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 .
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.
Claim 9 is 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 9 recites in lines 1-2 “…wherein upon closing of the cover to form an airtight seal, a confirmatory feedback signal is audibly communicated to a user…”. Claim 9 is an apparatus claim, and it is not clear if claim 9 recites a method step for using the apparatus requiring the method step of closing. MPEP 2173.05(p)(II) recites that a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. For purposes of examination, this is interpreted as “…in the closed configuration the cover is configured to form an airtight seal, and the cap assembly is further configured to communicate audibly to a user a confirmatory feedback signal when the cap assembly is moved from the open position to the closed position…”.
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 1-2, 4, 8, 11-12 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al. (Davis) US 2009/0175759 A1.
Regarding claim 1, Davis discloses a cap assembly (device 30, P0036-0038 and shown in Figs. 4-6) capable of disinfectingly enclosing (needleless hub disinfection device) a Luer-type fitting (adaptable to all types of fittings, with both male and female luer ends, P0054) of an injection port of an intravenous administration set (medical implement 16 preferably comprising a needleless hub or injection port, P0029) or capable of enclosing a hypodermic needle-puncturable stopper on a single-dose stoppered vial containing sterile drug or diluent, said cap assembly comprising: a base (collar 32, P0037) having a first or bottom end configured to couple to the injection port or the stoppered vial and a second or top end configured to receive cover (see annotated Fig. 4 below), a cover (cowl 34, P0037) having an outer surface and an inner surface, said cover being moveable between an open position (Fig. 5) and a closed position (Figs. 4 and 6), and a disinfecting means disposed on the inner surface of the cover (disinfectant pad 38, P0037), wherein the disinfectant means is selected from an absorbent pad or adsorbent pad (see attached definition of pad of absorbent material used as a protective covering) retaining a disinfectant (disinfectant pad 38, P0037), and an ultraviolet (UV)-light source, wherein said base and cover are hingedly or pivotally (cowl 34 is pivotally mounted on the collar 32, P0037) affixed to one another wherein said hinge or pivot is spring-loaded (torsion spring 40, P0038) such that the cover is biased in the closed position to form a self-closing cover (torsion spring 40 seeks to urge the cowl 34 to the rest position shown in Figs. 4 and 6, P0038).
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Regarding claim 2, Davis discloses the cap assembly of claim 1 wherein the cap assembly is separate from and connectable to the Luer-type fitting provided on the injection port of an intravenous administration set (the body includes an aperture shaped to accommodate the needless hub or injection port, P0007).
Regarding claim 4, Davis discloses the cap assembly of claim 1 wherein the cap assembly is formed integrally with (this is interpreted as a product by process claim limitation, see MPEP 2113(I), and here, the product of the claim is the same as the product of Davis) and part of the injection port of an intravenous administration set (Figs. 4-6).
Regarding claim 8, Davis discloses the cap assembly of claim 1, wherein the cap has a domed outer surface (Figs. 4-6 showing a domed outer surface of cowl 34).
Regarding claim 11, Davis discloses the cap assembly of claim 1, wherein the cap assembly is capable of maintaining a sterile field on the Luer-type fitting or vial stopper, when said cap assembly is in the closed position (forced compliance where the medical implement is disinfected every time use of the medical implement is desired, P0051, and the port of the medical implement is always covered, except during a very brief transition period when access to the medical implement is sought, P0052).
Regarding claim 12, Davis discloses the cap assembly of claim 1 wherein said disinfecting means is an absorbent pad containing a disinfectant (disinfectant pad 38, see definition of pad being absorbent).
Regarding claim 17, Davis discloses a kit comprising a cap assembly of claim 1 and at least one of an intravenous administration set (vascular catheter hubs and access or injection ports, P0002) having an injection port with a Luer-type fitting (luer ends, P0054 and Figs. 4-6).
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.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Dupont et al. (DuPont) US 2017/0274189 A1.
Regarding claim 13, Davis discloses the cap assembly of claim 1.
Davis does not teach wherein said disinfecting means is a UV-light source or UV light cell.
However, DuPont teaches an apparatus for cleaning catheter ports wherein said disinfecting means is a UV-light source or UV light cell (UV lamp, P0104).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the disinfecting means of Davis to include UV light for the purpose of additional or alternative cleaning, DuPont P0104.
Regarding claim 14, Davis discloses the cap assembly of claim 1, wherein said disinfecting means is an absorbent pad containing a disinfectant (disinfectant pad 38, P0037).
David does not teach wherein said disinfecting means additionally includes a UV-light source.
However, DuPont teaches an apparatus for cleaning catheter ports wherein said disinfecting means is a UV-light source or UV light cell (UV lamp, P0104).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the disinfecting means of Davis to include UV light for the purpose of additional or alternative cleaning, DuPont P0104.
Claims 1, 3-7, 10-12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Drmanovic US 2018/0064604 A1 in view of Davis.
Regarding claim 1, Drmanovic discloses a cap assembly (capping device 100, P0057 and shown in Fig. 7) capable of disinfectingly enclosing a Luer-type fitting of an injection port of an intravenous administration set or capable of enclosing a hypodermic needle-puncturable stopper (septum, P0002 and Fig. 2) on a single-dose stoppered vial containing sterile drug or diluent (medication vial, P0002, P0051-0052 and Figs. 1-2), said cap assembly comprising: a base having a first or bottom end configured to couple to the injection port or the stoppered vial (105 and 106, P0049) and a second or top end configured to receive cover (103 and 104, P0049), a cover (cover 101 and side wall 102, P0049) having an outer surface and an inner surface, said cover being moveable between an open position (Fig. 7) and a closed position (fully seated (resting, closed) position, P0048), and a disinfecting means (disinfecting pad 114, P0050) disposed on the inner surface of the cover (Fig. 7), wherein the disinfectant means is selected from an absorbent pad or adsorbent pad retaining a disinfectant (P0056), and an ultraviolet (UV)-light source, wherein said base and cover are hingedly (hinge 108, P0057) or pivotally affixed to one another wherein said hinge or pivot is spring-loaded such that the cover is biased in the closed position to form a self-closing cover (hinge 108 may keep the top cover 101 biased toward the closed position, P0057).
Drmanovic does not teach the biasing mechanism to be spring-loaded.
However, Davis teaches a needleless hub and disinfection device wherein the base and cap are pivotally affixed to one another and wherein the cap is biased to the closed position via a spring-loaded torsion spring 40 as shown in Figs. 4-6 and described in P0038.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biasing means of Drmanovic with a torsion spring as taught by Davis for the purpose of biasing the cap to the closed position, as taught by Davis P0038.
Regarding claim 3, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein the cap assembly is separate from and connectable to the single-use vial containing drug or diluent (Drmanovic, showing the cap assembly separate in Figs. 3 and 7 and connectable in Figs. 4-6).
Regarding claim 4, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein the cap assembly is formed integrally with (this is interpreted as a product by process claim limitation, see MPEP 2113(I), and here, the product of the claim is the same as the product of Drmanovic in view of Davis) and part of the injection port of an intravenous administration set (Drmanovic, Figs. 5-6).
Regarding claim 5, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein the cover, in its closed position, forms an airtight seal with the injection port or drug or diluent vial stopper (Drmanovic, seal to prevent leakage and evaporation, P0054).
Regarding claim 6, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein the cover comprises a flange (Drmanovic, side fin 109, P0057 and shown in Fig. 7) extending outwardly and away from the outer surface of the cover wherein the flange is configured for engagement by a finger or thumb of a user such that applied pressure to the flange hingedly opens the cover away from the closed position to an open position, exposing the stopper of the injection port or vial (Drmanovic, a provider may press the side fin 109 with his or her thumb, and the top cover 101 may open for medication withdrawal as a result, and release of the side fin 109 would cause the top cover 101 to close).
Regarding claim 7, Drmanovic in view of Davis teaches the cap assembly of claim 6, wherein the flange extends curvilinearly away from the cover to facilitate ergonomic engagement with the finger or thumb of the user (Drmanovic, Fig. 7).
Regarding claim 10, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein the cap assembly comprises a least one raised area (Drmanovic, pad extension 117, P0050 and shown in Fig. 3) formed on the cap, which matingly engages an opposing area on the base (Drmanovic, central hole of floor 104, P0050) to resist opening of the cover away from the base without external force being applied (pad extension 117 corresponds in size and shape to the size and shape of the central hole, P0050, and resists opening because pad extension 117 pivots out of the central hole requiring the pad extension 117 to deform somewhat).
Regarding claim 11, Drmanovic in view of Davis teaches the cap assembly of claim 1, wherein the cap assembly is capable of maintaining a sterile field on the Luer-type fitting or vial stopper, when said cap assembly is in the closed position (Drmanovic, sterile techniques, P0048).
Regarding claim 12, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein said disinfecting means is an absorbent pad containing a disinfectant (Drmanovic, P0056).
Regarding claim 15, Drmanovic in view of Davis teaches the method for protecting from microbial contamination and maintaining a sterile field on a stopper on a single-use vial containing a sterile drug or diluent (Drmanovic, medication vials can be made for a single or multiple uses P0001, and all embodiments of the invention may be used on medication vials penetrated with sharp objects, P0065), said method comprising: - providing a cap assembly of claim 1; - coupling the cap assembly to a single-use vial (Drmanovic, P0066); - opening the cover with one hand (Drmanovic, the vial may be held in a hand, a provider may press the side fin 109 with his or her thumb, and the top cover 101 may open for medication withdrawal as a result, P0057) to access stopper of a single-use vial (Drmanovic, P0067); - puncturing the vial stopper with a hypodermic needle (sterile needle, P0002) for delivery or retrieval of a fluid therethrough (Drmanovic, P0068); - disconnecting the needle from the vial stopper (inherent step required to allow the cover to return to the closed position, and provide the patient with the withdrawn medication, and P0002 references multiple uses); and - allowing the cover to spring-loadingly return (as modified by Davis) to the closed position thereby exposing said vial stopper to said disinfectant means (Drmanovic, P0069).
Regarding claim 16, Drmanovic in view of Davis teaches the method for converting a single-use vial containing sterile drug or diluent into a multi-use vial containing sterile drug or diluent (Drmanovic, medication vials can be made for a single or multiple uses P0001, and all embodiments of the invention may be used on medication vials penetrated with sharp objects, P0065), said method comprising: - providing a cap assembly of claim 1; - opening and using the single-use vial a first time (Drmanovic, P0051-0052 and Figs. 1-2); - coupling the cap assembly to the single-use vial over a puncturable stopper (septum, P0002) provided on the single-use vial (Drmanovic, Figs. 3-6, and P0066), wherein the cap assembly can be opened and closed a plurality of times for use as needed until the vial no longer contains a useful amount of sterile drug or diluent, and - closing the cover of the cap assembly following each use to prevent contamination and maintain a sterile field for the stopper (Drmanovic, forced compliance with aseptic techniques is achieved and the septum is always kept sterile, P0055).
Regarding claim 17, Drmanovic in view of Davis teaches the kit comprising a cap assembly of claim 1 and a single-use vial (Drmanovic, medication vials can be made for a single or multiple uses P0001, and all embodiments of the invention may be used on medication vials penetrated with sharp objects, P0065) containing sterile drug or diluent (Drmanovic, capping device for a medical container P0001 containing medications for intravenous use P0002).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Drmanovic in view of Davis in view of Rubino, JR. (Rubino) US 2020/0172303 A1.
Regarding claim 9, Drmanovic in view of Davis teaches the cap assembly of claim 1 wherein, upon closing of the cover to form an airtight seal (Drmanovic, seal to prevent leakage and evaporation, P0054).
Drmanovic in view of Davis does not teach a confirmatory feedback signal is audibly communicated to a user.
However, Rubino teaches a bottle with hinged lid that produces an audible “click” or other audible feedback, P0029.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify cap assembly of Drmanovic to provide audible feedback for the purpose of confirming to a user that the cap is fully closed, Rubino P0029.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783