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 § 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.
Claims 1-3, 4, 10 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hutchens (U.S. Publication No. 2016/0354503).
Concerning claims 1, 4 and 11, Hutchens discloses a method and disinfection device for disinfection of medical equipment and/or a section thereof (Abstract), the method and disinfection device comprising:
A housing comprising a disinfection chamber (108/708/808), the disinfection chamber being adapted to at least partly enclose a section of a medical equipment (Figures 1-4, 7-9, 15, 16 and 20);
At least one ultraviolet light emitting diode (UV-LED; numeral 118) configured to emit UV-light in the wavelength range of 100-400 nm directly into the disinfection chamber (paragraphs 33, 46, 49, 91, 101 and 113);
A control unit (120) configured to control the UV-LED (paragraphs 9, 12, 24 and 25); and
An integrated power source (122) connected to the UV-LED (paragraphs 8 and 25);
Wherein the control unit (120) is further configured to run a plurality of disinfection cycles, each cycle comprising an on-period of UV-light emission from the UV-LED and an off-period of no UV-light emission from the UV-LED (paragraphs 71-78); and wherein the method discloses:
Placing the disinfection device in contact with at least a section of the medical equipment (Figures 1-4, 7-9, 15, 16 and 20), such that the disinfection device at least partly encloses the section of the medical equipment (Figures 3, 4, 9, 15, 16 and 20); and
Prompting the control unit (120) comprised in the disinfection device (Figures 1 & 9) to run a plurality of disinfection cycles, each cycle comprising an on-period of UV-light emission from the UV-LED (118) and an off-period of no UV-light emission (paragraphs 71-78), wherein the UV-light emitted during the on-period is emitted directly onto the section of the medical equipment intended to be disinfected (Figures 1, 2, 7-9, 15, 16 and 20).
Regarding claims 2 & 12, Hutchens continues to disclose that the at least one disinfection cycle of the plurality of disinfection cycles comprises an on-period with a duration of at least 0.5 seconds (paragraph 88).
With respect to claims 3 & 13, Hutchens also discloses that the off-period has a duration of at least twice the duration of the on-period for each disinfection cycle of the plurality of disinfection cycles (See t3-t10 of Figure 12).
Regarding claim 10, Hutchens continues to disclose that the disinfection device has an open configuration and a closed configuration, wherein the disinfection device is in the closed configuration during use (paragraphs 72-74).
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 5, 9 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hutchens et al. (U.S. Publication No. 2016/0354503).
Concerning claims 5 and 14-17, Hutchens is relied upon as set forth above. Hutchens does not appear to disclose the total UV-dose that is emitted over a specific period of time, but does recognize that the UV-dose emitted over a specific period of time is a result effective variable based on various factors such as the type of medical equipment being disinfected in the device, distance between UV light source and the medical device, geometry of the device, number of pieces of medical equipment within the device, and possible contaminants on said device in paragraphs 11, 27, 47 and 48. As such, the Courts have held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456,105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Thus, it would have been well within the purview of one of ordinary skill in the art to provide the total UV-dose emitted by the UV-LED to at least 20.833, 41.55 or 1000 mJ/cm2 measured over a period of 30 minutes, 60 minutes or 60 days respectively, in which the plurality of disinfection cycles are ran for at least 1 hour up to 60 days in order to successfully disinfect one of more pieces of medical equipment within the device based on various factors such as the type of medical equipment being disinfected in the device, distance between the UV light source and the medical device, geometry of the device, number of pieces of medical equipment within the device, and possible contaminants on said device for a given application; as such are considered result effective variables that one of ordinary skill would optimize through routine experimentation. Only the expected results would be attained.
As such, claims 5, 16 and 17 are not patentable over Hutchens as well.
Regarding claim 9, Hutchens further does not appear to disclose that the total volume of the disinfection device being of a maximum of 0.0015 m3. However, In Gardner v. TEC Systems, Inc., 725 F .2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. Denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Because both the claimed device and the prior art device disclose disinfecting a portion of a catheter type medical device, in which the enclosures are fairly similar (particularly as shown in Figures 9, 13, 14 and 16-18 of Hutchens), then the claimed dimensions of the total volume of the disinfection device being of a maximum of 0.0015 m3 as set forth in claim 9 is not considered to be a patentable distinction from the disclosed Hutchens device (See MPEP 2144.04).
Thus, claim 9 is also rejected over Hutchens.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hutchens et al. (U.S. Publication No. 2016/0354503) in view of Koppen et al. (U.S. Publication No. 2022/0152243).
Hutchens is relied upon as set forth above. While the reference continues to disclose that the housing comprises a through hole (shown at numeral 212 in Figure 2) extending through the housing and adapted to enclose at least a section of an elongate medical equipment, and wherein the disinfection chamber forms part of the through hole (Figures 1, 2, 7-9, 15 & 20); Hutchens does not appear to disclose that the through hole extends throughout the housing. Koppen discloses a disinfection device for disinfection of medical equipment (Abstract), wherein the device includes a housing (2) with a chamber (22) and an ultraviolet light source (6) for disinfecting at least a portion of the medical equipment (paragraphs 79-86) as shown in Figures 1-7. The reference continues to disclose that the housing comprises a through hole (24) extending throughout the housing and adapted to enclose at least a section of an elongate medical equipment, wherein the disinfection chamber (22) forms part of the through hole (paragraphs 80-85). Koppen discloses that the through hole extending throughout the housing is provided in order to allow the device to be moved and placed on different portions of the medical equipment (paragraphs 80-85; Figures 1-7). 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 extend the through hole of Hutchens throughout the housing, wherein the disinfection chamber forms a part of the through hole in order to allow the device to be moved and placed on different portions of the medical equipment as exemplified by Koppen.
Thus, claim 6 is not patentable over Hutchens in view of Koppen.
With respect to claim 18, Hutchens continues to disclose that the elongate medical equipment is one of a catheter and a tube (paragraphs 22 & 24; Figures 1-4, 7, 8 and 15).
Claims 7, 8, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hutchens et al. (U.S. Publication No. 2016/0354503) in view of Swaney et al. (U.S. Publication No. 2020/0254121).
Hutchens is relied upon as set forth above. While Hutchens discloses that the device is operable as a single use device (Figures 1-4, 7-9, 15 and 20), wherein the integrated power source is a battery (paragraph 25); the reference does not appear to disclose that the battery is a primary cell battery that has enough power capacity of at least 60 days of continuous use. Swaney discloses a disinfection device for disinfection of medical equipment, wherein the device includes a housing for enclosing the medical equipment (Figures 1-6), a UV light source within the housing (paragraphs 10 and 72-75), a control unit (paragraphs 6 and 63), and an integrated power source (paragraph 63). The reference continues to disclose that the battery is a primary cell battery that has enough power capacity of at least 60 days of continuous use in order to reduce the number of times the battery may need to be replaced (paragraphs 63-66). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a primary cell battery that has enough power capacity of at least 60 days of continuous use as the battery in Hutchens in order to reduce the number of times the battery may need to be replaced as exemplified by Swaney.
Therefore, claims 7, 8, 19 and 20 are not patentable over Hutchens in view of Swaney.
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
