DETAILED ACTION
1. 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
2. Applicant’s election of group I, claims 1-30 in the reply filed on 9/8/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 31-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/2025.
Claim Rejections - 35 USC § 102
3. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
4. Claims 1-2, 4, and 6-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bentley et al. (US 2017/0333680 A1) (hereafter “Bentley”).
Regarding claim 1, Bentley discloses (figure 1; para [0018]-[0019]) a system (catheter protection device 100) for improving central line hygiene, including a chamber (space formed by first and second housing portions 102, 104) for containing central line hubs (201) such that said chamber provides a barrier to said central line hub and protects said central line hubs from germs (see para [0025]; [0004]-[0006]).
Regarding claims 2 and 4, Bentley discloses wherein said chamber includes two concave halves (102, 104) forming a clamshell design operatively attached through a flexible living hinge (see figure 1; para [0021]).
Regarding claim 6, Bentley discloses that the chamber is made of a material chosen from the group consisting of polyamide, polyoxymethylene, polypropylene, acrylonitrile butadiene styrene, polycarbonate, and UV-transmissive acrylic (Bentley discloses in para [0019] that the housing is made from a rigid polymer, flexible polymer, foam, paper, or any other suitable material).
Regarding claims 7-8 and 22, Bentley discloses wherein said chamber further includes a skin (absorbent material 112 that lines an interior of the chamber and is made of foam and impregnated with silver or other antimicrobial agents) operatively attached to a location chosen from the group consisting of an outside of said chamber, an inside of said chamber, and both an outside and an inside of said chamber (see para [0028] and figure 2; absorbent material 112 lines and interior of the chamber).
Regarding claims 9-10, Bentley discloses wherein the skin (112) includes radiusing and chamfering (see figures 1-2 which show both radiusing and chamfering due to the shape of the housing) and affects a seal of the chamber (skin 112 contacts a seal/gasket located on the port holes (see para [0027]).
Regarding claim 11, Bentley discloses wherein said chamber further includes a latch (110A) at a side opposite said hinge for sealing said chamber (see figure 1; para [0020]).
Regarding claim 12, Bentley discloses wherein said latch (110A) includes a mode chosen from the group consisting of single-use mode, re-closable mode, rapid-release mode, child-resistant mode, and combinations thereof (Bentley discloses that the latch is child resistance and recloseable – see para [0020]).
Regarding claim 13, Bentley discloses wherein said chamber (space formed by first and second housing portions 102, 104 or 402, 404 as shown in figure 4) includes at least one sub-chamber (lower portion of the chamber not occupied by the catheter lines) for housing a sensor or burstable material (see para [0031] – lower portion of chamber (sub-chamber) is capable of housing a sensor or burstable material in the unoccupied space).
Regarding claim 14-17, Bentley discloses (para [0026]-[0027]) that the device (100) includes at least two ports (for example 106A, 106B) for enabling tubing to enter the chamber (see figures 1-4) and wherein the chamber is capable oof operating in a through mode or terminated mode if desired.
Regarding claim 18, Bentley discloses wherein said portals are formed by opposing semi-circles set into each half of said concave halves (see ports formed in walls of the chamber halves as shown in figures 1-4).
Regarding claim 19-21, Bentley discloses (see para [0027]) wherein said semi-circles (108A-108D) include a sealing mechanism (gasket) to seal said tubing wherein said sealing mechanism includes tethered plugs (gasket has bristles or fingers that seal the port when not in use) for sealing without tubing. The sealing mechanism (gasket) is made of a soft elastomer.
Regarding claim 23, Bentley discloses wherein said chamber of the device (100) includes an observation aperture (see figures 1-2; an unoccupied port 106A or 106B) are considered to be observation apertures when not containing a catheter line).
Regarding claim 24, Bentley discloses (see para [0028]) wherein said chamber includes a leak-responsive coating (absorbent material 112 that lines an interior of the chamber and is made of foam or fabric) that provides a change in shape in response to contact with fluid (foam and fabrics expand when contacted with a fluid).
Regarding claim 25, Bentley discloses in figure 2 a burstable material (hub 201) that is released into said chamber upon closure (the hub (201) is capable of being burst when the thickest portion of the hub is placed on the port (208A) and then the two halves (202, 204) are closed with sufficient force to break or burst the hub (201)).
5. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campagna (CA 2763710 A).
Regarding claim 1, Campagna discloses a system (2) (see figure 2) capable of being used to improve central line hygiene, including a chamber (8) capable of containing central line hubs such that said chamber (8) provides a barrier to said central line hub (when the chamber door 54 is closed) and protects said central line hubs from germs (see figure 2; see page 7, line 20 to page 8, line 5 – Campagna discloses that chamber (8) includes UV lights (6) which are used to disinfect an object paced in the chamber).
Claim Rejections - 35 USC § 103
6. 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.
7. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bentley as applied to claim 2 above, and further in view of Andersen et al. (WO 2020/200389 A1).
Bentley is set forth above with regards to claim 2 and teaches that the clamshell is connected with a living hinge but not a hinge pin.
Andersen et al. discloses a clamshell UV disinfection device (1) wherein two halves are connected by a hinge, wherein the hinge (5) can be a flexible living hinge or a hinge pin (see page 6, lines 27-30; page 7, lines 5-11; figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Bentley and substitute the living hinge with a functionally equivalent alternative hinge such as a hinge pin as disclosed by Andersen et al. whom teaches that pin hinges and living hinges are functionally equivalent in the art of UV clamshell disinfection devices.
8. Claims 26-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Campagna (CA 2763710) as applied to claim 1 above, and further in view of Harmon et al. (US 8,105,532 B2) (hereafter “Harmon”).
Campagna is set forth above with regards to claim 1 and teaches that the system further includes a UV wand that is connected to a socket (26) thus providing power to the wand and the controller sends instructions via the socket (26) in order to irradiate the interior of the chamber and increase sterilization (see page 10, lines 14-20; page 16, lines 20-30 – the wand automatically recognizes the chamber via the controller). However, Campagna does not disclose any specifics regarding the wand including if it is capable of measuring parameters.
Harmon discloses a UV disinfecting wand (100) wherein the wand incudes an array of UVC LED’s (see col. 8, lines 28-37). The wand (100) further includes a distance detector for calculating an intensity of light from the source on a target surface (see abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Campagna, particularly the UV wand, to include a UV wand having an array of UVC lights and a distance sensor in order to optimize the intensity of sterilizing light and improve the overall effectiveness of the sterilization process as taught by Harmon.
9. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Campagna in view of Harmon as set forth above with regards to claim 26, and further in view of He (CN 20150180137 A – English translation).
Campagna in view of Harmon is set forth above with regards to claim 26 but does not appear to disclose wherein said chamber includes a pigmented region that fluoresces upon exposure to said wand.
He discloses a disinfection chamber that comprises UV LED’s for disinfection of an object placed in the chamber. The chamber further includes a fluorescent substance that is excited by UV light in order to judge the working state of the UV LED in the chamber (see English translation).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the system of Campagna and provide the chamber with a pigmented region that fluoresces upon exposure to UV light from the wand in order to ensure proper operation of the UV LEDs as taught by He.
Allowable Subject Matter
9. Claim 5 is 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or fairly suggest wherein said hinge includes a sensor and electronics for detecting and recording opening and closing of said chamber, in the claimed environment. The closest prior art to the claimed invention is Bentley (of record) whom teaches an antimicrobial catheter hub which includes a hinge (see figure 1; para [0021]). However, there is no teaching or suggestion to modify Bentley to include a hinge that includes a sensor and electronics for detecting and recording opening and closing of said chamber, in the claimed environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E CONLEY whose telephone number is (571)272-8414. The examiner can normally be reached on M-F, 8:30am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN E CONLEY/Primary Examiner, Art Unit 1799