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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/13/2026 has been entered.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 20100317999) (previously cited) in view of Abrahamson (US 5382238) and Westbye (US 20060095010).
Regarding claim 1, Shaw ‘999 teaches a medical device (Fig. 2), comprising: a cap (needle holder 50 with head 54, neck 60); a needle (28) housed in the cap; an actuator (lug ring 62) coupled with at least one of the needle and the luer tube; and a spring (70) operatively associated with the actuator. (Paragraphs [0034]-[0035]).
However, Shaw ’999 does not specifically teach “a luer cap”; a needle housed in “the luer cap”; and “a luer tube having a distal end and a proximal end, wherein the proximal end is open and the distal end is open and attached to a proximal end of the needle such that the luer tube is in fluid communication with the needle in at least a first position and a second position.”
Abrahamson, in a related field of endeavor, teaches a catheter assembly (Fig. 8) comprising a luer cap; a needle housed in the luer cap. (Col. 8, lines 20-30, luer connectors 64 and 66, include needle pierceable diaphragms, that serve as connectors for connecting the extension members 56 and 58 to various tubes leading to the dialysis unit. The luer connector 64 also receives the threaded cap member 20 of the wire stiffener 12).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap of Shaw ‘999 to be configured as “a luer cap”, wherein a needle is housed in “the luer cap”, such that it is attachable via threaded attachment means to an open end, as taught by Abrahamson. Doing so provides a standard luer connection to the cap, which yields predictable results such as preventing contamination, or ensuring leak-proof fluid transfer.
Westbye, in a related field of endeavor, teaches a syringe device (Fig. 1) comprising a luer tube (luer sheath 44 comprising luer needle 42) having a distal end and a proximal end (see Fig. 1), wherein the proximal end is open and the distal end is open (see Fig. 1) and attached to a proximal end of the needle (32) such that the luer tube is in fluid communication with the needle in at least a first position (Fig. 3) and a second position (see Fig. 4). (Paragraphs [0015], [0022], [0025]-[0026]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 to provide “a luer tube having a distal end and a proximal end, wherein the proximal end is open and the distal end is open and attached to a proximal end of the needle such that the luer tube is in fluid communication with the needle in at least a first position and a second position”, as taught by Westbye. Doing so provides a safety and containment mechanism to protect or expose the needle as necessitated.
Regarding claim 2, Shaw ‘999 teaches wherein the needle is removably coupleable with the luer tube (56). (Paragraph [0035] a flexible elastomeric sheath 56 having an open end 58 and a closed end 74 is desirably attached, such as by frictional engagement, to head 54 and neck 60 of needle holder 50.)
Regarding claim 3, Shaw ‘999 as modified does not teach “wherein the luer cap comprises an inside surface and wherein the inside surface is threaded”.
Abrahamson teaches wherein the luer cap comprises an inside surface and wherein the inside surface is threaded. (Fig. 8; Col. 8, lines 20-30, luer connectors 64 and 66 that serve as connectors for connecting the extension members 56 and 58 to various tubes leading to the dialysis unit. The luer connector 64 also receives the threaded cap member 20 of the wire stiffener 12).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “wherein the luer cap comprises an inside surface and wherein the inside surface is threaded” as taught by Abrahamson. Doing so provides a mechanism to tightly seal the connection, lowering the risk of accidental slips or leaks.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘999 in view of Abrahamson and Westbye, further in view of Shaw (WO 2014143220) (previously cited).
Regarding claim 4, Shaw ‘999 as modified does not teach “a vacuum collection tube removably coupled to the luer cap.”
Shaw ‘220 teaches a vacuum collection tube (42, 104) removably coupled to the luer cap (70). (see Fig. 4; Paragraph [0018]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “a vacuum collection tube removably coupled to the luer cap” as taught by Shaw ‘220. Doing so provides a container to facilitate collection of the specimen.
Regarding claim 5, Shaw ‘999 as modified does not teach “wherein the vacuum collection tube defines a vacuum chamber.”
Shaw ‘220 teaches wherein the vacuum collection tube defines a vacuum chamber (110). (See Fig. 6).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “wherein the vacuum collection tube defines a vacuum chamber” as taught by Shaw ‘220. Doing so provides a container to facilitate collection of the specimen.
Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘999 in view of Abrahamson and Westbye, further view of Kuracina (WO 9844970) (previously cited).
Regarding claim 6, Shaw ‘999 teaches wherein the vacuum collection tube (42) comprises a distal end; a proximal end opposed from the distal end. (See Fig. 6).
However, Shaw ‘999 does not further teach “a sealing cap positioned over the proximal end; and a septum coupled to the sealing cap”.
Kuracina, in a related field of endeavor, teaches a blood collection apparatus (Fig. 24) comprising a sealing cap (Fig. 21, sealing plug 137) positioned over the proximal end; and a septum (pierceable section 77) coupled to the sealing cap.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “a sealing cap positioned over the proximal end; and a septum coupled to the sealing cap” as taught by Kuracina. Doing so provides enables regulation of the specimen flow through the sealing plug from a needle into the collection container. (Page 19, lines 1-2).
Regarding claim 8, Shaw ‘999 as modified does not teach “wherein the needle is movable between at least a first position and a second position.”
Kuracina teaches wherein the needle is movable between at least a first position (non-advanced position) and a second position (needle is advanced into chamber 268). (Page 47, lines 9-17).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “wherein the needle is movable between at least a first position and a second position” as taught by Kuracina. Doing so facilitates movement for the specimen to flow into a container. (Page 47, lines 15-17).
Regarding claim 9, Shaw ‘999 as modified does not teach “wherein, in the first position, the needle is located below the septum and in the second position, the needle is pierced through the septum and at least partially received within the vacuum chamber.”
Kuracina teaches wherein, in the first position, (Fig. 1), the needle is located below the septum (pierceable section 32 of sealing plug of Fig. 16) and in the second position, (Fig. 2), the needle (21) is pierced through the septum and at least partially received within the vacuum chamber (140). (See Fig. 2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ’999 as modified to provide “wherein, in the first position, the needle is located below the septum and in the second position, the needle is pierced through the septum and at least partially received within the vacuum chamber” as taught by Kuracina. Doing so facilitates movement for the specimen to flow into a container. (Page 47, lines 15-17).
Regarding claim 10, Shaw ‘999 as modified does not teach “wherein, upon piercing through the septum, a vacuum is drawn from the luer tube toward the vacuum chamber.”
Kuracina teaches wherein, upon piercing through the septum, a vacuum is drawn toward the vacuum chamber (140, 143). (see Fig. 2; Page 18, lines 27-30, Page 19, lines 1-5).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “wherein, upon piercing through the septum a vacuum is drawn from the luer tube toward the vacuum chamber” as taught by Kuracina. Doing so facilitates movement for the specimen to flow into a container. (Page 47, lines 15-17).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘999 in view of Abrahamson, Westbye and Kuracina, further in view of Newby (CA 2231063) (previously cited).
Regarding claim 7, Shaw ‘999 as modified does not teach “wherein the sealing cap comprises an outside surface, the outside surface comprising a plurality of ribs”.
Newby, in a related field of endeavor, teaches an assembly for collection bodily fluids comprising a sealing cap (22) wherein the sealing cap (22) comprises an outside surface, the outside surface comprising a plurality of ribs (30).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘999 as modified to provide “wherein the sealing cap comprises an outside surface, the outside surface comprising a plurality of ribs” as taught by Newby. Doing so facilitates facilitate the handling of the cap and assembly. (Page 5, lines 13-14).
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘220 in view of Abrahamson, Westbye and Shaw ‘999.
Regarding claim 11, Shaw ‘220 teaches a system for drawing blood from a patient, (Figs. 1, 4) the system comprising: a catheter hub (32); a catheter tube (barrel 48) in fluid communication with the catheter hub; and a medical device (Fig. 4, apparatus 34) removably coupleable to a portion of the catheter hub (32), (Paragraph [0016]), the medical device comprising: a cap (70); a needle (78) housed in the cap.
However, Shaw ’220 does not specifically teach “a luer cap”; a needle housed in “the luer cap”; “a luer tube having a distal end and a proximal end, wherein the proximal end is open and the distal end is open and attached to a proximal end of the needle such that the luer tube is in fluid communication with the needle in at least a first position and a second position”, and “an actuator coupled with at least one of the needle and the luer tube; and a spring operatively associated with the actuator.”
Abrahamson, as previously discussed, teaches a catheter assembly (Fig. 8) comprising a luer cap; a needle housed in the luer cap. (Col. 8, lines 20-30, luer connectors 64 and 66, include needle pierceable diaphragms, that serve as connectors for connecting the extension members 56 and 58 to various tubes leading to the dialysis unit. The luer connector 64 also receives the threaded cap member 20 of the wire stiffener 12).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap of Shaw ‘999 to be configured as “a luer cap”, wherein a needle is housed in “the luer cap”, such that it is attachable via threaded attachment means to an open end, as taught by Abrahamson. Doing so provides a standard luer connection to the cap, which yields predictable results such as preventing contamination, or ensuring leak-proof fluid transfer.
Westbye, as previously discussed, teaches syringe device (Fig. 1) comprising a luer tube (luer sheath 44 comprising luer needle 42) having a distal end and a proximal end (see Fig. 1), wherein the proximal end is open and the distal end is open and attached to a proximal end of the needle (32) such that the luer tube is in fluid communication with the needle in at least a first position (Fig. 3) and a second position (see Fig. 4). (Paragraphs [0015], [0022], [0025]-[0026]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw to provide “a luer tube having a distal end and a proximal end, wherein the proximal end is open and the distal end is open and attached to a proximal end of the needle such that the luer tube is in fluid communication with the needle in at least a first position and a second position”, as taught by Westbye. Doing so provides a safety and containment mechanism to protect or expose the needle as necessitated.
Shaw ‘999 teaches a medical device (Fig. 2), comprising an actuator (lug ring 62) coupled with at least one of the needle (28) and the luer tube (56); and a spring (70) operatively associated with the actuator. (Paragraphs [0034]-[0035]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 to provide “an actuator coupled with at least one of the needle and the luer tube; and a spring operatively associated with the actuator” as taught by Shaw ‘999. Doing so provides a mechanism that facilitates collection of the bodily fluids from a patient. (Abstract).
Regarding claim 12, Shaw ‘220 teaches wherein the luer tube (72) is removably coupleable with the catheter hub (32) such that they are in fluid communication. (Paragraph [0016]).
Regarding claim 13, Shaw ‘220 teaches wherein the luer tube (72) is removably coupleable with the catheter tube (48) such that they are in fluid communication. (Paragraph [0016]).
Regarding claim 14, Shaw ‘220 teaches wherein the luer tube (72) extends into the catheter tube (48). (Fig. 4)
Regarding claim 15, Shaw ‘220 teaches wherein the luer tube (72) extends into the catheter hub (32). (Fig. 4).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘220 in view of Abrahamson, Westbye and Shaw ‘999, further in view of Raybuck.
Regarding claim 16, Shaw ‘220 as modified does not teach “wherein the medical device is threadedly engageable with a portion of the catheter hub”.
Raybuck teaches wherein the medical device (connector device 30 with body 36) is threadedly engageable (via 152) with a portion of the catheter hub (connector 70). (See Fig. 34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 as modified to provide “wherein the medical device is threadedly engageable with a portion of the catheter hub” as taught by Raybuck. Doing so firmly secures the male connector and female connector devices together. (Page 24, lines 6-10).
Claims 17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘220 in view Abrahamson, Westbye and Shaw ‘999, further in view of Kuracina.
Regarding claim 17, Shaw ‘220 teaches wherein the vacuum collection tube (42) comprises a distal end (104); a proximal end opposed from the distal end (106). (See Fig. 1).
However, Shaw ‘220 as modified does not further teach “a sealing cap positioned over the proximal end; and a septum coupled to the sealing cap”.
Kuracina, in a related field of endeavor, teaches a blood collection apparatus (Fig. 24) comprising a sealing cap (Fig. 21, sealing plug 137) positioned over the proximal end; and a septum (pierceable section 77) coupled to the sealing cap.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 as modified to provide “a sealing cap positioned over the proximal end; and a septum coupled to the sealing cap” as taught by Kuracina. Doing so provides enables regulation of the specimen flow through the sealing plug from a needle into the collection container. (Page 19, lines 1-2).
Regarding claim 19, Shaw ‘220 as modified does not teach “wherein the needle is movable between at least a first position wherein the needle is located below the septum and a second position wherein the needle is pierced through the septum and at least partially received within the vacuum chamber.”
Kuracina teaches wherein the needle is movable between at least a first position (Fig. 1) wherein the needle is located below the septum (pierceable section 32 of sealing plug of Fig. 16) and a second position (Fig. 2) wherein the needle (21) is pierced through the septum and at least partially received within the vacuum chamber (140). (See Fig. 2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 as modified to provide “wherein the needle is movable between at least a first position wherein the needle is located below the septum and a second position wherein the needle is pierced through the septum and at least partially received within the vacuum chamber” as taught by Kuracina. Doing so facilitates movement for the specimen to flow into a container. (Page 47, lines 15-17).
Regarding claim 20, Shaw ‘220 as modified does not teach “wherein the actuator facilitates movement of the needle from the first position and the second position, and wherein the spring facilitates movement of the needle and actuator from the second position to the first position”.
Shaw ‘999 teaches wherein the actuator (lug ring 62) facilitates movement of the needle from the first position and the second position, and wherein the spring (70) facilitates movement of the needle and actuator from the second position to the first position. (Paragraphs [0035], [0038], [0040]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 as modified to provide “wherein the actuator facilitates movement of the needle from the first position and the second position, and wherein the spring facilitates movement of the needle and actuator from the second position to the first position” as taught by Shaw ‘999. Doing so facilitates collection of the bodily fluids from a patient. (Abstract).
Regarding claim 21, Shaw ‘220 as modified does not teach “wherein upon piercing through the septum, a vacuum is drawn from catheter tube toward the vacuum chamber to draw a blood sample from the patient”.
Kuracina teaches wherein upon piercing through the septum, a vacuum is drawn from catheter tube toward the vacuum chamber (140, 143) to draw a blood sample from the patient. (See Fig. 2; Page 18, lines 27-30, Page 19, lines 1-5).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 as modified to provide “wherein upon piercing through the septum, a vacuum is drawn from catheter tube toward the vacuum chamber to draw a blood sample from the patient” as taught by Kuracina. Doing so facilitates movement for the specimen to flow into a container. (Page 47, lines 15-17).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘220 in view of Abrahamson, Westbye, Shaw ‘999 and Kuracina, further in view of Newby.
Regarding claim 18, Shaw ‘220 as modified does not teach “wherein the sealing cap is removably coupleable with the luer cap”.
Newby teaches wherein the sealing cap (22) is removably coupleable. (Page 5, paragraph 4; Page 6, lines 1-4).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Shaw ‘220 as modified to provide “wherein the sealing cap is removably coupleable” as taught by Newby, with the luer cap of Shaw. Doing so provides a construction feature facilitates the manufacturing process. (Page 6, lines 2-3).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 2/13/2026, with respect to the rejections of claims 1-21 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Abrahamson is relied upon.
Conclusion
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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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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