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 11/19/2025 has been received and claims 1-3, 5-13 and 15-20 are pending.
Election/Restrictions
Claims 11-13 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 1-3 and 5-10 are objected to because of the following informalities: in line 25 of Claim 1, delete “of the” and insert --of the--. 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.
Claims 1-3 and 5-10 are 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, in claim 1 there is no written description support for the newly added limitation that step of “characterizing one or more characteristics…[is] based on the identification of the medical device” within the Specification.
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 1-3 and 5-10 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 1, it is not clear how “one or more characteristics of at least an elongate portion of the medical device” can be characterized “based on the identification of the medical device”.
Claim 5 recites the limitation "the medical device characteristics" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the medical devices" in line 2. There is insufficient antecedent basis for this limitation in the claim.
In Claim 5, it is not clear whether the limitation “materials of the medical devices” is attempting to set forth a separate and distinct feature than the limitation in the parent claim 1 with respect to “at least a material of the medical device”.
In Claims 5-6, it is not clear how these claims can depend on a canceled claim (i.e. claim 4).
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 and 5-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neveu (20200360549).
As to Claim 1, Neveu (‘549) discloses a disinfection system (100a; 100b; 100c; 100d; 100e; 100f; 100g) for disinfecting medical devices (120; 128a,; 128b; 128c) (see entire document, particularly Figures 1A-1C and 6A-7), the disinfection system (100a; 100b; 100c; 100d; 100e; 100f; 100g) comprising:
one or more machine readable data readers (170, 172, 174) configured to read machine readable data associated with the medical data (see entire document, particularly p. 14 [0233]-[0234] and [0236]-[0237] , p. 15 [0238]);
a local database (168 in 164) or a shared database (i.e. via the Internet) of medical devices for establishing or maintaining vascular access in patients (see entire document, particularly p. 14 [0232]-[0233] last 5 lines, p. 15 [0238], [0241] – last 5 lines and [0242] – lines 16-19);
a console (160, 170) having electronic circuitry including memory (164) and one or more processors (162), the memory (164) including executable instructions (166) (see entire document, particularly Figure 7, p. 14 [0230]-[0234]) configured to cause the console (160) to perform various processes when executed by the one-or-more processors (162) including:
reading the machine readable data associated with the medical device (see entire document, particularly p. 15 [0238] and [0241]-[0244] particularly [0242] – specifically lines 16-19, and [10243]);
accessing the local database (168, 164) or the shared database of medical devices (see entire document, particularly Figure 7);
identifying the medical device in the local database of medical devices based on the machine readable data associated with the medical device (see entire document, particularly p. 15 [0241] particularly lines 1-3 and 14 and last 4 lines and [0242] – lines 1-6 and 16-19, p. 16 [0245]);
characterizing one or more characteristics of at least an elongate portion of the medical device (120; 128a,; 128b; 128c) based on the identification of the medical device (see entire document, particularly p. 15 [0241] and [0242] – lines 1-6 and 13-19), wherein the one or more characteristics capable of including at least a material of the medical device (e.x. identification information associated with target articles) (see entire document, particularly Figures 7-8, p. 15 [0241]-[0244] – particularly [0242] lines 13-19 and 26-27, p. 16 [0245]); and
determining a disinfection profile for disinfecting at least the elongate portion of the medical device with ultraviolet ("UV") light (i.e. step 812 - see entire document, particularly Figures 7-8, p. 15 [0246]-[0247], p. 15 [0242] – particularly lines 4-6 and 11-13), wherein the disinfection profile is based on at least the material of the medical device (e.x. identification information associated with target articles) (see entire document, particularly p. 15 [0242] – particularly lines 4-6, 11-13 and 26-27 and [0243]-[0244]); and
disinfecting at least the elongate portion of the medical device in accordance with the disinfection profile (via 178a) (see entire document, particularly Figure 7, p. 15 [0242], p. 16 [0246]); and
a disinfection unit (100) operably coupled to the console (160, 170), the disinfection unit (100) including:
a disinfection compartment (102, 114) suitably sized to enclose the medical device (120; 128a,; 128b; 128c; also within 130) therein (see Figures 1A-1C); and
a UV-light source (104) disposed in the disinfection compartment (102, 114) (see Figures 1B-1C) for disinfecting at least the elongate portion of the medical device (120; 128a,; 128b; 128c) (e.x.: step 812 - see Figure 8).
As to Claim 2, Neveu (‘549) discloses that the UV light source (104) is configured to emit UV light in a range from about 100 nm to 280 nm (see entire document, particularly p. 7 [0171], p. 9 [0180] – 4th – 8th lines from the bottom).
As to Claim 3, Neveu (‘549) discloses that the UV light source (104) is a low-pressure mercury lamp or a pulsed xenon lamp disposed in the disinfection department (102) (see entire document, particularly Figures 1b-1c, p. 7 [0172], pp. 7-8 [0174], p. 8 [0179]).
As to Claim 5, Neveu (‘549) discloses that the medical-device characteristics are capable of being selected from at least materials of the medical devices; properties of the materials; surface topographies, and expected contamination levels based on the materials (see entire document, particularly p. 15 [0241], p. 16 [0245]).
As to Claim 6, Neveu (‘549) discloses that the disinfection system (100a; 100b; 100c; 100d; 100e; 100f; 100g) further comprising: one or more machine-readable data readers (124) selected from a radiofrequency identification ("RFID") tag reader (see entire document, particularly p. 16 [0248] – 5th line from the bottom).
As to Claim 7, Neveu (‘549) discloses that the disinfection profile is capable of including an exposure time for the UV light, a power of the UV light, or a combination thereof (see entire document, particularly p. 16 [0246]).
As to Claim 8, Neveu (‘549) discloses that the disinfection system (100a; 100b; 100c; 100d; 100e; 100f; 100g) further comprising: an ultrasound probe (128 – 128a-128c) configured to emit ultrasound signals into a limb of a patient and receive echoed ultrasound signals from the patient's limb by way of a piezoelectric sensor array (see entire document, particularly p. 9 [0187]), the various processes (166 – 166a, 166b) performed by the console (160) further capable of including transforming the echoed ultrasound signals to produce ultrasound images (e.x.: 186a, 186b).
As to Claim 9, Neveu (‘549) discloses that the disinfection compartment (102, 114) is further suitably sized to enclose the ultrasound probe (128 – 128a-128c) (e.x. enclosed in 130) therein for disinfection of the ultrasound probe (128 – 128a-128c) between uses thereof (see Figures 1A-1C and 6A-6D).
As to Claim 10, Neveu (‘549) discloses that the disinfection system (100a; 100b; 100c; 100d; 100e; 100f; 100g) further comprising: a display integrated into the console or a monitor operably connected to the console (see entire document, particularly p. 14 [0234]-[0235]), the various processes performed by the console further including sending display signals (via 160, 162) to the display for displaying disinfection-related information selected from at least medical-device identification, disinfection state, and a disinfection-progress indicator (see entire document, particularly p. 14 [0234]-[0235]).
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
Specifically, as to applicant’s argument in last 3 lines on p. 9 to line 7 on p. 10 of Remarks, examiner points out that the information of target article identifier(s) along with additional information associated with the identifier/identification information (see Neveu, p. 15 [0242] – lines 13-19) would/capable to include characteristic(s) of the target article such as material composition of the article so as to ensure that the only correct/suitable disinfection algorithm is executed (see Neveu, p. 15 [0242] – lines 3-6 and 11-13).
As to applicant’s argument on p. 10 of Remarks with respect to radio circuits/radio frequency (RF) transmitter/receiver pairs of Neveu, examiner indicates that applicant’s argument is merely directed to a capability/recitation of the intended use of the claimed invention and that there must be/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.
As to applicant’s argument in the first full paragraph on p. 11 of Remarks, examiner disagrees and points out that the limitation of “identifying…in the local database or the shared database…based on the machine readable data” is carried out by the console rather than by the one or more machine readable data readers. In addition, examiner indicates that applicant’s argument is merely directed to a capability/recitation of the intended use of the claimed invention and that there must be/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. In particular, the structure disclosed by Neveu (i.e. radio circuits/radio frequency (RF) transmitter/receiver pairs) is not structurally different than the one or more machine readable data readers such as a radiofrequency identification (“RFID”)-tag reader.
Finally, as to applicant’s argument in the second full paragraph on p. 11 of Remarks, examiner disagrees and points out that a memory is a known location for/to store information such as a database (e.x. “read-only portion of memory” – Neveu (‘549) – p. 15 [0241] – 3rd – 4th lines from the bottom) and that the argument is merely directed to a recitation of the intended use of the claimed invention and that there must be/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.
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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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