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 .
Claim Interpretation
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.
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.
Claims 1-4, 6-10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Enwemeka et al. (U.S. Publication No. 2020/0222718).
Enwemeka discloses a reusable light-activated sterilization system comprising:
A material (150/250) having layers of graphene (paragraph 227);
A light emitting source (140/240) of near infrared (NIR) radiation (paragraphs 80, 93-95 and 214); and
A waveguide (numeral 120/280; paragraphs 219-222 and 254-256);
Wherein the light emitting source emits radiation in the range of 650-950 nm (paragraph 80) with an intensity of 1-330 mW/cm2 (paragraph 81) and wherein said waveguide (120/280) is affixed with the material having layers of graphene (paragraphs 259 and 260). While Enwemeka discloses that the material (150/250) is an anode material (paragraphs 223-227) directly coupled to the waveguide (120/280) as shown in Figures 29 & 30; the reference does not appear to disclose that said waveguide (120/280) is coated with the anode material. Nonetheless, Enwemeka specifically discloses that a cathode material (numeral 260) is coated on thereon in order to successfully affix an electrically conductive layer within the system to a substrate. Because Enwemeka discloses affixing an electrically conductive material (150) having layers of graphene (paragraph 227) to a waveguide substrate (120) as shown in Figure 29, and discloses the utilization of coating an electrically conductive material (222) to a substrate (220); then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to coat the electrically conductive material (150) having layers of graphene to the substrate waveguide (120) as shown in Figure 29 of Enwemeka because Enwemeka discloses in an alternate configuration (Figure 30) that coating is a successful method for properly affixing an electrically conductive material to a substrate in paragraph 262.
Therefore, claim 1 is not patentable over Enwemeka.
Concerning claim 2, Enwemeka continues to disclose that the light emitting source of NIR radiation is a LED (paragraphs 228-252).
With respect to claim 3, the reference also discloses that the light activated sterilization results from the presence of the layers of graphene (paragraphs 209-227).
Regarding claims 4, 10 and 12, Enwemeka discloses that the material having layers of graphene has up to 800 layers of graphene, or is a few-layer graphene film, or is a multi-layer graphene film (paragraph 227).
Concerning claim 6, Enwemeka further discloses that the waveguide (120/280) is connected to the light emitting source (140/240) as shown in Figures 29 & 30.
With respect to claim 7, Enwemeka also discloses that the light emitting source emits radiation in the range of 750-850 nm (paragraph 80).
Concerning claim 8, Enwemeka continues to disclose that the system is capable of operating such that the radiation is continuously emitted for 1-60 minutes (paragraphs 98 and 257).
Regarding claim 9, the reference further discloses that the system is capable of operating such that the light emitting source emits radiation with an intensity of 10-250 mW/cm2 (paragraph 81).
With respect to claim 13, Enwemeka also discloses that the material having layers of graphene has a thickness of 0.3 nm to 100 µm (paragraph 225).
Concerning claim 14, Enwemeka further discloses a medical device comprising the reusable light activated sterilization system according to claim 1 (Figures 51-54; paragraphs 93-97).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Enwemeka et al. (U.S. Publication No. 2020/0222718) in view of Nel et al. (U.S. Publication No. 2020/0270134)
Enwemeka is relied upon as set forth above. While Enwemeka discloses that the material is a few-layer graphene film (paragraph 227), the reference does not appear to disclose that the film is graphene oxide. Nel discloses coatings for medical devices (paragraphs 3, 137 and 138) that act as an electrical conductor (paragraphs 153 and 154) and antibacterial (paragraph 3). The reference continues to disclose that the coating is a graphene oxide film because graphene oxide is not only an excellent conductor (paragraph 154), but also acts as an antibacterial as well (paragraph 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize graphene oxide as the few-layer film in Enwemeka because graphene oxide is not only an excellent conductor, but also acts as an antibacterial as well as exemplified by Nel.
Therefore, claim 11 is not patentable over Enwemeka in view of Nel.
Claims 15 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Enwemeka et al. (U.S. Publication No. 2020/0222718) in view of Barneck et al. (U.S. Publication No. 2019/0217117).
Enwemeka is relied upon as set forth above. Enwemeka does not appear to disclose that the medical device is a catheter cap and a catheter. Barneck discloses a reusable light-activated sterilization system that includes a light source (paragraph 97) connected to a power source for emitting near infrared (NIR) radiation in a range of 650-950 nm with an intensity of 1-330 mW/cm2 (paragraphs 24 and 98), and a waveguide (50/14) for said NIR radiation as shown in Figures 1-6 (paragraph 97). The reference continues to disclose that the system is a catheter and cap for said catheter in order to inactivate infectious agents in, on or around a catheter (Abstract). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the system of Enwemeka in a catheter and cap for said catheter in order to inactivate infectious agents in, on or around the catheter as exemplified by Barneck.
Thus, claims 15 & 16 are not patentable over Enwemeka in view of Barneck.
Claims 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Barneck et al. (U.S. Publication No. 2019/0217117) in view of Enwemeka et al. (U.S. Publication No. 2020/0222718).
Regarding claims 17, 19 and 20, Barneck discloses a sterilization cap for a catheter (22) comprising:
A cap body (20) delimiting a compartment (Figures 1-5);
A power source (26) housed in said compartment (paragraph 87);
A light source (paragraph 97) connected to said power source for emitting near infrared (NIR) radiation in a range of 650-950 nm with an intensity of 1-330 mW/cm2 (paragraphs 24 and 98); and
A waveguide (50/14) of said NIR radiation extending from the cap body (20) and delimiting an outer surface as shown in Figures 4-6 (paragraph 97).
Barneck does not appear to disclose that the outer surface of said waveguide comprises a material having layers of graphene. As noted above, Enwemeka discloses a reusable light-activated sterilization system that includes a light emitting source (40) of near infrared (NIR) radiation (paragraphs 80, 93-95 and 214), and a waveguide (i.e., quantum dot film coating), wherein the light emitting source (40) emits radiation in the range of 650-950 nm (paragraph 80) with an intensity of 1-330 mW/cm2 (paragraph 81). The reference continues to disclose that the outer surface of said waveguide comprises a material having up to 800 layers of graphene, or a few-layer graphene film in order to protect the light source and waveguide (paragraph 227). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the outer surface of the waveguide of Barneck with a material having up to 800 layers of graphene, or a few-layer graphene film in order to protect the light source and waveguide as exemplified by Enwemeka.
Thus, claims 17, 19 and 20 are not patentable over Barneck in view of Enwemeka (herein referred to as modified Barneck).
With respect to claim 18, while Enwemeka does not appear to disclose that the waveguide is at least partially coated with the material having layers of graphene, as the reference does not disclose how the material is affixed to said waveguide; Enwemeka does disclose that the material (150/250) is an anode material (paragraphs 223-227) directly coupled to the waveguide (120/280) as shown in Figures 29 & 30. Furthermore, Enwemeka specifically discloses that a cathode material (numeral 260) is coated on thereon in order to successfully affix an electrically conductive layer within the system to another component. Because Enwemeka discloses affixing an electrically conductive material (150) having layers of graphene (paragraph 227) to a waveguide substrate (120) as shown in Figure 29, and discloses the utilization of coating an electrically conductive material (222) to a substrate (220); then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to coat the electrically conductive material (150) having layers of graphene to the substrate waveguide (120) as shown in Figure 29 of Enwemeka because Enwemeka discloses in an alternate configuration (Figure 30) that coating is a successful method for properly affixing an electrically conductive material to a waveguide substrate in paragraph 262. Therefore, the modification of Barneck with Enwemeka would also partially coat the material having layers of graphene to the waveguide.
As such, the limitations of claim 18 are meet by Barneck in view of Enwemeka as well. Thus, claim 18 is also not patentable over Barneck in view of Enwemeka.
Concerning claim 21, the medical device of Barneck is fully capable of functioning with a hemodialysis or chemotherapy catheter (Figures 1-9). Note, the catheter is not positively recited in claim 16.
Thus, claim 21 is not patentable over Barneck in view of Enwemeka as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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/KEVIN JOYNER/ Primary Examiner, Art Unit 1799