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 .
Claims filed 3/31/2026 are acknowledged. Claims 1-5, 7, 10, 13, 15, 16, 19 are pending with claims 22-24, 31, 32, 38, 40, 43, and 45 being withdrawn.
Election/Restrictions
Applicant’s election without traverse of the invention of claims 1-5, 7, 10, 13, 15, 16, 19 in the reply filed on 3/31/2026 is acknowledged.
Claims 22-24, 31, 32, 38, 40, 43, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/31/2026.
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.
Claims 1-5, 7, 10, 13, 15, 16, 19 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.
With regards to claim 1, in light of the specification “wherein the NO donor molecule is released upon illumination” is confusing and indefinite. The invention appears to work by the donor molecule releasing NO upon the illumination of the polymer containing the donor molecule. This contradiction renders the claim indefinite.
Claim 3 also explicitly includes the same confusion again.
Dependent claims are rejected for the same reasons as the claims from which they depend.
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) 1-5, 7, 13, 15, 16, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frost (US 2015/0247005).
With regards to claim 1, Frost teaches a disinfection system capable of the intended use of disinfecting medical tubing (fig 7; NO is a known disinfectant and the coated light guide can be inserted into tubing of appropriate size to release NO there), comprising: a disinfection insert capable of the intended sue of extending within a lumen of medical tubing (the polymer coated light guide can be so inserted) comprising a fiber optic (para [0039], [0154], fig 7) and a polymer surrounding at least a portion of the fiber optic (coated) comprising a NO donor molecule (such as S-Nitrosothiols (RSNOs); para [0049], [0154]) where the NO donor molecules releases NO upon illumination of the polymer by the fiber optic (the polymer can be polysiloxane, PVC, or polyurethane; para [0105]; [00154]).
Additionally, since the taught polymer and the taught incorporated donor are the same (both teach RSNOs with polysiloxane or polyurethanes) their behavior when exposed to light would be similar.
With regards to claim 2, the NO donor molecule can be s-nitrosothiol (para [0049]).
With regards to claim 3, Frost teaches NO released at fluxes within the claimed range (table 1 in para [0157]; fig 11 and 12).
With regards to claim 4, the fiber optic is taken to be a side glow fiber optic (it is taught that the light illuminates the coating along the side of the fiber optic to release NO (fig 7, para [0154]; abstract; see whole document).
With regards to claim 5, the polymer is coated directly onto the fiber optic (it is a polymer coated fiber optic; para [0154] and fig 7).
With regards to claim 7, the polymer can be silicone rubber (polysiloxane) (para [0105]).
With regards to claim 13, the system further includes a light source (LED) in optical communication with the fiber optic and configured to selectively illuminate the fiber optic (off/on) (para [0141], [0157]; fig 7).
With regards to claim 15, the light source is capable of being removed from the insert (can be removed with at least enough effort).
With regards to claim 16, the light source delivers wavelengths within the claimed range (para [0034], fig 2).
With regards to claim 19, a microcontroller controls a light source by varying the current supplied (para [0149]). Varying the current affects the intensity of light (direct relationship) as well as the wavelength (para [0150]). Further, fig 7 shows the light profile being set via a controller which then wirelessly configures the LED. The NO generation is dependent on intensity and wavelength (abstract).
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.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Frost (US 2015/0247005) as applied to claim 1 above, and further in view of Lin et al. (WO 2015066238).
With regards to claim 10, Frost does not teach a fastener as acclaimed. Lin et al. teaches a sterilization device using a fiber optic (abstract). The fiber optic is insertable into the desired place to be sterilized and is held in place using a connector (70). Hub adapter (72) of the connector (70) fastens to a hub (5) of a catheter to sterilize the lumen (abstract; para [0061]). A person having ordinary skill in the art would have found it obvious to have used a fastener (connector 70 with hub adapter 72) in order to hold the fiber optic-based sterilizer device of fig 7 in place to treat a target area/device/lumen including the lumen of medical tubing (a catheter).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONALD R SPAMER whose telephone number is (571)272-3197. The examiner can normally be reached Monday to Friday from 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (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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/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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