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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested:
The title of the application, "Therapeutic Endotrachel System," appears to contain a
typographical error. The correct spelling is believed to be "Therapeutic Endotracheal
System." Applicant should submit an amendment to correct the title.
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 1 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.
Lack of Antecedent Basis - Missing Indefinite Articles
The claim introduces the elements "first body portion" and "second body portion" without
the required indefinite article ("a" or "an").
The claim recites "a first probe comprising first body portion..." This is improper as it is
the first introduction of this element. It should be "a first probe comprising a first body
portion..."
Similarly, the claim recites "a second probe comprising second body portion..." This
should be "a second probe comprising a second body portion..."
This lack of proper introduction for these elements renders the claim indefinite.
Ambiguous Antecedent Basis - Unclear References
The claim uses the definite article "the" to refer to elements that have ambiguous or
unclear antecedents, creating indefiniteness.
"the proximal end" and "the distal end" (First Probe): The claim recites "a first
trigger operatively coupled to the proximal end of the first body portion and
configured to move the distal end." At this point in the claim, multiple proximal and
distal ends have been introduced (for the tube and the first probe). The claim fails to
specify which proximal and distal ends are being referred to (e.g., "the first proximal
end" and "the first distal end"). This ambiguity makes it unclear what the trigger is
coupled to and what it moves.
"the proximal end" and "the distal end" (Second Probe): The same issue is repeated
for the second probe, which recites "a second trigger operatively coupled to the
proximal end of the second body portion and configured to move the distal end." The
claim fails to specify that it is referring to "the second proximal end" and "the second
distal end."
"the distal end" (Second Probe UVC Device): The claim recites "a second UVC light
emitting device disposed at the distal end of the second body portion." While context
suggests this refers to the second distal end, the claim has introduced multiple distal
ends, and the language is therefore technically ambiguous. It should specify "the
second distal end."
Inconsistent and Ambiguous Language
The claim uses inconsistent language to describe the location of the UVC light emitting
devices on the two probes, creating ambiguity as to the scope of the claim.
For the first probe, the UVC device is "disposed at a distal portion of the first body
portion."
For the second probe, the UVC device is "disposed at the distal end of the second body
portion."
This inconsistency raises questions as to whether the positioning of the two UVC devices is
intended to be different, and what the precise scope of "a distal portion" is in relation to
"the distal end." This renders the claim indefinite.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,179,530. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 [which includes all elements of claim 1] discloses:
“[t]he therapeutic intubation device of claim 1, wherein the controller is configured to control an exposure time, an exposure profile and a wavelength of UVC light.”
Moreover, claim 1 of the cited patent discloses:
“[a] therapeutic intubation device, comprising:
a tube having an elongate body having a tube proximal end and a tube distal end, the elongate body defining a first channel, between the tube proximal end and the tube distal end, a second channel along a length of the elongate body and a third channel along the length of the elongate body;
a first probe comprising first body portion comprising a first probe proximal end and a first probe distal end, a first trigger operatively coupled to the probe proximal end of the first body portion and configured to move the probe distal end, and a first ultraviolet-c (“UVC”) light emitting device disposed at a first probe distal portion of the first body portion, the first probe configured to be installed in the second channel of the tube, in response to actuation of the first probe and first trigger by a user, the probe distal end and the first UVC light emitting device is configured to be positioned beyond the tube distal end in a first bronchus of a patient;
a second probe comprising second body portion comprising a second probe proximal end and a second probe distal end, a second trigger operatively coupled to the second probe proximal end of the second body portion and configured to move the second probe distal end, and a second UVC light emitting device disposed at the second probe distal end of the second body portion, the second probe configured to be installed in the third channel of the tube, in response to actuation of the second probe and the second trigger by the user, the probe distal end and the second UVC light emitting device is configured to be positioned beyond the tube distal end in a second bronchus of the patient; and probe and the second trigger by the user, the probe distal end and the second UVC light emitting device is configured to be positioned beyond the tube distal end in a second bronchus of the patient.”
The above paragraph discloses (1) a tube, (2) a first probe having a first ultraviolet light emitting device to be positioned in a first bronchus of a patient, (3) a second probe having a second ultraviolet light emitting device to be positioned in a second bronchus of a patient, and (4) a controller.
Based on the above comments, in summary, although the claims at issue are not identical, they are not patentably distinct from each other.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Makhoul et al. (US 5,291,882; hereinafter “Makhoul”) in view of Lin et al. (WO2015066238; hereinafter “Lin”).
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In relation to claim 1, Makhoul shows in figure 1 above, a therapeutic intubation device comprising an elongate tube body having proximal and distal ends and defining a first channel (main lumen 18 extending between proximal and distal ends), a second channel (lumen 22 along the length), and a third channel (lumen 14 along the length). However, Makhoul does not disclose (1) insertable probes with UVC emitters, (2) triggers for distal movement, or (3) a controller for UVC emission.
Lin demonstrates that it would have been obvious to modify the multi-channel intubation tube of Makhoul [see figure 1 above] by incorporating first and second insertable fiber optic probes, each comprising a body portion with proximal and distal ends, a UVC light emitting device at the distal portion, along with a controller to control emission from at least one UVC device (paragraphs [0005]-[0010], [0020]-[0030], [0035]-[0045], [0050]-[0060]; Fig. 1-3) and triggers to move the probes proximally and distally.
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Lin shows in figures 1 and 11 above, insertable fiber optic probes (10, 12) for UVC delivery with a particular band of wavelengths of 250-280 nm (paragraph [0008]). Lin explicitly supports multi-lumen configurations with a second probe (see paragraphs [0011] [0033] [00107]; claim 3), a controller (90) for modulating emission intensity, pulsing, and timing to one or both probes, and a trigger (114/115) operatively coupled to the proximal end of each probe body and configured to move the distal end of each probe (paragraph [00174]; figure 11). Based on the above teachings, one of ordinary skill in the art would have been motivated to combine the teachings of Makhoul and Lin to enable targeted, in vivo UVC sterilization of endotracheal tubes via dedicated channels [lumens], reducing biofilm and infection risk without interfering with ventilation or monitoring functions, as Lin expressly addresses catheter-related bloodstream infections in breathing tubes like endotracheal devices (paragraph [0005]). Thus, all limitations of Claim 1 are taught or suggested by the combination, rendering it obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783