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 .
Election/Restrictions
Applicant’s election without traverse of Species A1 and Species A2 in the reply filed on March 20, 2026 is acknowledged. Claims 1-3, 6 and 9-20 are elected for examination.
Specification
The use of the term VACUTAINER, which is a trade name or a mark used in commerce, has been noted in this application in [0027] and [0035]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harding (US 20040199126 A1).
With respect to claim 19, Harding discloses a fluid shield assembly for a male luer connector (see paragraph 0074: needless luer access connector having an inlet #11 top portion #12 designed to be connected to a standard male luer taper configuration of another medical device and an outlet #17 bottom portion #16), the fluid shield assembly comprising:
an enclosure configured to couple to an end of the male luer connector (see paragraph 0074: housing #10 that has top portion #12 and bottom portion #16 that includes luer threads); and
a split septum coupled to an end of the enclosure (see paragraph 0076-0077: a septum #20 is located in top portion #12 of housing #10 where a slit #25 is formed in the septum #20 that extends longitudinally), the split septum comprising a flexible material with a centrally disposed slit (see paragraph 0076-0077: a septum #20 is located in top portion #12 of housing #10 where a slit #25 is formed in the septum #20 that extends longitudinally where typically materials such as silicone or polyisoprene could be used to form septum #20),
wherein the fluid shield assembly is configured to provide connection and disconnection of a female connector to the male luer connector through the slit of the split septum (see paragraph 0016, 0074: needless luer access connector is designed and configured so that the inlet and top portion of needless luer connector can be connected to a standard male luer taper configuration of another medical device where the septum is located in top portion of housing having a female luer configuration such that it connects to a male luer configuration), and to contain fluid within the enclosure and split septum upon disconnection and withdrawal of the female connector from the male luer connector (see paragraph 0017: when male luer taper is fully inserted into the septum, the slit is forced open along the entire length of the septum so that the septum allows fluid to flow through connector and when the male luer taper is removed the slit closes which contains the fluid within the enclosure of the housing).
With respect to claim 20, all limitations of claim 19 apply in which Harding further discloses wherein the enclosure of the fluid shield assembly comprises an internal engagement rib configured to couple with a groove on an outer surface of the male luer connector (see paragraph 0080:a rib #51 can be formed along medical portion #22 and adapted to fit in groove #50).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, and 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20220110562 A1; cited by applicant) in view of Harding (US 20040199126 A1).
With respect to claim 1, Ma discloses a flow restriction device (see paragraph 0024-0025 and Fig. 1A-1B: blood collection device #10 includes a flow restrictor #24), comprising:
a proximal housing configured to couple to a fluid collection device (see paragraph 0026 and Fig. 1A-1B: a flow restrictor #24 may include a second luer adapter #30 coupled to first luer adapter #30 where the proximal end #16 of the flow restrictor #24 is interpreted to be a proximal housing which couples to syringe #12 where the syringe #12 is interpreted to be a fluid collection device);
a distal housing configured to couple to a catheter assembly (see paragraph 0027 and Fig. 1A-1B: the distal end #26 of flow restrictor #24 may include a third luer adapter #34 where the distal end #26 where the third luer adapter #34 is interpreted to be a distal housing where the distal end #26 of flow restrictor is configured to be coupled to a catheter assembly);
an intermediate housing interposed between the proximal housing and the distal housing (see paragraph 0028 and Fig. 1A-1B: the body of the flow restrictor #24 between the distal end #26 and proximal end #16 is interpreted to be an intermediate housing may include a fluid pathway #36 extending throughout which is interpreted to be an intermediate housing);
an internal fluid channel extending transversely through the proximal, intermediate and distal housings (see paragraph 0028 and Fig. 1A-1B: the length of the flow restrictor #24 which includes the entirety of the flow restrictor may include a fluid pathway #36 extending throughout longitudinally which is interpreted to be an internal fluid channel);
Ma does not disclose a fluid shield assembly comprising: an enclosure coupled to an end of the distal housing; and a split septum coupled to an end of the enclosure, the split septum comprising a flexible material with a centrally disposed slit, wherein the fluid shield assembly is configured to allow connection and disconnection of a female connector to a male connector of the distal housing through the slit of the split septum, and to contain fluid within the enclosure and split septum upon disconnection and withdrawal of the female connector from the male connector.
Harding teaches a fluid shield assembly (see paragraph 0074: needless luer access connector having an inlet #11 top portion #12 designed to be connected to a standard male luer taper configuration of another medical device and an outlet #17 bottom portion #16 ) comprising: an enclosure (see paragraph 0074: housing #10 that has top portion #12 and bottom portion #16); and a split septum coupled to an end of the enclosure (see paragraph 0076-0077: a septum #20 is located in top portion #12 of housing #10 where a slit #25 is formed in the septum #20 that extends longitudinally) the split septum comprising a flexible material with a centrally disposed slit (see paragraph 0076-0077: a septum #20 is located in top portion #12 of housing #10 where a slit #25 is formed in the septum #20 that extends longitudinally where typically materials such as silicone or polyisoprene could be used to form septum #20), wherein the fluid shield assembly is configured to allow connection and disconnection of a female connector to a male connector through the slit of the split septum (see paragraph 0016, 0074: needless luer access connector is designed and configured so that the inlet and top portion of needless luer connector can be connected to a standard male luer taper configuration of another medical device where the septum is located in top portion of housing having a female luer configuration such that it connects to a male luer configuration), and to contain fluid within the enclosure and split septum upon disconnection and withdrawal of the female connector from the male connector (see paragraph 0017: when male luer taper is fully inserted into the septum, the slit is forced open along the entire length of the septum so that the septum allows fluid to flow through connector and when the male luer taper is removed the slit closes which contains the fluid within the enclosure of the housing).
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 Ma with the teachings of Harding as it is standard clinical practice to attach a needless connector to the distal end of an flow resistor before connecting to a catheter assembly (Harding: see [0009]; [0074]).
With respect to claim 2, all limitations of claim 1 apply in which the combination of Ma and Harding further teaches wherein the enclosure of the fluid shield assembly comprises an internal engagement rib configured to couple with a groove on the distal housing (Harding: see paragraph 0080:a rib #51 can be formed along medical portion #22 and adapted to fit in groove #50).
With respect to claim 3, all limitations of claim 2 apply in which Harding further teaches wherein the engagement rib is affixed to the groove by one of an adhesive and a solvent (see paragraph 0078: standard bonding technique such as chemical adhesive bonds).
With respect to claim 6, all limitations of claim 1 apply in which Harding further teaches wherein the split septum is affixed to the enclosure by one of an adhesive and a solvent (see paragraph 0078: standard bonding technique such as chemical adhesive bonds septum #20 to housing #10).
With respect to claim 9, all limitations of claim 1 apply in which Ma further discloses wherein the flow restriction device is configured to flow blood from the proximal housing to the distal housing and into the fluid collection device, and the fluid collection device comprises a blood collection device (see paragraph 0027: flow restrictor #24 may be configured to couple to catheter assembly which may be inserted into vasculature of patient which blood may be withdrawn via a sliding plunder #18 into a tube #20 of syringe #12 which makes the syringe #12 a blood collection device).
With respect to claim 10, all limitations of claim 1 apply in which the combination of Ma and Harding further teaches wherein the female connector is a needle-free connector of the catheter assembly (Ma: see paragraph 0038, catheter assembly may include any suitable catheter assembly; and see Harding: needle free connector).
With respect to claim 11, all limitations of claim 1 apply in which Ma further discloses wherein the proximal housing, the intermediate housing and the distal housing comprise an integral connector assembly having a female connector at the proximal housing and the male connector at the distal housing (see paragraph 0026-0027: flow restrictor #24 may be monolithically formed as a single unit with the distal end including a third luer adapter #34 and proximal end including a second luer adapter #32).
With respect to claim 12, all limitations of claim 1 apply in which Ma further discloses wherein the intermediate housing comprises an intravenous tube connecting a female connector at the proximal housing and the male connector at the distal housing (see paragraph 0036-0039: catheter assembly #42 may include an extension tube #52 with the blood collection device being coupled to the proximal end of extension tube where the extension tube provides a fluid conduit between catheter adapter and luer adapter).
With respect to claim 13, Ma discloses a blood collection system (see paragraph Fig. 3: blood collection system), comprising:
a blood collection device (see Fig. 2A-2B, 3 and see paragraph 0033: blood collection device #10);
a catheter assembly (see Fig. 3 and see paragraph 0036: catheter assembly #46); and
a flow restriction device fluidly coupled to the blood collection device (see paragraph 0033: blood collection device #10 may include a flow restrictor), the flow restriction device comprising:
a proximal housing coupled to a male connector of the blood collection device (see paragraph 0026 and Fig. 1A-1B: a flow restrictor #24 may include a second luer adapter #30 coupled to first luer adapter #30 where the proximal end #16 of the flow restrictor #24 is interpreted to be a proximal housing which couples to syringe #12 where the syringe #12 is interpreted to be a fluid collection device; first luer adapter may include a male luer adapter and second luer adapter may include a female luer adapter where if second luer adapter is an female luer adapter on the proximal end of flow restrictor then it connects to a male connector of the syringe);
a distal housing comprising a male luer connector configured to couple to a female connector of the catheter assembly (see paragraph 0027 and Fig. 1A-1B: the distal end #26 of flow restrictor #24 may include a third luer adapter #34 where the distal end #26 where the third luer adapter #34 male includes a male luer adapter is interpreted to be a distal housing where the distal end #26 of flow restrictor is configured to be coupled to a catheter assembly);
an intermediate housing interposed between the proximal housing and the distal housing (see paragraph 0028 and Fig. 1A-1B: the body of the flow restrictor #24 between the distal end #26 and proximal end #16 is interpreted to be an intermediate housing may include a fluid pathway #36 extending throughout which is interpreted to be an intermediate housing);
an internal fluid channel extending transversely through the proximal, intermediate and distal housings (see paragraph 0028 and Fig. 1A-1B: the length of the flow restrictor #24 which includes the entirety of the flow restrictor may include a fluid pathway #36 extending throughout longitudinally which is interpreted to be an internal fluid channel).
Ma does not disclose a fluid shield assembly comprising: a luer enclosure coupled to an end of the distal housing; and a split septum coupled to an end of the enclosure, the split septum comprising a flexible material with a centrally disposed slit, the split septum and the luer enclosure enclosing the male luer connector and an end portion of the distal housing, wherein the fluid shield assembly provides for connection and disconnection of the female connector of the catheter assembly to the male luer connector of the distal housing through the slit of the split septum, and to contain excess blood within the enclosure and split septum upon disconnection and withdrawal of the female connector from the male luer connector.
Harding teaches a fluid shield assembly (see paragraph 0074: needless luer access connector having an inlet #11 top portion #12 designed to be connected to a standard male luer taper configuration of another medical device and an outlet #17 bottom portion #16 ) comprising: an luer enclosure (see paragraph 0074: housing #10 that has top portion #12 and bottom portion #16 that includes luer threads); and a split septum coupled to an end of the enclosure (see paragraph 0076-0077: a septum #20 is located in top portion #12 of housing #10 where a slit #25 is formed in the septum #20 that extends longitudinally) the split septum comprising a flexible material with a centrally disposed slit (see paragraph 0076-0077: a septum #20 is located in top portion #12 of housing #10 where a slit #25 is formed in the septum #20 that extends longitudinally where typically materials such as silicone or polyisoprene could be used to form septum #20), the split septum and the luer enclosure enclosing the male luer connector (see paragraph 0074-0077: needless luer access connector having an inlet #11 top portion #12 that has a septum #20 designed to be connected to a standard male luer taper configuration of another medical device) wherein the fluid shield assembly provides for connection and disconnection of the female connector to the male luer connector through the slit of the split septum, (see paragraph 0016, 0074: needless luer access connector is designed and configured so that the inlet and top portion of needless luer connector can be connected to a standard male luer taper configuration of another medical device where the septum is located in top portion of housing having a female luer configuration such that it connects to a male luer configuration), and to contain excess blood within the enclosure and split septum upon disconnection and withdrawal of the female connector from the male luer connector (see paragraph 0017: when male luer taper is fully inserted into the septum, the slit is forced open along the entire length of the septum so that the septum allows fluid to flow through connector and when the male luer taper is removed the slit closes which contains the fluid within the enclosure of the housing).
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 Ma with the teachings of Harding as it is standard clinical practice to attach a needless connector to the distal end of an flow resistor before connecting to a catheter assembly (Harding: see [0009]; [0074]).
With respect to claim 14, all limitations of claim 13 apply in which the combination of Ma and Harding further teaches wherein the enclosure of the fluid shield assembly comprises an internal engagement rib configured to couple with a groove on the distal housing (Harding: see paragraph 0080:a rib #51 can be formed along medical portion #22 and adapted to fit in groove #50).
With respect to claim 15, all limitations of claim 14 apply in which Harding further teaches wherein the engagement rib is affixed to the groove by one of an adhesive (see paragraph 0078: standard bonding technique such as chemical adhesive bonds), a solvent, a weld and an over mold.
With respect to claim 16, all limitations of claim 13 apply in which Harding further teaches wherein the split septum is affixed to the enclosure by one of an adhesive (see paragraph 0078: standard bonding technique such as chemical adhesive bonds septum #20 to housing #10), a solvent, a weld and an over mold.
With respect to claim 17, all limitations of claim 13 apply in which Ma further discloses wherein the proximal housing, the intermediate housing and the distal housing comprise an integral connector assembly having a female connector at the proximal housing and the male luer connector at the distal housing (see paragraph 0026-0027: flow restrictor #24 may be monolithically formed as a single unit with the distal end including a third luer adapter #34 and proximal end including a second luer adapter #32).
With respect to claim 18, all limitations of claim 13 apply in which Ma further discloses wherein the intermediate housing comprises an intravenous tube connecting a female connector at the proximal housing and the male luer connector at the distal housing (see paragraph 0036-0039: catheter assembly #42 may include an extension tube #52 with the blood collection device being coupled to the proximal end of extension tube where the extension tube provides a fluid conduit between catheter adapter and luer adapter).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI N PATEL whose telephone number is (571)272-2379. The examiner can normally be reached Mondays to Fridays 9AM-5PM.
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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