s first argument, as the Examiner acknowledges that Brown is directed towards generally directed towards air priming while maintaining sterility [Brown Abstract], wherein sterility/exposure to the environment in the context of Brown is understood to refer to preventing blood from escaping past allowed sections of the invention [see Brown ¶¶0037, 0039, Figs. 3-4]. As such, the modification of Brown in view of Lutkowski is considered to be applicable for the purpose of further preventing blood from escaping past certain sections of the device of Brown.
Regarding claim 5, the Applicant asserts that the threads (114) on the central body (100) of Brown extend laterally from the side surface of the central body (100), and thus do not extend from the proximal end or extend along the longitudinal axis as claimed. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that the section extending from central body 100 that defines the threads 114 is considered to extend longitudinally from a proximal end of the central body 100.
Regarding claim 6, the Applicant asserts that the threads (114) [projection] on the central body (100) of Brown do not form any portion of the fluid passage (110) [channel] as claimed. However, the Examiner disagrees with the Applicant’s argument and directs attention to p. 5-6 of the Non-Final Rejection dated 26 November 2025 regarding the modification of Brown in light of the identified embodiments of Brown [It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brown to employ a priming opening disposed between the elastomeric sleeve and the holder to prime the blood flow path, wherein the priming opening comprises one or more priming slots depressed into a proximal face of the proximal end of the holder in a transverse direction relative to the longitudinal axis, so as to facilitate air priming out of the cannula. Wherein based on the § 103 modification, the priming opening comprising one or more priming slots are considered to be disposed on a proximal face of the portion of central body 100 that extends from the central body 100 and comprises threads 114, similar to how shoulder 119/raised radial lines 219 are configured in Brown Fig. 19 (p. 6 of the Non-Final Rejection dated 26 November 2025); see also Brown ¶72, Fig. 19], such that the raised radial lines 219 of shoulder 119 are considered to be positioned on the projection as identified in the rejection of claim 5 [p. 8 of the Non-Final Rejection dated 26 November 2025] and the Examiner’s response to the Applicant’s argument against the rejection of claim 5 above.
Regarding claim 7, the Applicant asserts that the threads (114) on the central body (100) do not comprise any portion of the modified shoulder (119) [priming opening] as claimed. However, the Examiner disagrees with the Applicant’s argument for the same reasons as outlined in the Examiner’s response to the Applicant’s argument against claim 6 above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791
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