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 .
Election/Restrictions
Applicant’s election without traverse of Group I, pertaining to Claims 1 – 29, and Species A, pertaining to Claims 1 – 15 and 28 – 29, in the reply filed on 12 January 2026 is acknowledged. The Claims that pertain to both Group I and Species A are Claims 1 – 15, 28, and 29.
Claim(s) 16 – 27 and 30 – 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 January 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Here the “germicidal irradiation means” recited in Claim 1 is being interpreted as internal radiation sources, external radiation sources, or other similar structures.
Claim Objections
Claims 6 and 10 are objected to because of the following informalities:
Claim 6 recites “of introducer sheath.” The Examiner suggests amending this to recite “of the introducer sheath” to provide the proper antecedent basis for this claim limitation.
Claim 10 recites “of introducer sheath.” The Examiner suggests amending this to recite “of the introducer sheath” to provide the proper antecedent basis for this claim limitation.
Appropriate correction is required.
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, 2, 7, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arcand et al. (US 2012/0161032 A1; hereinafter referred to as “Arcand”).
With regards to claim 1, Arcand discloses (Fig. 1) a catheter-disinfecting system (see Fig. 1), comprising:
an introducer sheath (10, 20) (see [0022]) including:
a sheath body (10) configured to be percutaneously inserted into an insertion site of a patient (see [0021]); and
a sheath hub (20) coupled to a proximal portion (11) of the sheath body (see [0022]); and
a germicidal irradiation means (100) (see [0024]) for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site (Here the claim language of “a germicidal irradiation means for irradiating a catheter tube of a catheter with a germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim and is to be limited by structural limitations. MPEP 2114. The Office submits that the germicidal irradiation means of Arcand meets the structural limitations of the claim and is capable of irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site. Support for this capability is found within at least the abstract and paragraphs [0015], [0024], and [0025] of Arcand).
With regards to claim 2, Arcand discloses the claimed invention of claim 1 and Arcand further discloses (Fig. 1) wherein the germicidal irradiation means (100) (see [0024]) includes one or more internal radiation sources (see [0024] “LED lamp units 100”) incorporated into the introducer sheath (see [0022] – [0023] and Fig. 1 which shows the LED lamp units inserted into the housing assembly 20), the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen of the introducer sheath (see abstract and paragraphs [0015], [0024], and [0025]).
With regards to claim 7, Arcand discloses the claimed invention of claim 2 and Arcand further discloses (Fig. 1) wherein the one-or-more internal radiation sources (100) (see [0024]) are incorporated into the sheath hub (20) (see [0022]) for circumferentially irradiating the lumen of the introducer sheath (see Abstract, [0015], [0024], and [0025]).
With regards to claim 28, Arcand discloses the claimed invention of claim 1 and Arcand further discloses (Fig. 1) wherein the germicidal radiation is selected from broad spectrum ultraviolet ("UV")-visible ("vis") light, broad spectrum UV light, UVA light, UVB light, UVC light, blue light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof (see [0024] “multiple LED lamp units 100 are shown emitting a sterilizing UV frequency light. Sterilizing UV frequency light can include UV-A, UV-B, and UV-C frequency light.”).
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) 1 – 3, 7, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerr (US 2014/0257186 A1) and Rioux et al. (US 2020/0261610 A1; hereinafter referred to as “Rioux”).
With regards to claim 1, Kerr discloses (see Figs. 1 – 2) a catheter-disinfecting system (see Fig. 2), comprising:
an introducer sheath (12) (see [0038]) including:
a sheath body (22) (see [0037]) configured to be percutaneously inserted into an insertion site of a patient (see [0037] “an instrument for forming an initial pathway through a patient’s skin layer, and underlying tissue, shown as an introducer 12”); and
a sheath hub (31) coupled to a proximal portion (24) of the sheath body (see [0047]).
However, King is silent with regards to the catheter-disinfecting system further comprising:
a germicidal irradiation means for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site.
Nonetheless Rioux, which is within the analogous art of sterilizable indwelling catheters (see title and abstract), teaches (Figs. 4, 5, and 9) a germicidal irradiation means (230, 232) (see [0046] “light having a wavelength of interest is introduced into the catheter tube 220 via port 224, for example, by inserting a light emitting component 230 (e.g., a light source, a light guide conveying light from a light source, etc.) into the port 224 as shown in FIG. 1C” and [0054] “A plurality of light sources 232 (e.g., LEDs) are embedded within the hollow shaft 220. These light sources 232 are electrically interconnected and powered by a power source 300 via line 310.”) for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath (204, 220), thereby disinfecting the catheter tube immediately before insertion into the insertion site (Here the claim language of “a germicidal irradiation means for irradiating a catheter tube of a catheter with a germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim and is to be limited by structural limitations. MPEP 2114. The Office submits that the germicidal irradiation means of Rioux meets the structural limitations of the claim and is capable of irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site. Support for this capability is found within at least the Abstract and paragraphs [0003] – [0005], [0039], and [0046] of Rioux).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify either the introducer sheath or the sheath hub of the catheter-disinfecting system of Kerr in view of a teaching of Rioux such that either the introducer sheath or the sheath hub comprise a germicidal irradiation means for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site. One of ordinary skill in the art would have been motivated to make this modification because Rioux teaches that the incorporation of a germicidal irradiation means within either the introducer sheath or sheath hub allows for the inactivating of microorganisms within the lumen of the introducer sheath (see abstract, [0003] – [0005], [0039], and [0046] of Rioux). The inactivation (i.e., either killing or preventing from reproducing) of microorganisms is beneficial as it would allow for the lumen of the introducer sheath and whatever else is inserted through the introducer sheath to be sterilized prior to insertion within the patient’s vasculature.
The catheter-disinfecting system of Kerr modified in view of a teaching of Rioux will hereinafter be referred to as the catheter-disinfecting system of Kerr and Rioux.
With regards to claim 2, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 1, however, Kerr is silent with regards to wherein the germicidal irradiation means includes one or more internal radiation sources incorporated into the introducer sheath, the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen of the introducer sheath.
Nonetheless Rioux, which is within the analogous art of sterilizable indwelling catheters (see title and abstract), teaches (Fig. 9) wherein the germicidal irradiation means (230, 232) (see [0054]) includes one or more internal radiation sources (see [0054] “A plurality of light sources 232 (e.g., LEDS) are embedded in the hollow shaft 220”) incorporated into the introducer sheath (204, 220), the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen of the introducer sheath (see abstract, [0003] – [0005], [0039], and [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the germicidal irradiation means of the catheter disinfecting system of Kerr and Rioux in view of a further teaching of Rioux such that the germicidal irradiation means includes one or more internal radiation sources incorporated into the introducer sheath, the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen of the introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Rioux teaches that the incorporation of a germicidal irradiation means within the introducer sheath allows for the inactivating of microorganisms within the lumen of the introducer sheath (see abstract, [0003] – [0005], [0039], and [0046] of Rioux). The inactivation (i.e., either killing or preventing from reproducing) of microorganisms is beneficial as it would allow for the lumen of the introducer sheath and whatever else is inserted through the introducer sheath to be sterilized prior to insertion within the patient’s vasculature.
With regards to claim 3, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 2, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into the sheath body for circumferentially irradiating the lumen of the introducer sheath.
Nonetheless Rioux, which is within the analogous art of sterilizable indwelling catheters (see title and abstract), teaches (Fig. 9) wherein the one-or-more internal radiation sources (232) (see [0054]) are incorporated into the sheath body (220) for circumferentially irradiating the lumen of the introducer sheath (204, 220) (see abstract, [0003] – [0005], [0039], and [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter disinfecting system of Kerr and Rioux in view of a further teaching of Rioux such that the one-or-more internal radiation sources are incorporated into the sheath body for circumferentially irradiating the lumen of the introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Rioux teaches that the incorporation of a germicidal irradiation means within the sheath body circumferentially allows for the inactivating of microorganisms within the lumen of the introducer sheath (see abstract, [0003] – [0005], [0039], and [0046] of Rioux). The inactivation (i.e., either killing or preventing from reproducing) of microorganisms is beneficial as it would allow for the lumen of the introducer sheath and whatever else is inserted through the introducer sheath to be sterilized prior to insertion within the patient’s vasculature.
With regards to claim 7, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 2, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into the sheath hub for circumferentially irradiating the lumen of the introducer sheath.
Nonetheless Rioux, which is within the analogous art of sterilizable indwelling catheters (see title and abstract), teaches (see Figs. 4 – 5) the one-or-more internal radiation sources (230) (see [0046] “light having a wavelength of interest is introduced into the catheter tube 220 via port 224, for example, by inserting a light emitting component 230 (e.g., a light source, a light guide conveying light from a light source, etc.) into the port 224 as shown in FIG. 1C”) are incorporated into the sheath hub (204) (see [0044]) for circumferentially irradiating the lumen of the introducer sheath (204, 220) (see abstract, [0003] – [0005], [0039], and [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the one-or-more internal radiation sources of the catheter-disinfecting system of Kerr and Rioux in view of a further teaching of Rioux such that the one-or-more internal radiation sources are incorporated into the sheath hub for circumferentially irradiating the lumen of the introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Rioux teaches that the incorporation of one-or-more internal radiation sources within the sheath hub allows for the inactivating of microorganisms within the lumen of the introducer sheath (see abstract, [0003] – [0005], [0039], and [0046] of Rioux). The inactivation (i.e., either killing or preventing from reproducing) of microorganisms is beneficial as it would allow for the lumen of the introducer sheath and whatever else is inserted through the introducer sheath to be sterilized prior to insertion within the patient’s vasculature.
With regards to claim 28, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 1, however, Kerr is silent with regards to wherein the germicidal radiation is selected from broad spectrum ultraviolet ("UV")-visible ("vis") light, broad spectrum UV light, UVA light, UVB light, UVC light, blue light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof.
Nonetheless Rioux, which is within the analogous art of sterilizable indwelling catheters (see title and abstract), teaches the germicidal radiation is selected from broad spectrum ultraviolet ("UV")-visible ("vis") light, broad spectrum UV light, UVA light, UVB light, UVC light, blue light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof (see [0031], [0034] “Light sources which are capable of emanating light in the infrared, visible and/or ultraviolet spectra,” [0035], and [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the germicidal radiation of the catheter-disinfecting system of Kerr and Rioux in view of a further teaching of Rioux such that the germicidal radiation is selected from broad spectrum ultraviolet ("UV")-visible ("vis") light, broad spectrum UV light, UVA light, UVB light, UVC light, blue light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof. One of ordinary skill in the art would have been motivated to make this modification because Rioux further teaches that microorganisms, such as viruses, bacteria, fungi, protozoa, algae, and so forth can be inactivated (i.e., either killed or prevented from reproducing, e.g., by molecular rearrangement of the microorganism’s DNA) using light of various wavelengths, including ultraviolet light of various wavelengths such as ultraviolet-C (UVC) light having a wavelength of 100 to 280 nm, ultraviolet-B (UVB) light having a wavelength 280 to 320 nm, and ultraviolet-A (UVA) light having a wavelength of 320 to 400 nm (see [0031] of Rioux). Therefore a person having ordinary skill in the art would select from these desirable wavelengths to inactivate the microorganisms.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerr and Rioux as applied to claims 3 above, and further in view of Dobrinsky et al. (US 2017/0281812 A1; hereinafter referred to as “Dobrinsky”).
With regards to claim 4, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 3, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into a diffuser disposed in the sheath body for circumferentially irradiating the lumen of the introducer sheath from the diffuser of the sheath body.
Nonetheless Dobrinsky, which is within the analogous art of treatment of fluid transport conduits with ultraviolet radiation (see abstract and title), teaches (see Fig. 11A) the one-or-more internal radiation sources (30) (see [0108] “an ultraviolet radiation source 30”) are incorporated into a diffuser (112) (see [0107] “a diffusive ultraviolet reflective layer”) disposed in the sheath body (see at 132 in Fig. 11A) for circumferentially irradiating the lumen of the introducer sheath (132) (see [0107] “a light guiding layer 132”) from the diffuser of the sheath body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Rioux in view of a teaching of Dobrinsky such that the catheter-disinfecting system further includes a diffuser such that the one-or-more internal radiation sources are incorporated into a diffuser disposed in the sheath body for circumferentially irradiating the lumen of the introducer sheath from the diffuser of the sheath body. One of ordinary skill in the art would have been motivated to make this modification because Dobrinsky teaches incorporating a diffusive ultraviolet reflective layer facilitates the recycling or recirculation of the ultraviolet radiation emitted from the ultraviolet radiation sources (see [0071] of Dobrinsky). Here, the recycling or recirculation of ultraviolet rotation facilitates the effective cleaning of the internal walls of the introducer sheath (see [0105] of Dobrinsky).
The catheter-disinfecting system of Kerr and Rioux modified in view of a teaching of Dobrinsky will hereinafter be referred to as the catheter-disinfecting system of Kerr, Rioux, and Dobrinsky.
With regards to claim 5, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 3, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into the sheath body behind a diffuser for circumferentially irradiating the lumen of the introducer sheath through the diffuser of the sheath body.
Nonetheless Dobrinsky, which is within the analogous art of treatment of fluid transport conduits with ultraviolet radiation (see abstract and title), teaches (see Fig. 11A) the one-or-more internal radiation sources (30) (see [0108] “an ultraviolet radiation source 30”) are incorporated into the sheath body (see at 132 in Fig. 11A) behind a diffuser (112) (see [0107] “a diffusive ultraviolet reflective layer”) for circumferentially irradiating the lumen of the introducer sheath (132) (see [0107] “a light guiding layer 132”) through the diffuser of the sheath body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Rioux in view of a teaching of Dobrinsky such that the catheter-disinfecting system further comprises a diffuser such that the one-or-more internal radiation sources are incorporated into the sheath body behind a diffuser for circumferentially irradiating the lumen of the introducer sheath through the diffuser of the sheath body. One of ordinary skill in the art would have been motivated to make this modification because Dobrinsky teaches incorporating a diffusive ultraviolet reflective layer facilitates the recycling or recirculation of the ultraviolet radiation emitted from the ultraviolet radiation sources (see [0071] of Dobrinsky). Here, the recycling or recirculation of ultraviolet rotation facilitates the effective cleaning of the internal walls of the introducer sheath (see [0105] of Dobrinsky).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerr, Rioux, and Dobrinsky as applied to claim 4 above, and further in view of Goodrich et al. (US 2019/0290360 A1; hereinafter referred to as “Goodrich”).
With regards to claim 6, the catheter-disinfecting system of Kerr, Rioux, and Dobrinsky teaches the claimed invention of Claim 4, however, Kerr is silent with regards to wherein the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of introducer sheath.
Nonetheless Goodrich, which is within the analogous art of diffuser tips (see [0098]), teaches the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of introducer sheath (see [0098] “the diffuser tip 223 is a portion of the optical fiber 202 having radiation scattering features (e.g., topography, bumps, roughenings, dimples, etc.) that encourage and/or allow the radiation (e.g., laser light, photons, radiation) to exit the optical tip in different directions (e.g., scatter, diffuse, etc.)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the diffuser of the catheter-disinfecting system of Kerr, Rioux, and Dobrinsky in view of a teaching of Goodrich such that the diffuser further includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Goodrich teaches that incorporating dimples along the diffuser encourages the radiation to exit in different directions (see [0098] of Goodrich). By having the radiation exit in different directions the sterilization encompasses the entire lumen of the introducer sheath.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerr and Rioux as applied to Claim 1 above and in further view of King et al. (US 2007/0123825 A1; hereinafter referred to as “King”)
With regards to claim 29, the catheter-disinfecting system of Kerr and Rioux teaches the claimed invention of claim 1, however, Kerr is silent with regards to wherein the introducer sheath is splittable for removing the introducer sheath from the insertion site without having to remove the catheter from the insertion site.
Nonetheless King, which is within the analogous art of conventional tear-away or split sheath introducers (see [0004]), teaches the introducer sheath (130)(see [0004]) is splittable for removing the introducer sheath from the insertion site without having to remove the catheter from the insertion site (see [0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the introducer sheath of the disinfecting system of Kerr and Rioux in view of a teaching of King such that the introducer sheath is splittable for removing the introducer sheath from the insertion site without having to remove the catheter from the insertion site. One of ordinary skill in the art would have been motivated to make this modification because King teaches that the introducer sheath can be useful in placing the catheter within the patient especially when the catheter is larger in size (see [0005] and [0009] of King). Then after placing the catheter, the ability for the introducer sheath to split allows for it to be removed from the insertion site thereby clearing the surgery field for the physician and allowing the catheter to be easily manipulated from there.
Claim(s) 1, 2, 7 – 9, and 11 – 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerr and Muse (US 2012/0053512 A1).
With regards to claim 1, Kerr discloses (see Figs. 1 – 2) a catheter-disinfecting system (see Fig. 2), comprising:
an introducer sheath (12) (see [0038]) including:
a sheath body (22) (see [0037]) configured to be percutaneously inserted into an insertion site of a patient (see [0037] “an instrument for forming an initial pathway through a patient’s skin layer, and underlying tissue, shown as an introducer 12”); and
a sheath hub (31) coupled to a proximal portion (24) of the sheath body (see [0047]).
However, King is silent with regards to the catheter-disinfecting system further comprising:
a germicidal irradiation means for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (Figs. 1 – 3 and 5) a germicidal irradiation means (50) (see [0038]) for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath (see at 32 and 24 in Fig. 5), thereby disinfecting the catheter tube immediately before insertion into the insertion site (Here the claim language of “a germicidal irradiation means for irradiating a catheter tube of a catheter with a germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim and is to be limited by structural limitations. MPEP 2114. The Office submits that the germicidal irradiation means of Muse meets the structural limitations of the claim and is capable of irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site. Support for this capability is found within at least the Abstract and paragraphs [0014], [0038], [0042], and [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr in view of a teaching of Muse such that the catheter disinfecting system further comprises a germicidal irradiation means for irradiating a catheter tube of a catheter with germicidal radiation as the catheter tube is inserted into a lumen of the introducer sheath, thereby disinfecting the catheter tube immediately before insertion into the insertion site. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
The catheter-disinfecting system of Kerr modified in view of a teaching of Muse will hereinafter be referred to as the catheter-disinfecting system of Kerr and Muse.
With regards to claim 2, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 1, however, Kerr is silent with regards to wherein the germicidal irradiation means includes one or more internal radiation sources incorporated into the introducer sheath, the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen of the introducer sheath.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (Fig. 5) the germicidal irradiation means (50) (see [0051]) includes one or more internal radiation sources (see [0051] “a source of UV-C radiation 50”) incorporated into the introducer sheath (see Fig. 5 where the source of UV-C radiation 50 is incorporated in the sheath hub), the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen (see at 24 and 32 in Fig. 5) of the introducer sheath (see [0014], [0042] and [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the germicidal irradiation means includes one or more internal radiation sources incorporated into the introducer sheath, the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into the lumen of the introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 7, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 2, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into the sheath hub for circumferentially irradiating the lumen of the introducer sheath.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (Fig. 5) the one-or-more internal radiation sources (50) (see [0051]) are incorporated into the sheath hub (see Fig. 5 at 20) for circumferentially irradiating the lumen (see at 24 and 32 in Fig. 5) of the introducer sheath (see [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the one-or-more internal radiation sources are incorporated into the sheath hub for circumferentially irradiating the lumen of the introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 8, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 7, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into a diffuser disposed in the sheath hub for circumferentially irradiating the lumen of the introducer sheath from the diffuser of the sheath hub.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (see Fig. 5) the one-or-more internal radiation sources (50) (see [0051]) are incorporated into a diffuser (60, 70) (see [0051]) disposed in the sheath hub (see at 20 in Fig. 5) for circumferentially irradiating the lumen (see at 24, 32 in Fig. 5) of the introducer sheath (see [0051]) from the diffuser of the sheath hub.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the one-or-more internal radiation sources are incorporated into a diffuser disposed in the sheath hub for circumferentially irradiating the lumen of the introducer sheath from the diffuser of the sheath hub. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 9, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 7, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into the sheath hub behind a diffuser for circumferentially irradiating the lumen of the introducer sheath through the diffuser of the sheath hub.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (see Fig. 5) the one-or-more internal radiation sources (50)(see [0051]) are incorporated into the sheath hub (see at 20 in Fig. 5) behind a diffuser (60, 70) (see [0051]) for circumferentially irradiating the lumen (see at 24, 32 in Fig. 5) of the introducer sheath through the diffuser of the sheath hub (see [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the one-or-more internal radiation sources are incorporated into the sheath hub behind a diffuser for circumferentially irradiating the lumen of the introducer sheath through the diffuser of the sheath hub. One of ordinary skill in the art would have been motivated to make this modification because Muse further teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 11, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 1, however, Kerr is silent with regards to further comprising a sheath-hub attachment configured to removably couple to the sheath hub, the germicidal irradiation means including one or more internal radiation sources incorporated into the sheath-hub attachment, and the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into a lumen of the sheath-hub attachment.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (Figs. 1 – 3) the catheter-disinfecting system further comprising a sheath-hub attachment (10) (see [0037]) configured to removably couple to the sheath hub (see at 20 in Fig. 2 and [0037]), the germicidal irradiation means including one or more internal radiation sources (50) (see [0038]) incorporated into the sheath-hub attachment (see Fig. 2), and the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into a lumen of the sheath-hub attachment (see [0014], [0038], [0042], and [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the catheter-disinfecting system further comprising a sheath-hub attachment configured to removably couple to the sheath hub, the germicidal irradiation means including one or more internal radiation sources incorporated into the sheath-hub attachment, and the one-or-more internal radiation sources configured to both produce and emit the germicidal radiation into a lumen of the sheath-hub attachment. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 12, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 11, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into a sheath-hub-attachment body for circumferentially irradiating the lumen of the sheath-hub attachment, the lumen of the sheath-hub attachment configured to lead into the lumen of the introducer sheath when the sheath-hub attachment is coupled to the sheath hub.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches the one-or-more internal radiation sources (50) (see [0038]) are incorporated into a sheath-hub-attachment body (see at 10 in Fig. 3) for circumferentially irradiating the lumen of the sheath-hub attachment (10) (see [0037]), the lumen (19) (see [0039]) of the sheath-hub attachment configured to lead into the lumen (Fig. 3) of the introducer sheath when the sheath-hub attachment is coupled to the sheath hub (see at 20 in Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the one-or-more internal radiation sources are incorporated into a sheath-hub-attachment body for circumferentially irradiating the lumen of the sheath-hub attachment, the lumen of the sheath-hub attachment configured to lead into the lumen of the introducer sheath when the sheath-hub attachment is coupled to the sheath hub. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 13, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 12, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into a diffuser disposed in the sheath-hub-attachment body for circumferentially irradiating the lumen of the sheath-hub attachment from the diffuser of the sheath-hub attachment.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches (see Figs. 1 – 3) the one-or-more internal radiation sources (50) (see [0038]) are incorporated into a diffuser (60, 70) (see [0042] – [0043]) disposed in the sheath-hub-attachment body (see at 10 in Fig. 3) for circumferentially irradiating the lumen (19) (see [0039]) of the sheath-hub attachment (10) (see [0037]) from the diffuser of the sheath-hub attachment (see [0042] – [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Muse such that the one-or-more internal radiation sources are incorporated into a diffuser disposed in the sheath-hub-attachment body for circumferentially irradiating the lumen of the sheath-hub attachment from the diffuser of the sheath-hub attachment. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
With regards to claim 14, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 12, however, Kerr is silent with regards to wherein the one-or-more internal radiation sources are incorporated into the sheath-hub-attachment body behind a diffuser for circumferentially irradiating the lumen of the sheath-hub attachment through the diffuser of the sheath-hub attachment.
Nonetheless Muse, which is within the analogous art of UV-C antimicrobial devices for intravenous therapy (see abstract and title), teaches the one-or-more internal radiation sources (50) (see [0038]) are incorporated into the sheath-hub-attachment body (see at 10 in Fig. 3) behind a diffuser (60, 70) for circumferentially irradiating the lumen (19) (see [0039]) of the sheath-hub attachment (10) (see [0037]) through the diffuser of the sheath-hub attachment (see [0042] – [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a further teaching of Kerr and Muse in view of a further teaching of Muse such that the one-or-more internal radiation sources are incorporated into the sheath-hub-attachment body behind a diffuser for circumferentially irradiating the lumen of the sheath-hub attachment through the diffuser of the sheath-hub attachment. One of ordinary skill in the art would have been motivated to make this modification because Muse teaches that it is beneficial to expose the lumen of the introducer sheath to UV-C radiation to irradiate any pathogens located within the lumen (see [0014], [0038], and [0043] of Muse).
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerr and Muse as applied to claims 8 and 13 above, and further in view of Goodrich.
With regards to claim 10, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of claim 8, however, Kerr is silent with regards to wherein the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of introducer sheath.
Nonetheless Goodrich, which is within the analogous art of diffuser tips (see [0098]), the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of introducer sheath (see [0098] “the diffuser tip 223 is a portion of the optical fiber 202 having radiation scattering features (e.g., topography, bumps, roughenings, dimples, etc.) that encourage and/or allow the radiation (e.g., laser light, photons, radiation) to exit the optical tip in different directions (e.g., scatter, diffuse, etc.)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter-disinfecting system of Kerr and Muse in view of a teaching of Goodrich such that the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of introducer sheath. One of ordinary skill in the art would have been motivated to make this modification because Goodrich teaches that incorporating dimples along the diffuser encourages the radiation to exit in different directions (see [0098] of Goodrich). By having the radiation exit in different directions the sterilization encompasses the entire lumen of the introducer sheath.
With regards to claim 15, the catheter-disinfecting system of Kerr and Muse teaches the claimed invention of Claim 13, however, Kerr is silent with regards to wherein the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of the sheath-hub attachment.
Nonetheless Goodrich, which is within the analogous art of diffuser tips (see [0098]), teaches the diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of sheath-hub attachment (see [0098] “the diffuser tip 223 is a portion of the optical fiber 202 having radiation scattering features (e.g., topography, bumps, roughenings, dimples, etc.) that encourage and/or allow the radiation (e.g., laser light, photons, radiation) to exit the optical tip in different directions (e.g., scatter, diffuse, etc.)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the diffuser of the catheter-disinfecting system of Kerr and Muse in view of a teaching of Goodrich such that the diffuser further includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser out into the lumen of sheath-hub attachment. One of ordinary skill in the art would have been motivated to make this modification because Goodrich teaches that incorporating dimples along the diffuser encourages the radiation to exit in different directions (see [0098] of Goodrich). By having the radiation exit in different directions the sterilization encompasses the entire lumen of the introducer sheath.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following prior art is pertinent regarding ultraviolet radiation sterilization:
Eckhardt et al. (US 2003/0018373 A1), Cohen et al. (US 2015/0165185 A1), Witt et al. (US 2018/0280616 A1), Ball et al. (US 2018/0369560 A1), Sugimoto et al. (US 2020/0030473 A1), Koppen et al. (US 2022/0152243 A1), Yoon et al. (US 2023/0233716 A1), Fellner et al. (US 2024/0226352 A1), Sobue et al. (US 8,197,087 B2), and Rioux et al. (US 8,556,950 B2).
The following prior art is pertinent regarding the introducer sheath:
King et al. (US 2009/0177163 A1), King et al. (US 2012/0143138 A1), Kurth et al. (US 2015/0080851 A1), and Pohndorf et al. (US 5,441,504 A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
02/06/2026