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 1-4, 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nisnevitch et al. (U.S. Publication No. 2016/0205925.
Nisnevitch discloses a method of disinfection of a medical device (paragraphs 272-274), the method comprising:
Providing a medical device (paragraphs 272-274), wherein the medical device comprises a body and a photosensitizer integrated with the body (paragraphs 33-42; 269, 272 and 279); and
Administering to the photosensitizer integrated with the body of the medical device a light dose in a range of 0.5 J/cm2 to 320 J/cm2 (paragraph 235), for a duration between 1 second and 1 hour (paragraph 234).
Concerning claims 2-4, Nisnevitch also discloses integrating the photosensitizer with the body of the medical device by compounding the photosensitizer with a base resin (paragraphs 5-7, 19-26 and 276-279); and/or
Applying a coating on a surface of the body, wherein the photosensitizer is disposed within the coating (paragraphs 266-269 & 272).
Regarding claim 6, Nisnevitch further discloses that the medical device comprises a base resin, wherein integrating the photosensitizer with the body of the medical device comprises imbibing the photosensitizer into the base resin (paragraphs 5-7, 19-26, 33-42 and 276-279).
With respect to claim 9, the reference also discloses that the medical device comprises another photosensitizer integrated with the body (paragraphs 29, 55 and 124), further comprising administering to the another photosensitizer integrated with the body of the medical device the light dose or another light dose in the range of 0.5 J/cm2 to 320 J/cm2 (paragraph 235), for the duration between 1 second and 1 hour (paragraph 234).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nisnevitch et al. (U.S. Publication No. 2016/0205925) in view of Rioux et al. (U.S. Publication No. 2008/0051736).
Nisnevitch is relied upon as set forth above. While Nisnevitch continues to disclose that the medical device comprises a catheter (paragraph 274), wherein integrating the photosensitizer with the body of the medical device comprises co-extruding the catheter with the photosensitizer and another material (paragraphs 37-42 and 164-173); the reference does not appear to disclose that the medical device comprises a catheter adapter, wherein the catheter extends distally from the catheter adapter. Rioux discloses a method of disinfection of a medical device (Figures 1 & 2), wherein the medical device comprises a catheter body (220) that is integrated/coated with a photosensitizer (paragraphs 41 & 42), wherein a light is administered to the catheter integrated with the photosensitizer to activate said photosensitizer for disinfection (paragraphs 41 and 42; Abstract). The reference continues to disclose that the medical device comprises a catheter adapter (204), wherein the catheter (220) extends distally from the catheter adapter (204) in order to provide a site that easily and accessibly allows transport of fluids and/or light sources through the catheter (paragraphs 44-46). Thus, 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 medical device of Nisnevitch with a catheter adapter, wherein the catheter extends distally from the catheter adapter in order to provide a site that easily and accessibly allows transport of fluids and/or light sources through the catheter as exemplified by Rioux.
Thus, claim 5 is not patentable over Nisnevitch in view of Rioux.
Claims 7, 8, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nisnevitch et al. (U.S. Publication No. 2016/0205925) in view of Hammad et al. (U.S. Publication No. 2021/0338863)
Concerning claims 7, 8, 11 and 12, Nisnevitch is relied upon as set forth above. Nisnevitch does not appear to disclose placing the medical device in a chamber having a first side, a second side opposite the first side, and a top extending between the first side and the second side, wherein the first side and the second side each comprise a mirror, wherein a first light source disposed on the top of the chamber emits the light dose for the duration to activate the photosensitizer and a second light source disposed on the top of the chamber emits the light dose to activate the another photosensitizer. Further, Nisnevitch does not appear to disclose any of the specifics of the lighting device at all to administer the light dose to the medical device integrated with the photosensitizer. Hammad discloses a method of disinfecting a medical device by applying a light dose to said device (Abstract; paragraph 21). The reference continues to disclose placing the medical device in a chamber having a first side (166), a second side (168) opposite the first side (166), and a top (106) extending between the first side (166) and the second side (168), wherein the first side and the second side each comprise a mirror (paragraphs 33, 34, 37 & 42) , wherein a first light source (i.e., one of the LEDs of the set) disposed on the top (106) of the chamber emits the light dose for a duration to activate disinfection and a second light source (another of the LEDs of the set) disposed on the top (106) of the chamber emits the light dose to activate the disinfection (paragraph 27; Figure 4) in order to fully encapsulate the medical item with disinfecting light (Figures 1-6; paragraphs 6-9). 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 place the medical device of Nisnevitch in a chamber having a first side, a second side opposite the first side, and a top extending between the first side and the second side, wherein the first side and the second side each comprise a mirror, wherein a first light source disposed on the top of the chamber emits the light dose for the duration to activate the photosensitizer and a second light source disposed on the top of the chamber emits the light dose to activate the another photosensitizer in order to fully encapsulate the medical item with the light to ensure all sides and surface of said medical item is exposed to said light as exemplified by Hammad.
Therefore, claims 7, 8, 11 and 12 are not patentable over Nisnevitch in view of Hammad.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nisnevitch et al. (U.S. Publication No. 2016/0205925).
Nisnevitch is relied upon as set forth above. While Nisnevitch discloses administering to the another photosensitizer integrated with the body of the medical device the light dose (paragraphs 29, 55, 124, 234 & 235); the reference does not disclose that the light dose is administered to the another photosensitizer at a different time than administering the light dose to the first photosensitizer. Nisnevitch does disclose however that the light dose is administered to the first and second photosensitizers in cycles, wherein each cycle is administered with the claimed dosage and duration (paragraphs 234 and 235). Thus, a repetition of the disclosed cycle in Nisnevitch will meet the limitations of administering to the another photosensitizer the light dose at a different time than administering to the first photosensitizer integrated within the body of the medical device the light dose as broadly defined. In as much, The Manual of Patent Examining Procedures discloses that in In re Harza, 274, F.2d 669, 124 USPQ 378 (CCPA 1960), a mere duplication of parts for a multiplied effect has no patentable significance unless a new and unexpected result is produced (See MPEP 2144.04). Similarly, the duplication or repeating of administering the light dose cycle to the photosensitizers in Nisnevitch has no patentable significance unless a new and unexpected result is produced. As such, claim 10 does not create a patentable distinction over the reference of Nisnevitch.
Therefore, claim 10 is not patentable over Nisnevitch 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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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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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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