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 .
Response to Amendment
The amendment filed March 11, 2026 has been entered. Claims 1-25 remain pending in the application. Applicant’s amendments to the abstract have overcome the objections previously set forth in the Non-Final Office Action mailed December 12, 2025.
Claim Objections
Claim 3 is objected to because of the following informalities: there is a typo regarding “the an inner peripheral portion” in line 2 as opposed to “the inner peripheral portion”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: there is a typo regarding “a plug” in line 5 as opposed to “the plug”. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: there is a typo regarding “the Luer fitting” in line 2 (two instances) as opposed to “the female Luer fitting”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the peripheral ledge" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the peripheral ledge” is the same structure as “an annular ledge” of the inner peripheral portion introduced in claim 1, line 8 or if the device comprises both an annular ledge and a separate peripheral ledge. For examination purposes, “the peripheral ledge” has been interpreted to be the same structure as “an annular ledge” of the inner peripheral portion introduced in claim 1, line 8. Claim 23 also recites the limitation “the peripheral ledge” in line 1.
Claims 23-24 are rejected for being dependent upon claim 22.
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.
Claims 1-2, 4-11, 13-17, and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Colantonio et al. (US 20120321532) in view of Jiang et al. (WO 2021026199).
Regarding claim 1, Colantonio discloses a female Luer fitting disinfection device (Figures 13-14) configured to disinfect a female Luer fitting of a medical device (noted that “a female Luer fitting of a medical device” is not positively recited or claimed. The limitation “configured to disinfect a female Luer fitting of a medical device” is considered to be a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The device shown in Figures 13-14 is capable of disinfecting a female Luer fitting of a medical device), the female Luer fitting disinfection device comprising:
a container (ampule 14) comprising a bottom surface, a side wall, and an open end (Figures 13-15);
a porous foam insert (scrubbing finger webs 55: “These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge” [0052] and compressible sponge 56) disposed within the container (Figure 13), the porous foam insert comprising a central region (central distal portion of sponge 56; Figure 13), an outer peripheral portion (scrubbing finger webs 55) that is precut to form a plurality of outer peripheral segments configured to disinfect an outer peripheral portion of the female Luer fitting (“inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52. These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge or the like to flexibly engage and scrub the exterior surfaces of the collar 52 and the probe tip 20.” [0052]; Figure 13) and an inner peripheral portion (annular portion of sponge 56 radially adjacent to scrubbing finger webs 55; Figure 13) that forms an annular ledge that is further from the open end than the outer peripheral portion and configured to disinfect a distal end of the female Luer fitting (Figure 13-14; “The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0053]);
a liquid disinfectant in the container and absorbed within the porous foam insert (“A reservoir of the sterilization fluid may also be retained in the bottom portion of the chamber 15 by compressible sponge 56 as illustrated in FIGS. 13 and 14. The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0053]); and
a sealing web (seal 21’’) covering the open end of the container (“the removable seals 21'' seal over the upwardly open mouths of the respective ampules 14” [0055]; Figure 15).
Colantonio fails to explicitly disclose a plug positioned within the central region, the plug sized and shaped to fit within a lumen of the female Luer; the plug configured to prevent ingress of the liquid disinfectant absorbed within the porous foam insert during disinfecting of the female Luer fitting.
Jiang teaches a female Luer fitting disinfection device (cap 100) configured to disinfect a female Luer fitting (medical connector 450) of a medical device (Figure 17), the female Luer fitting disinfection device comprising: a container (housing 102); a porous foam insert (disinfection sponge 200) disposed within the container (Figure 11), the porous foam insert comprising a central region (hollow 206; Figure 9); a plug (insert 150) positioned within the central region (Figure 11; “insert 150 resides in a hollow 206 defined by the disinfection sponge 200.” [0105]), the plug sized and shaped to fit within a lumen (lumen 452) of the female Luer fitting (Figure 17; “When the insert 150 engages with the open lumen 452, a complementary inner wall, e.g. Luer wall, applies radial pressure on the insert 150 to make the snap fit tighter by bending prongs on the insert inward towards the central axis, and preventing insert from moving along central axis even when subject to a force along the central axis.” [0123]); a liquid disinfectant in the container and absorbed within the porous foam insert (“the disinfection sponge comprises a disinfectant” [0046]; “the disinfectant is a fluid” [0100]), the plug (insert 150) configured to prevent ingress of the liquid disinfectant absorbed within the porous foam insert during disinfecting of the female Luer fitting (“The insert 150 inhibits 21 and/or prevents disinfectant from ingressing into the lumen 452” [0123]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include a plug positioned within the central region of the porous foam insert, the plug sized and shaped to fit within a lumen of the female Luer and configured to prevent ingress of the liquid disinfectant absorbed within the porous foam insert during disinfecting of the female Luer fitting based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]) and adapt the female Luer fitting disinfection device to be a universal disinfecting cap to streamline disinfecting processes (Jiang [0007]).
Regarding claim 2, modified Colantonio discloses the female Luer fitting disinfection device of claim 1, wherein the plurality of outer peripheral segments are configured to move individually and function similar to bristles of a scrub brush to clean the outer peripheral portion of the female Luer fitting (“The chamber 15 includes an annular array of inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52. These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge or the like to flexibly engage and scrub the exterior surfaces of the collar 52 and the probe tip 20.” [0052]).
Regarding claim 4, modified Colantonio discloses the female Luer fitting disinfection device of claim 1, wherein the porous foam insert is compressible upon application of a distally directed force with the female Luer fitting (“The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0053]).
Regarding claim 5, modified Colantonio discloses the female Luer fitting disinfection device of claim 4, wherein the plurality of outer peripheral segments are configured to contact and disinfect lugs or threads on an outer peripheral surface of the female Luer fitting (“The chamber 15 includes an annular array of inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52. These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge or the like to flexibly engage and scrub the exterior surfaces of the collar 52 and the probe tip 20.” [0052], noted that “lugs or threads on an outer peripheral surface of the female Luer fitting” are not positively recited. The limitation “the plurality of outer peripheral segments are configured to contact and disinfect lugs or threads on an outer peripheral surface of the female Luer fitting” is a recitation of intended use and the disclosed structure of the outer peripheral segments is capable of contacting and disinfecting lugs or threads on an outer peripheral surface of a female Luer fitting).
Regarding 6, modified Colantonio discloses the female Luer fitting disinfection device of claim 1.
Modified Colantonio fails to explicitly disclose the plug is removably attached to the container.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); and a plug (insert 150) removably attached to the container (Figure 11; “The insert 150 engages with the elongate member 130 along the inside surface 158 of the top edge 151. In one or more embodiments, the insert 150 snap-fits onto the elongate member 130” [0105]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include a plug is removably attached to the container based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]) and allow for simple assembly of the female Luer fitting disinfection device (Jiang [0105]).
Regarding claim 7, modified Colantonio discloses the female Luer fitting disinfection device of claim 6.
Modified Colantonio fails to explcitily disclose the plug is removably attached to the container via a snap joint on a protrusion extending from the bottom surface of the container.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); and a plug (insert 150) removably attached to the container via a snap joint on a protrusion (elongate member 130) extending from the bottom surface of the container (Figure 11; “The insert 150 engages with the elongate member 130 along the inside surface 158 of the top edge 151. In one or more embodiments, the insert 150 snap-fits onto the elongate member 130” [0105]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include a plug removably attached to the container via a snap joint on a protrusion extending from the bottom surface of the container based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]) and allow for simple assembly of the female Luer fitting disinfection device (Jiang [0105]).
Regarding claim 8, modified Colantonio discloses the female Luer fitting disinfection device of claim 6.
Modified Colantonio fails to explcitily disclose the plug is removably attached to a protrusion extending from the bottom surface of the container via a friction fitting.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); and a plug (insert 150) extending from the bottom surface of the container via a friction fitting (Figure 11; “The insert 150 engages with the elongate member 130 along the inside surface 158 of the top edge 151. In one or more embodiments, the insert 150 snap-fits onto the elongate member 130” [0104], wherein the snap-fitting includes a friction fitting).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include a plug removably attached to a protrusion extending from the bottom surface of the container via a friction fitting based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]) and allow for simple assembly of the female Luer fitting disinfection device (Jiang [0105]).
Regarding claim 9, modified Colantonio discloses the female Luer fitting disinfection device of claim 1.
Modified Colantonio fails to explcitily disclose the plug is interference fit in the female Luer fitting.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); and a plug (insert 150) that is interference fit in the female Luer fitting (Figure 11; “The insert 150… comprises…A plurality of slits 164 exists radially around the top edge 151, which define multiple prongs 162 around top edge 151 of the insert 150…The slits 164 provide flexibility to each prong 162, allowing the insert 150 to slide along an elongate member (e.g., item 130 of FIGS. 2-3) when a force along the central axis (e.g., “a” of FIG. 2) is applied, such as when a needless connector or IV tubing end is attached to the cap.” [0108]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include a plug interference fit in the female Luer fitting based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]) and adapt the female Luer fitting disinfection device to be a universal disinfecting cap to streamline disinfecting processes (Jiang [0007]).
Regarding claim 10, modified Colantonio discloses the female Luer fitting disinfection device of claim 1.
Modified Colantonio fails to explicitly disclose the container and foam insert are rotatable relative to the plug.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); and a plug (insert 150); wherein the container and foam insert are rotatable relative to the plug (Figures 3-7 and 11 showing that the insert 150 can freely rotate about elongate member 130 and the housing 102 and sponge 200 are therefore rotatable relative to the insert 150).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include a plug, wherein the container and foam insert are rotatable relative to the plug based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]) and adapt the female Luer fitting disinfection device to be a universal disinfecting cap to streamline disinfecting processes (Jiang [0007]).
Regarding claim 11, modified Colantonio discloses the female Luer fitting disinfection device of claim 1.
Modified Colantonio fails to explcitily disclose the liquid disinfectant is in contact with the plug and disinfects the lumen of the female Luer fitting.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); a plug (insert 150); and a liquid disinfectant in contact with the plug (“the disinfection sponge comprises a disinfectant, an antimicrobial agent, or combinations thereof.” [0045]) and disinfects the lumen of the female Luer fitting (“The lumen edge 454 pushes the sponge 200 toward the top wall 104 at a closed end of the housing 102, allowing disinfectant to be dispensed onto the lumen edge 454.” [0123]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the female Luer fitting disinfection device of Colantonio to include the liquid disinfectant is in contact with the plug and disinfects the lumen of the female Luer fitting based on the teachings of Jiang to disinfect the edge of the lumen of the female Luer fitting while continuing to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008], [0123]) and adapt the female Luer fitting disinfection device to be a universal disinfecting cap to streamline disinfecting processes (Jiang [0007]).
Regarding claim 13, modified Colantonio discloses the female Luer fitting disinfection device of claim 1, wherein the liquid disinfectant is alcohol.
Modified Colantonio fails to explicitly disclose the liquid disinfectant is selected from the group consisting of isopropyl alcohol, chlorhexidine gluconate in isopropyl alcohol, and chlorhexidine acetate in isopropyl alcohol.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); a plug (insert 150); and a liquid disinfectant (“the disinfection sponge comprises a disinfectant” [0046]; “the disinfectant is a fluid” [0100]), wherein the liquid disinfectant is selected from the group consisting of isopropyl alcohol, chlorhexidine gluconate in isopropyl alcohol, and chlorhexidine acetate in isopropyl alcohol (“the disinfectant or the antimicrobial agent is selected from the group consisting essentially of: isopropyl alcohol” [0047]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the liquid disinfectant of the female Luer fitting disinfection device of Colantonio to be selected from the group consisting of isopropyl alcohol, chlorhexidine gluconate in isopropyl alcohol, and chlorhexidine acetate in isopropyl alcohol based on the teachings of Jiang to disinfect a female Luer fitting connected to the female Luer fitting disinfection device (Jiang [0100]).
Regarding claim 14, modified Colantonio discloses the female Luer fitting disinfection device of claim 1, wherein the sealing web is removable (“the removable seals 21''” [0055]).
Regarding claim 15, modified Colantonio discloses the female Luer fitting disinfection device of claim 13.
Modified Colantonio fails to explcitily disclose the sealing web comprises at least one of aluminum and a multi-layer polymer.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); a plug (insert 150); a liquid disinfectant (“the disinfection sponge comprises a disinfectant, an antimicrobial agent, or combinations thereof.” [0046]; “the disinfectant is a fluid” [0100]); and a sealing web covering the open end of the container (“a peel seal can be provided to seal the opening 110 prior to use of cap 100” [0114]), wherein the sealing web comprises at least one of aluminum and a multi-layer polymer (“the peelable seal comprises an aluminum or multi-layer polymer film peel back top.” [0114]).
Before the effective filing date of hte claimed invention, it would have been obvious to ne having ordinary skill in the art to modify the sealing web of the female Luer fitting disinfection device of Colantonio to comprise at least one of aluminum and a multi-layer polymer based on the teachings of Jiang to seal the liquid disinfectant within the container prior to use (Jiang [0114]).
Regarding claim 16, modified Colantonio discloses the female Luer fitting disinfection device of claim 13.
Modified Colantonio fails to explcitily disclose the sealing web is heat sealed or induction sealed to the container.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); a plug (insert 150); a liquid disinfectant (“the disinfection sponge comprises a disinfectant, an antimicrobial agent, or combinations thereof.” [0046]; “the disinfectant is a fluid” [0100]); and a sealing web covering the open end of the container (“a peel seal can be provided to seal the opening 110 prior to use of cap 100” [0114]), wherein the sealing web is heat sealed or induction sealed to the container (“the peelable seal is heat-sealed or induction sealed to the open end of the cap.” [0114]).
Before the effective filing date of hte claimed invention, it would have been obvious to ne having ordinary skill in the art to modify the sealing web of the female Luer fitting disinfection device of Colantonio to be heat sealed or induction sealed to the container based on the teachings of Jiang to seal the liquid disinfectant within the container prior to use (Jiang [0114]).
Regarding claim 17, modified Colantonio discloses the female Luer fitting disinfection device of claim 1.
Modified Colantonio fails to explcitily disclose the container comprises a thermoplastic polymer.
Jiang teaches a female Luer fitting disinfection device (cap 100) comprising: a container (housing 102); a porous foam insert (disinfection sponge 200); a plug (insert 150); a liquid disinfectant ([0046]; [0100]); and a sealing web covering the open end of the container (“a peel seal can be provided to seal the opening 110 prior to use of cap 100” [0114]), wherein the container comprises a thermoplastic polymer (“The caps herein (e.g., 100, 300, 600) can be made from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices.” [0136], wherein the listed plastic materials are thermoplastic polymers).
Before the effective filing date of hte claimed invention, it would have been obvious to ne having ordinary skill in the art to modify the container of the female Luer fitting disinfection device of Colantonio to comprise a thermoplastic polymer based on the teachings of Jiang because thermoplastic polymers are both moldable and compatible for use in medical devices (Jiang [0136]).
Regarding claim 19, modified Colantonio discloses the female Luer fitting disinfection device of claim 1, wherein the plug comprises an elastomer (“These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge” [0052]).
Regarding claim 20, modified Colantonio discloses a method of disinfecting a Luer fitting (“the probe tip 20 of male medical line connector 11 is not only sterilized when docked, but in addition the receded concentric connection collar 52 also has its exposed end portions 53 and exterior portions 54 engaged with the sterilization fluid contained within chamber 15 of ampule 14. Accordingly, all of the exposed end surfaces of the tubular tip 20 and the connection collar 52 are fully treated with sterilization fluid and sterilized during the docking procedure.” [0051]; Figures 13-14), the method comprising: inserting the Luer fitting (male medical line connector 11 having connection collar 52) having a lumen (Figure 13, lumen within probe tip 20) into the device according to claim 1 (Figures 13-14); and pressing the Luer fitting against the porous foam insert and rotating the container with respect to the Luer fitting (“The chamber 15 includes an annular array of inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52…A reservoir of the sterilization fluid may also be retained in the bottom portion of the chamber 15 by compressible sponge 56 as illustrated in FIGS. 13 and 14. The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0052-0053]).
Modified Colantonio fails to explicitly teach the method for disinfecting a female Luer fitting, the method comprising : inserting the female Luer fitting into the device; sealing the lumen with a plug located in the container to prevent fluid ingress into the lumen; and pressing the female Luer fitting against the porous foam insert and rotating the container with respect to the female Luer fitting.
Jiang discloses a method of disinfecting a female Luer fitting (medical connector 450; “The connector 450 is a female medical connector with an open female Luer port” [0123]; “a method of disinfecting a medical connector" [0053]), the method comprising: inserting the female Luer fitting having a lumen (open lumen 452) into a female Luer fitting disinfection device (cap 100; Figures 11 and 17; “The male threaded fitting 458 of the connector 450 engages with the inner threads 122 of the inner surface of the protrusion 114.” [0123]); sealing the lumen with a plug (insert 150) located in the container to prevent fluid ingress into the lumen (“When the insert 150 engages with the open lumen 452, a complementary inner wall, e.g. Luer wall, applies radial pressure on the insert 150 to make the snap fit tighter by bending prongs on the insert inward towards the central axis, and preventing insert from moving along central axis even when subject to a force along the central axis…The insert 150 inhibits 21 and/or prevents disinfectant from ingressing into the lumen 452.” [0123]; Figure 17); and pressing the female Luer fitting against the porous foam insert (“The lumen edge 454 pushes the sponge 200 toward the top wall 104 at a closed end of the housing 102, allowing disinfectant to be dispensed onto the lumen edge 454.” [0123]) and rotating the container with respect to the female Luer fitting (“Upon mounting exemplary caps (100, 300, 600) onto female Luer connectors, the female Luer connectors is inserted into the second cavity and screwed onto the inner threads of the exemplary caps.” [0142], wherein the female luer connector screwing onto the inner threads would include rotating the container with respect to the female Luer fitting).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Colantonio to include the method is for disinfecting a female Luer fitting, the method comprising inserting a female Luer fitting into the device, sealing the lumen with a plug located in the container, pressing the female Luer fitting against the porous foam insert, and rotating the container with respect to the female Luer fitting based on the teachings of Jiang to adapt the method and female Luer fitting disinfection device to be a universal method and disinfecting cap to streamline disinfecting processes (Jiang [0007]) and to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]).
Regarding claim 21, modified Colantonio discloses the method of claim 20, further comprising cleaning the distal end of the Luer fitting and the outer peripheral portion of the Luer fitting (“The chamber 15 includes an annular array of inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52. These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge or the like to flexibly engage and scrub the exterior surfaces of the collar 52 and the probe tip 20.” [0052]; “The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0053]; Figure 14).
Regarding claim 22, modified Colantonio discloses the method of claim 21, wherein the method further comprises pressing the female Luer fitting (as provided by Jiang) against the peripheral ledge ([annular ledge – see rejection under 35 USC 112 above], Figure 14; “The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0053]).
Regarding claim 23, modified Colantonio discloses the method of claim 22, wherein the peripheral ledge ([annular ledge – see rejection under 35 USC 112 above])disinfects a distal end of the female Luer fitting (Figure 14; “the receded concentric connection collar 52 also has its exposed end portions 53 and exterior portions 54 engaged with the sterilization fluid contained within chamber 15 of ampule 14” [0051]; “The sponge 56 accordingly absorbs the sterilization fluid and expels the fluid upon compression caused by insertion of the medical male line connector 11.” [0053], female Luer fitting as provided by Jiang).
Regarding claim 24, modified Colantonio discloses the method of claim 23, wherein the plurality of outer peripheral segments (scrubbing finger webs 55) disinfect an outer peripheral surface (outer surface of collar 52, for example) of the of the female Luer fitting (“the receded concentric connection collar 52 also has its exposed end portions 53 and exterior portions 54 engaged with the sterilization fluid contained within chamber 15 of ampule 14. Accordingly, all of the exposed end surfaces of the tubular tip 20 and the connection collar 52 are fully treated with sterilization fluid and sterilized during the docking procedure. The chamber 15 includes an annular array of inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52.” [0051-0052]; female Luer fitting as provided by Jiang).
Regarding claim 25, modified Colantonio discloses the method of claim 20.
Modified Colantonio fails to explcitily discloses the plug remains stationary during rotation of the container while the container and the porous foam insert rotates with respect to the female Luer fitting.
Jiang discloses a method of disinfecting a female Luer fitting (medical connector 450; “a method of disinfecting a medical connector" [0053]), the method comprising: inserting the female Luer fitting into a female Luer fitting disinfection device (cap 100; Figures 11 and 17); sealing the lumen with a plug (insert 150; Figure 17); and pressing the female Luer fitting against the porous foam insert (“The lumen edge 454 pushes the sponge 200 toward the top wall 104 at a closed end of the housing 102, allowing disinfectant to be dispensed onto the lumen edge 454.” [0123]) and rotating the container with respect to the female Luer fitting, wherein the plug remains stationary during rotation of the container while the container and the porous foam insert rotates with respect to the female Luer fitting (“Upon mounting exemplary caps (100, 300, 600) onto female Luer connectors, the female Luer connectors is inserted into the second cavity and screwed onto the inner threads of the exemplary caps.” [0142]; “When the insert 150 engages with the open lumen 452, a complementary inner wall, e.g. Luer wall, applies radial pressure on the insert 150 to make the snap fit tighter by bending prongs on the insert inward towards the central axis, and preventing insert from moving along central axis even when subject to a force along the central axis” [0123] wherein the female luer connector screwing onto the inner threads would include rotating the container and foam insert with respect to the female Luer fitting, and [0123] discloses that the insert 150 is held axially stationary).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Colantonio to include the plug remains stationary during rotation of the container while the container and the porous foam insert rotates with respect to the female Luer fitting based on the teachings of Jiang to minimize ingress of the disinfectant into the female Luer fitting to a non-toxic level in order to maintain patient safety (Jiang [0008]).
Claims 3, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Colantonio et al. (US 20120321532) in view of Jiang et al. (WO 2021026199) as applied in claims 1 and 2 above, and further in view of Kerr et al. (US 20140366914).
Regarding claims 3 and 12, modified Colantonio discloses (Currently Amended) The female Luer fitting disinfection device of claim 2.
Modified Colantonio fails to explcitily disclose the inner peripheral portion comprises a plurality of inner peripheral segments, as required by claim 3; and wherein the inner peripheral segments are configured to move individually and function similar to function as bristles of a scrub brush to clean the distal end of the Luer fitting, as required by claim 12.
Kerr discloses a female Luer fitting disinfection device (scrub brush 115) comprising a container (holder 114) and a porous foam insert (insert 110) having an inner peripheral portion comprising a plurality of inner peripheral segments (fingers 112) configured to move individually and function similar to function as bristles of a scrub brush to clean the distal end of the Luer fitting (“the fingers 112 of the insert 110 directly under the surfaces of the inserted portion of the catheter 117 are depressed into the holder 114, the fingers located outside the periphery of the catheter remain upright and lay against the outer peripheral surface of the catheter portion…The separate reactions of the fingers 112 are facilitated by the fingers 112 being formed in a digitated manner to be separated from each other” [0107], see also [0108]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the inner peripheral portion of the porous foam of Colantonio to comprise a plurality of inner peripheral segments configured to move individually and function similar to function as bristles of a scrub brush to clean the distal end of the Luer fitting based on the teachings of Kerr to ensure the inner peripheral portion is able to effectively and efficiently disinfect and remove biofilms from the distal end of the female Luer fitting (Kerr [0108]).
Regarding claim 18, modified Colantonio discloses the female Luer fitting disinfection device of claim 1.
Colantonio fails to explicitly disclose the porous foam insert comprises polyurethane.
Kerr discloses a female Luer fitting disinfection device (brush 20) comprising a container (housing 21) and porous foam insert (insert 22) comprising polyurethane (“The insert 22 is made of a semi-closed cell, hydrophilic polyurethane medical grade foam” [0074]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the porous foam insert of Colantonio to comprise polyurethane based on the teachings of Kerr to ensure that the porous foam insert is able to absorb the necessary volume of liquid disinfectant without leaking (Kerr [0074]).
Response to Arguments
Applicant’s arguments with respect to claims 1-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783
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