Notice of Pre-AIA or AIA Status0
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 06 February 2026 has been entered. Claim(s) 1, 4-14, and 17-26 remain pending in the application. Applicant’s amendments to the specification and claims have overcome each and every objection to the specification, and each and every rejection under 35 U.S.C. 102/103 previously set forth in the Office Action mailed 6 October 2025.
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, 4-5, 9, 13-14, 17-18, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy (US 5084028 A) in view of Richardson (US 5322164 A).
Regarding claim 1, Kennedy teaches a sample tube holder including an elongated body defining an interior chamber (Dispenser 10), open at one end (Fig. 1A, the bottom of the dispenser 10) and including a lid pivotally attached to the open end of the elongated body (Hinged door 16) and movable to a closed position (See closed position in Fig. 3), the lid including an aperture that extends through at least one edge of the lid (See aperture formed by groove 18 and extending through the side to connect with slots 40; Col. 1, line 60-66 and Col. 3, lines 14-19-- A groove in the base of the door allows insertion of the needle through the door into the cover aperture. Wedge shaped slots in opposite sides of the dispenser, and which are parallel to the base of the hinged door, accommodate the wings to allow complete insertion of the needle into the needle cover), the aperture being sized to receive a vascular access needle and at least a portion of a needle protector (Fig. 2B-2C and 2AA-2CC; Col. 1, line 35-37), wherein the lid closes over said vascular access needle including a sharpened end of the vascular access needle and said at least a portion of the needle protector and thereby captures the sharpened end of the vascular access needle and said at least a portion of the needle protector within the chamber defined by the elongated body when the lid is in the closed position (See Figs. 2B and 3—the hinged door is capable of closing over the needle and wings, capturing the needle within the elongated chamber of the dispenser; Col. 1, line 65-66-- complete insertion of the needle into the needle cover).
However, Kennedy fails to disclose a latch to retain the lid in the closed position.
Richardson, in the same field of endeavor of a disposal system for used needles, discloses a receptacle including a lid (Container body including closures 24 and 26), wherein the lid includes a latch to retain the lid in the closed position (Temporary closure means 40, 42, and 44 and permanent closure means 30 and 32).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Kennedy to include a latch as described by Richardson in order to predictably improve the device by providing a means of retaining the lid in a closed position to prevent accidental removal of the covers from the dispenser during transport.
Regarding claim 4, the combination of Kennedy and Richardson teaches the sample tube holder of claim 1. Kennedy additionally teaches the lid is pivotally attached to the elongated body at one side edge and the aperture extends through a side edge opposite the one side edge (Fig. 1A-1B—lid 16 is pivotally attached via hinges 20 to the elongated body 10 at one side and the aperture including groove 18 extends through a side edge opposite).
Regarding claim 5, the combination of Kennedy and Richardson teaches the sample tube holder of claim 1. Kennedy additionally teaches in which the vascular access needle and needle protector are part of a needle assembly and the aperture is configured to allow a portion of the needle assembly to extend through the aperture while capturing the vascular access needle and needle protector within the elongated body (Fig. 2B-2C and 2AA-2CC; Col. 1, line 35-37 and Col. 1, line 65-66-- complete insertion of the needle into the needle cover).
Regarding claim 9, the combination of Kennedy and Richardson teaches the sample tube holder of claim 1. Kennedy additionally teaches in which the lid is pivotally attached to the elongated body by a hinge comprising a connecting hinge portion and an active hinge portion (Hinges 20 serve as an active hinge while the part of the door 16 between the hinges serves as the connecting hinge portion, Fig. 1B, 2A).
Regarding claim 13, Kennedy teaches a method of using a sample tube holder including an elongated body (Dispenser 10), open at one end (Fig. 1A, the bottom of the dispenser 10) and including a lid pivotally attached to the open end of the elongated body (Hinged door 16) and movable to a closed position (See closed position in Fig. 3), the lid including an aperture that extends through at least one edge of the lid (See aperture formed by groove 18 and extending through the side to connect with slots 40; Col. 1, line 60-66 and Col. 3, lines 14-19-- A groove in the base of the door allows insertion of the needle through the door into the cover aperture. Wedge shaped slots in opposite sides of the dispenser, and which are parallel to the base of the hinged door, accommodate the wings to allow complete insertion of the needle into the needle cover), the aperture being sized to receive a vascular access needle and at least a portion of a needle protector (Fig. 2B-2C and 2AA-2CC; Col. 1, line 35-37), wherein the lid closes over said vascular access needle including a sharpened end of the vascular access needle and said at least a portion of the needle protector and thereby captures the sharpened end of the vascular access needle and said at least a portion of the needle protector within the chamber defined by the elongated body when the lid is in the closed position (See Figs. 2B and 3—the hinged door is capable of closing over the needle and wings, capturing the needle within the elongated chamber of the dispenser; Col. 1, line 65-66-- complete insertion of the needle into the needle cover), said method comprising inserting said vascular access needle and needle protector into the open end of the elongated body of the sample tube holder (Fig. 2B-2C and 2AA-2CC; Col. 1, line 35-37 and Col. 1, line 65-66-- complete insertion of the needle into the needle cover), closing the lid after such inserting and capturing the access needle and needle protector in the elongated body of the sample tube holder (Col. 3, line 19-24-- the needle 30 has been fully inserted into the dispenser 10 and into the needle cover 14 with the wings 31 in the slots 40 and gripped by teeth 41 and slots 26. In FIG. 2C the needle 30 is being withdrawn from dispenser 10, the hinged door 16, raised by the cover 14 as it is removed with a needle attached).
However, Kennedy fails to disclose latching the lid.
Richardson, in the same field of endeavor of a disposal system for used needles, discloses a receptacle including a lid (Container body including closures 24 and 26), wherein the lid includes a latch to retain the lid in the closed position (Temporary closure means 40, 42, and 44 and permanent closure means 30 and 32).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Kennedy to include a latch as described by Richardson in order to predictably improve the device by providing a means of retaining the lid in a closed position to prevent accidental removal of the covers from the dispenser during transport.
Regarding claim 14, Kennedy teaches a medical fluid flow system including an access needle for accessing the vascular system of a human subject (Needle 30), a needle protector for protecting the access needle from accidental stick after usage (Needle cover 14), and a sample tube holder including an elongated body defining an interior chamber (Dispenser 10), open at one end (Fig. 1A, the bottom of the dispenser 10) and including a lid pivotally attached to the open end of the elongated body (Hinged door 16) and movable to a closed position (See closed position in Fig. 3), the lid including an aperture that extends through at least one edge of the lid (See aperture formed by groove 18 and extending through the side to connect with slots 40; Col. 1, line 60-66 and Col. 3, lines 14-19-- A groove in the base of the door allows insertion of the needle through the door into the cover aperture. Wedge shaped slots in opposite sides of the dispenser, and which are parallel to the base of the hinged door, accommodate the wings to allow complete insertion of the needle into the needle cover), the aperture being sized to receive a vascular access needle and at least a portion of a needle protector (Fig. 2B-2C and 2AA-2CC; Col. 1, line 35-37), wherein the lid closes over said vascular access needle including a sharpened end of the vascular access needle and said at least a portion of the needle protector and thereby captures the sharpened end of the vascular access needle and said at least a portion of the needle protector within the chamber defined by the elongated body when the lid is in the closed position (See Figs. 2B and 3—the hinged door is capable of closing over the needle and wings, capturing the needle within the elongated chamber of the dispenser; Col. 1, line 65-66-- complete insertion of the needle into the needle cover).
However, Kennedy fails to disclose a latch to retain the lid in the closed position.
Richardson, in the same field of endeavor of a disposal system for used needles, discloses a receptacle including a lid (Container body including closures 24 and 26), wherein the lid includes a latch to retain the lid in the closed position (Temporary closure means 40, 42, and 44 and permanent closure means 30 and 32).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Kennedy to include a latch as described by Richardson in order to predictably improve the device by providing a means of retaining the lid in a closed position to prevent accidental removal of the covers from the dispenser during transport.
Regarding claim 17, the combination of Kennedy and Richardson teaches the medical fluid flow system of claim 14. Kennedy additionally teaches the lid is pivotally attached to the elongated body at one side edge and the aperture extends through a side edge opposite the one side edge (Fig. 1A-1B—lid 16 is pivotally attached via hinges 20 to the elongated body 10 at one side and the aperture including groove 18 extends through a side edge opposite).
Regarding claim 18, the combination of Kennedy and Richardson teaches the medical fluid flow system of claim 14. Kennedy additionally teaches in which the vascular access needle and needle protector are part of a needle assembly and the aperture is configured to allow a portion of the needle assembly to extend through the aperture while capturing the vascular access needle and needle protector within the elongated body (Fig. 2B-2C and 2AA-2CC; Col. 1, line 35-37 and Col. 1, line 65-66-- complete insertion of the needle into the needle cover).
Regarding claim 22, the combination of Kennedy and Richardson teaches the medical fluid flow system of claim 14. Kennedy additionally teaches in which the lid is pivotally attached to the elongated body by a hinge comprising a passive hinge portion and an active hinge portion (Hinges 20 serve as an active hinge while the part of the door 16 between the hinges serves as the passive connecting hinge portion, Fig. 1B, 2A).
Response to Arguments
Applicant’s arguments, see page 4 of applicant's remarks, filed 06 February 2026, with respect to the rejection(s) of claim(s) 1, 4-14, and 17-26 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kennedy and Richardson as described above.
Regarding the newly amended limitation of “captures the sharpened end of the vascular access needle and said at least a portion of the needle protector within the chamber defined by the elongated body”, while both Hollister (US 5993426 A—previously cited) and Woehr (US 9867951 B2—previously cited) disclose an elongated body which may be interpreted as defining an interior chamber (in each case, an inner passage through a cylinder-shaped body), the applicant’s arguments are persuasive with respect to the failure of the references to teach or fairly suggest capturing the sharpened end of the vascular access needle within the chamber defined by the elongated body, instead of or in addition to capturing said sharpened end within the lid of the device. As both Hollister and Woehr disclose devices with pivoting lids which serve as needle guards which capture the sharpened end of the vascular access needle, any attempt to modify either reference to capture said sharpened end within an interior chamber of the elongated body would be incompatible with the structure of either device.
Allowable Subject Matter
Claims 6-8, 10-12, 19-21, and 23-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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