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 .
Claim amendments filed 8/31/2026 are acknowledged. Claims 1-5, 10, 13, 15, 16, 19, 46, 47, and 49 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/31/2026 has been entered.
Response to Arguments
Arguments filed 8/31/2026 have been considered.
The applicant correctly points out that Frost does not teach any embodiments with the NO donor molecule not covalently bonded to the polymer.
The applicant misconstrues the takeaway from para [0139]. The paragraph does not generally teach never to not have a covalently bonded NO donor molecule. Instead, it teaches that in that setup the NO donor molecule S-nitrosothiol was not formed or present. Not having the donor molecule present, while definitely would not work as intended, is different from not having a covalently bonded donor molecule.
Toone et al. teaches preparing a NO-releasing composition/coating (abstract). The NO releasing compound can be the same as in Frost such as SNAP and S-nitrosotiols (para [0050]). The NO releasing compound is incorporated into a polymer to form the article/coating either by entrapment or by chemical bond (para [0052]-[0053]). A person having ordinary skill in the art would have found it obvious to have substituted one means of incorporating the NO releasing compound in the coating/polymer (entrapment) for another (chemical bond) motivated by an expectation of successfully providing an NO releasing composition for sterilizing.
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) 1-5, 7, 13, 15, 16, 19, 46, 47, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frost (US 2015/0247005) in view of Toone et al. (US 2001/0000039).
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.
The NO donor is covalently bonded to the polymer (para [0127] etc.) in Frost. Toone et al. teaches preparing a NO-releasing composition/coating (abstract). The NO releasing compound can be the same as in Frost such as SNAP and S-nitrosotiols (para [0050]). The NO releasing compound is incorporated into a polymer to form the article/coating either by entrapment or by chemical bond (para [0052]-[0053]). A person having ordinary skill in the art would have found it obvious to have substituted one means of incorporating the NO releasing compound in the coating/polymer (entrapment) for another (chemical bond) motivated by an expectation of successfully providing an NO releasing composition for sterilizing.
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).
With regards to claim 46, the polymer can be polydimethylsiloxane (para [0033], [0084]).
With regards to claim 47, the donor molecule can be SNAP (para [0043]).
With regards to claim 49, the polymer can be polysiloxanes including polydimethylsiloxane (para [0033], [0084]). Polysiloxane is another name for silicone rubber.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Frost (US 2015/0247005) and Toone et al. (US 2001/0000039) 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
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/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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