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 .
DETAILED ACTION
Response to Amendment
The amendment filed on 5/13/2026 has been received and claims 1-10 and 21-27 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/16/2026 has been entered.
Claim Objections
Claims 24-26 are objected to because of the following informalities:
in line 1 of Claim 24, insert --disinfection-- before “device”;
in line 1 of Claim 25, insert --disinfection-- before “device”;
in line 3 of Claim 25,
insert --color-changing-- before “material”, and
insert --disinfection-- before “device”;
in line 1 of Claim 26, insert --disinfection-- before “device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is no written description support for the limitation that the disinfection device also comprises “a camera” in addition to the transceiver (claimed in the parent claim 9) within the Specification as the disclosure appears to teach that one of “a sensor, a camera, RFID reader, …, or transceiver” is included “to aid in the identification of an attached hub (see Specification, p. 8 [0036] – lines 1-3).
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 26-27 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.
In Claim 26, it is not clear whether “an airtight package” is a component of the disinfection device as it appears to be merely a means for protecting/transporting the claimed device and not a structure/component of the disinfection device.
In Claim 27, it is not clear whether there is an additional structure/component of a camera present in addition to the transceiver as set forth in parent claim 9.
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.
Claim(s) 1-3, 6-8, 21 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swaney (10610609).
As to Claim 1, Swaney (‘609) discloses a disinfection device (100) for disinfecting a hub (106) of a medical device (126) (see Figures 1-5), comprising:
a housing (102) extending between a first end and a second end, the housing (102) containing:
a power source (112); and
an ultraviolet light source (120);
a connection mechanism (130) located at the first end of the housing (102);
a sterile adapter (104) attached to and disposed in contact with the housing (102) via the connection mechanism (130) (see entire document, particularly Figures 2-5, Col. 5 lines 14 and 25-36), the sterile adapter (104):
configured to couple with the hub (106) of the medical device (see entire document, particularly Figures 2-5), and
including a threaded proximal end configured to attach the sterile adapter (104) to the housing (102) (see entire document, particularly Figure 4, Col. 12 lines 31-32),
wherein:
a disinfection process of the disinfection device (100) is configured to disinfect the hub (106) (see entire document, particularly Col. 3 line 48 to Col. 4 line16, Col. 5 lines 44-57), and
the hub (106) includes a male Luer connector or a female Luer connector (see entire document, particularly Col. 5 lines 17-24).
As to Claim 2, Swaney (‘609) discloses that the ultraviolet light source (120) is a light emitting diode with a peak of wavelength within the range of 100-400 nanometers (nm) (see entire document, particularly Col. 7 lines 61-64, Col. 8 lines 1-8, 36-50 and 53-57).
As to Claim 3, Swaney (‘609) discloses that the connection mechanism (130) includes one or more of a screw thread, a channel, ridge, a friction fit connector, a magnet, or a ferromagnetic material (see entire document, particularly Figures 2-5, Col. 5 lines 14 and 17-36).
As to Claim 6, Swaney (‘609) discloses that the sterile adapter (104) configured for attachment to the male Luer connector or the female Luer connector (see entire document, particularly Figures 2-5, Col. 5 lines 17-36 specifically lines 17-24).
As to Claim 7, Swaney (‘609) discloses that the disinfection device (100) further comprising: at least one indicator (110) being one or light emitting diodes (LEDs) configured to indicate either a power level of the power source or a status of the disinfection process (see entire document, particularly Figures 1 and 5, Col. 5 line 58 to Col. 6 line 29).
As to Claim 8, Swaney (‘609) discloses that the sterile adapter (104) is configured to transmit ultraviolet light from the ultraviolet light source to the male Luer connector or the female Luer connector (see entire document, particularly Figures 1-5. Col. 5 lines 17-36 specifically lines 17-24).
As to Claim 21, Swaney (‘609) discloses that the connection mechanism (130) includes a magnet, or a ferromagnetic material (see entire document, particularly Col. 5 lines 27-28 and 33-34).
As to Claim 24, the disinfection device (100) of Swaney (‘609) is capable to disinfect itself between uses.
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.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Swaney (10610609).
Swaney (‘609) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
While Swaney (‘609) discloses that the power source (112) is rechargeable and that the rechargeable battery (120) is recharged (see entire document, particularly Col. 7 line 29), Swaney (‘609) does not appear to specifically teach that the disinfection device is further comprises of a port located on the second end, wherein the one or more port is configured for coupling to an external device and receiving a charge or power supply from the external device/ However, it would have been well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide a port located on the second end that is configured for coupling to an external device and receiving a charge or power supply from the external device in the disinfection device of Swaney as a known component in order to recharge the battery so as to ensure that the disinfection device is operational. Only the expected results would be attained.
Claim(s) 5, 9-10, 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney (10610609) as applied to claim 1 above, and further in view of Etter (20200188543).
Swaney (‘609) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
While Swaney (‘609) teaches that the power source in the form of a rechargeable battery (112) (see entire document, particularly Col. 7 lines 29-30, where a device with a recharging/rechargeable battery may intrinsically comprise an induction coil), Swaney (‘609) does not appear to specifically teach that the power source is a capacitor or an induction coil.
It was known in the art before the effective filing date of the claimed invention to provide an induction coil as a component of a power source in a disinfection device. Etter (‘543) discloses a disinfection device (300) for disinfecting a hub of a medical device, comprising:
a housing (i.e. body of 300) extending between a first end and a second end (see Figure 3A), the housing (i.e. body of 300) containing a power source in the form of an induction coil (see entire document, particularly Figures 3A-5F and Figures 8F-8G, p. 8 [0156] and [0158] – lines 4-8 specifically line 8), and an ultraviolet light source (132, 120) (see entire document, particularly Figures 1D-1F, p. 7 [0148]-[0149]), and
a transceiver, in the form of a RFID transmitter or transceiver, configured to obtain an identifier from the medical device (see entire document, particularly p. 23 [0309] – lines 16-17 and 28-31), wherein the identifier is capable of indicating a preprogrammed disinfection regimen to be performed by the disinfection device (300), and
a camera to aid in identifying the medical device (see entire document, particularly p. 23 [0309] – lines 18-19 and 23-27),
wherein the disinfection device (300) is configured to disinfect itself between uses (see entire document, particularly p. 8 [0152] – lines 13-16),
in order to charge the rechargeable batteries within the disinfection device (see entire document, particularly p. 8 [0158] – lines 6-8 and 10-12).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide an induction coil as component of a power source for the disinfection device of Swaney as a known power component in order to enable charging of rechargeable batteries as shown by Etter.
Thus, Claims 5, 9-10, 24 and 27 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Swaney (‘609) and Etter (‘543).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney (10610609) as applied to claim 1 above, and further in view of Etter (20210113725).
Swaney (‘609) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
While As to Claim 10, Swaney (‘609) discloses a transceiver includes RFID transmitter or transceiver (see entire document, particularly Col. 11 lines 51-59).
Swaney (‘609) does not appear to specifically teach that the disinfection device further comprises a transceiver configured to obtain an identifier from the medical device wherein the transceiver includes either an RFID or BLUETOOTH® enabled transmitter or transceiver.
It was known in the art before the effective filing date of the claimed invention to provide a transceiver in the form of an RFID transmitter in a disinfection device. Etter (‘725) discloses a disinfection device (100; 500) for disinfecting a hub (602) of a medical device (see Figures 1-62E) comprising:
a housing (102) having a first end (i.e. where 108 is located) and a second end (i.e. where 116 is located);
a power source (136);
an ultraviolet light source (132);
a connection (106);
a sterile adapter (104) coupled with the disinfection device and configured to couple with the hub (602) of the medical device (see Figures 6 and 16A),
wherein:
a disinfection process of the disinfection device is configured to disinfect the hub (see entire document, particularly Abstract), and
the hub is capable of including a male Luer connector or a female Luer connector (see Figures 6 and 16A); and
a transceiver (118) configured to obtain an identifier from the medical device, wherein the identifier indicates a preprogrammed disinfection regimen to be performed by the disinfection device (see entire document, particularly pp. 10-11 [0172]),
wherein the transceiver (118) includes either an RFID or BLUETOOTH® enabled transmitter (see entire document, particularly p. 3 [0021], pp. 7-8 [0148], p. 15 [0215], p. 22 [0287], p. 23 [0298])
in order to ensure appropriate disinfection cycle/program is utilized for each hub (see entire document, particularly pp. 10-11 [0172]).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a transceiver that includes either an RFID or Bluetooth enabled transmitter in the disinfection device of Swaney as a known component in order to ensure that a correct disinfection cycle is utilized for each hub as shown by Etter.
Thus, Claims 9-10 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Swaney (‘609) and Etter (‘725).
Claim(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney (10610609) as applied to claim 1 above, and further in view of Cohen (20150165185) or Alwan (20130323119).
Swaney (‘609) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
As to Claim 22, Swaney (‘609) does not appear to specifically teach that the sterile adapter includes fibers to transmit the ultraviolet light from the disinfection device to the male Luer connector or the female luer connector.
It was known in the art before the effective filing date of the claimed invention to provide fibers to transmit ultraviolet light from a disinfection device. Cohen (‘185) discloses a disinfection device (110) for disinfecting a hub of a medical device (see entire document, particularly Figure 2, p. 2 [0022]), comprising:
a housing (30)/sterile adaptor extending between a first end and a second end, the housing containing:
a power source (14),
an ultraviolet light source (112), and
fibers (150) (see entire document, particularly p. 3 [0030]-[0031]);
wherein:
a disinfection process of the disinfection device is configured to disinfect the hub see entire document, particularly Figure 2, p. 1 [0002] and [0012], p. 2 [0022];
in order to transmit ultraviolet light to desired/specific locations within the housing/sterile adapter (see entire document, particularly p. 1 [0012], p. 3 [0030] – lines 5-7 and [0031]).
Alwan (‘119) also discloses a disinfection device (100) for disinfecting a hub (34) of a medical device (see entire document, particularly Figures 4A-4B, p. 3 [0038]), comprising:
a housing (102) extending between a first end and a second end, the housing (102) containing an ultraviolet light source (see entire document, particularly p. 3 [0036] – lines 8-9) and intrinsically a power source (i.e. to enable generation of UV light);
a connection mechanism (106) located at the first end of the housing (102); and
a sterile adapter (104) attached to and disposed in contact with the housing (102) via the connection mechanism (106), the sterile adapter (104) configured to couple with the hub (34) of the medical device (see Figures 4A-4B),
wherein:
the sterile adapter (104) includes fibers (107a, 37) (see Figure 4C),
a disinfection process of the disinfection device is configured to disinfect the hub, and
the hub includes a male Luer connector or a female Luer connector (),
in order to convey UV light from the light source to the sterile adapter and disperse/direct the UV light within the sterile adapter onto various surfaces of the hub (see entire document, particularly p. 3 [0036] – lines 8-13 and [0038] – lines 6-12).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide fibers in the sterile adaptor of the disinfection device of Swaney as a known component in order to transmit then direct ultraviolet light from the ultraviolet light source to a desired/specific area(s) for disinfection as shown by Cohen or Alwan.
As to Claim 23, Swaney (‘609) discloses that the ultraviolet light source (120) is disposed behind a lens such that the fibers (of Cohen or Alwan) transmit the ultraviolet light from the ends to the male luer connector or the female luer connector (see entire document, particularly Figure 3, Col. 5 lines 37-39).
Thus, Claims 22-23 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Swaney (‘609), and Cohen (‘185) or Alwan (‘119).
Claim(s) 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney (10610609) as applied to claim 1 above, and further in view of Doyle (20170173251).
Swaney (‘609) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
Swaney (‘609) does not appear to specifically teach that the disinfection device includes a color-changing material configured to change color in response to prolonged exposure to air or a liquid, the color-changing material useful in communicating to a user that the disinfection device has been previously used, or that the disinfection device is disposed in an airtight package configured to preserve an initial color of the color-changing material.
It was known in the art before the effective filing date of the claimed invention to provide a color-changing material in an airtight packaging with a device. Doyle (‘251) discloses a system comprised of a device/sterile adapter (20) and a color-changing material (i.e. color change type indicator) configured to change color in response to prolonged exposure to air (i.e. air breach) or a liquid (i.e. contaminants) (see entire document, particularly p. 14 [0128] – lines 16-20), the color-changing material (i.e. color change type indicator) useful in communicating to a user that the device/adapter (20) has been contaminated/previously used, wherein the device/sterile adapter (20) is disposed in an airtight package (see entire document, particularly p. 14 [0128] – lines 9-10 and 14-15) configured to preserve an initial color of the color-changing material (i.e. color change type indicator) (see entire document, particularly p. 14 [0128] – lines 14-20), in order to provide an indication of/information on the status of the device/sterile adapter utilized with a medical device (see entire document, particularly p. 14 [0128] – lines 14-20). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a color-changing material in an airtight packaging with the disinfection device of Swaney as a known components of a medical device connection system/assembly so as to allow visualization of a status/information of a device/sterile adapter to be utilized with a medical device/connection as shown by Doyle.
Thus, Claims 25-26 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Swaney (‘609) and of Doyle (‘533).
Response to Arguments
Applicant's arguments filed 5/13/2026 have been fully considered but they are not persuasive. Specifically, as to applicant’s argument in the second paragraph on p. 6 of Remarks, examiner disagrees and points to the rejection of claim 1 in paragraph 11 above where Swaney does disclose a configuration where the adapter 104 is connected to the body 102 with “a threaded proximal end” which is intrinsically necessary when the adapter 104 is “screwed into [the body 102/]device 100 at port 128.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: CN108430533 (Chinese equivalent to 20170173251), WO2020167843 (a sterilization device for luminal connection ports and vials, including vial caps), 20200254121 (an instrument sterilization device comprised of a substrate/liquid that changes color after completion of sterilization or exposure to UV light), WO2011107540 and WO20211466673 (a connector/adaptor using UV light source).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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