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 .
FINAL ACTION
Response to Amendment
The amendment filed on 12/10/2025 has been received and claims 1-22 are pending.
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/15/2025.
Claim Objections
Claims 1-10 and 21-22 are objected to because of the following informalities:
in line 4 of Claim 1, delete “;” after “containing” and insert --:--;
in line 5 of Claim 1, delete “;” after “source” and insert --,--;
in line 2 of Claim 22, delete “100”.
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.
Claim 10 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 10 recites the limitation "the transceiver" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 5-8, 10 and 21 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),
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 5, Swaney (‘609) discloses that the power source (112) is a battery or induction coil (see entire document, particularly Col. 6 lines 38-47, Col. 7 lines 29-30).
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 10, Swaney (‘609) discloses a transceiver includes RFID transmitter or transceiver (see entire document, particularly Col. 11 lines 51-59).
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).
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) 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).
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 is 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).
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.
Thus, Claim 22 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).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the same 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 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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/REGINA M YOO/ Primary Examiner, Art Unit 1758