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 Species 5, directed to a surgical drain in the reply filed on January 7 th , 2026 is acknowledged. Claims 24-36 remain pending and are up for examination in this application. 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 § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 24-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 24 recites, “or similarly functioning form of medical grade material…” The term “ similarly ” in claim 24 is a relative term which renders the claim indefinite. The term “ similarly ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required . Regarding claim 24, the phrase "preferably" i.e., “(<10 cm and preferably <1 cm)” in line 7 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, it is unclear if the limitations in the parentheticals are claimed i.e., “ < 10 cm and preferably <1 cm”. As such, it is suggested to remove the parentheticals as well as the term “preferably”. Appropriate action is required. Claim 24 recites the limitation "the human" in line 11 . There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to “the patient”. Appropriate action is required. Note “the human” is found in the second to last line of the claim as well. Again, regarding claim 24, the phrase "preferably" i.e., “(preferably <10 cm, more preferably <1 cm)” in line 13 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, it is unclear if the limitations in the parentheticals are claimed i.e., “preferably <10 cm, more preferably <1 cm”. As such, it is suggested to remove the parentheticals as well as the term “preferably”. Appropriate action is required. Claims 25-36 are rejected as well merely due to their dependency from claim 24. Concerning claim 26, the phrase "such as" in items “c” “d” and “g” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). With respect to claim 27, the phrase "preferably" in item “c” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Concerning claim 29, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). With respect to claim 30, the phrase "more particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 31 recites, “or similarly functioning configuration…” The term “ similarly ” in claim 31 is a relative term which renders the claim indefinite. The term “ similarly ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required . Regarding claim 35, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Again, regarding claim 35, the phrase "as in” i.e., “as in an ambulance, or o n a patient” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). With respect to claim 36, the phrase "more particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Again, with respect to claim 35, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate action 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. Claims 24-27, 29 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barneck et al. (U.S. Publication No. 2016/0317832). Barneck discloses a n apparatus for maintaining disinfection or sterilization of percutaneous or indwelling medical devices configured for insertion into a patient's body (paragraphs 10-14) , comprising a drainage or delivery tube (12) or similarly functioning form of medical grade material having a proximal end at the percutaneous entry and a distal end within the patient's body (paragraph 39) , wherein the drainage or delivery tube (12) incorporates one or more fiber optic cables, optical fibers, light guides (64A-I) extending from adjacent a proximal end of the tube towards a distal end of the tube (Figures 1, 2 & 9-12) configured to direct and deliver safe antimicrobial wavelengths near field from a light source (36) to both animate and inanimate targets (paragraphs 42 & 47) to safely and efficiently disinfect the medical device and adjacent patient tissue at targeted locations while in use with an optimally efficient dosing to reduce nosocomial infections while protecting the human and environmental microbiome (paragraph 13) , and further comprising multiple fiber optic cables, optical fibers, light tubes, or light guides (64A-I; paragraphs 48 & 50) for delivery of antimicrobial wavelengths in a near field location to a specified target for optimally effective dosing allowing for shorter periods of irradiance to provide effective disinfection of target pathogens while protecting the human and environmental microbiome from dysbiosis (paragraphs 13, 47-53 and 60-63; Figures 1, 2 & 8-12) . Concerning claim 25, Barneck continues to disclose that the fiber optic cables, optical fibers, light tubes or light guides are configured with one or more optical features used to refract, diffuse, reflect, focus or direct antimicrobial light onto adjacent targeted patient tissues to aid in preventing or reducing pathogen burden in the case of an already contaminated device (paragraphs 48, 50 & 53). Regarding claim 26, Barneck also discloses an antimicrobial light source (36) safe for patient and health care worker exposure that emits blue visible light at a wavelength of 400-470 nm (paragraphs 13, 43 and 44). With respect to claim 27, Barneck also discloses that the percutaneous or indwelling medical device is capable of being any percutaneous drain which may enter any body cavity spaces, orthopedic spaces or subcutaneous spaces (Figures 1-12; paragraphs 4-7 and 10). Concerning claim 29, Barneck further discloses that the light source is an LED source of safe antimicrobial wavelengths (paragraph 13), that is stationary within a hospital room, or mobile and configured for use in an ambulatory capacity as in an ambulance, or on a patient who is mobile (paragraphs 13, 42 & 43; Figures 1 & 2). Regarding claim 30, the reference continues to disclose that the light source (36) is a light source of safe antimicrobial light, which is an LED light source emitting visible antimicrobial blue light (paragraphs 13, 42 and 43). Claims 31 and 33-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matter (U.S. Patent No. 5,855,203). It is first noted that claim 31 does not positively recite the fluid or the antimicrobial light, but merely a device configured to carry said fluid and said antimicrobial light. As such, the claim will be examined accordingly. Matter discloses a n indwelling or percutaneous medical device configured for insertion into a patient's body (column 2, lines 20-40) , comprising a tube (20) or similarly functioning configuration for fluid delivery, physiologic monitoring, or physiologic drainage is formed of medical grade material having a proximal end and a distal end (column 2, lines 20-40; Figures 1-6) , wherein an internal surface of the tube is covered at least in part with a light reflecting material (column 4, lines 23-37) , whereupon the device is configured to carry both a fluid and antimicrobial light from a light source via an optical fiber, a fiber optic cable, a light pipe or a light guide along its length, or at least in part (Figures 1-6; column 4, line 11 to column 6, line 13) . Concerning claim 33, Matter also discloses that the tube or percutaneous or indwelling medical device acts as an optical fiber, fiber optic cable, light tube or light guide to include one or more optical features that are then molded onto or into such percutaneous or indwelling medical devices to refract, diffuse, reflect, focus or direct antimicrobial light on either or both external and internal surfaces of the percutaneous or indwelling medical device or along its length (column 4, lines 23-37). With respect to claim 34, Matter also discloses that the device is capable of operating as any surgical drain that enters a body cavity or space, orthopedic spaces, or subcutaneous spaces (Figures 1-6; column 2, lines 5-51). Regarding claims 35 & 36, Matter continues to disclose that the light source is capable of being an LED light source of safe antimicrobial light wavelengths that is stationary within a hospital room, or mobile and configured for use in an ambulatory capacity as in an ambulance, or on a patient who is mobile (column 5, line 60 to column 6, line 26). 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 28 is rejected under 35 U.S.C. 103 as being unpatentable over Barneck et al. (U.S. Publication No. 2016/0317832) in view of Dacey, JR. et al. (U.S. Publication No. 2011/0152978). Barneck is relied upon as set forth above. Barneck continues to disclose that: T he percutan e ous or indwelling medical device and optical fibers, optical fibers, light tubes or light guides (64A-I) are manufactured to be co-molded or embedded into as part of the percutaneous or indwelling medical device (Figures 9-12; paragraphs 60-63) ; and That the single or multiple fiber optic cables, optical fibers, light tubes or light guides (64A-I) comprise a side-emitting device configured for diffusion and dispersion of a particular dose of light along the length and the distal end (paragraph 57) . The reference does not appear to disclose that t he fiber optic cables, optical fibers, light tubes, or light guides are manufactured to be co-molded in a helical configuration within the percutaneous or indwelling medical device . Dacey discloses an apparatus for maintaining disinfection of indwelling medical devices configured for insertion into a patient’s body (Abstract; Figures 1-3) comprising a delivery tube (102) and a source of antimicrobial light (221) configured to disinfect said delivery tube (paragraphs 165 & 166). The reference continues to disclose that light guides (202a) are manufactured to be co-molded or arranged in a helical configuration within or on the indwelling medical device in order to provide the antimicrobial light to the medical device in a configuration that provides a substantially uniform light distribution throughout the entirety of said medical device (paragraphs 143 and 144). 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 manufacture the light guides of Barneck to be co-molded in a helical configuration within the percutaneous or indwelling medical device in order to provide the antimicrobial light to the medical device in a configuration that provides a substantially uniform light distribution throughout the entirety of said medical device as exemplified by Dacey. Therefore, claim 28 is not patentable over Barneck in view of Dacey. Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Matter (U.S. Patent No. 5,855,203) in view of Barneck et al. (U.S. Publication No. 2016/0317832). Matter is relied upon as set forth above. While the reference continues to disclose that the light reflective material is at least partially reflective to far UV-C light having a wavelength of 200-230 nm, or blue light having a wavelength of 400-470 nm (column 4, lines 23-65) , and further comprising a central disinfecting light source configured to generate safe antimicrobial light which acts as a manifold to deliver antimicrobial wavelengths near field to such devices as well as to adjacent animate and inanimate targets using optical fibers, light pipes or light guides to prevent nosocomial infections or reduce contaminant burdens in various physiologic spaces (column 4, lines 23-65; column 5, line 37 to column 6, line 12); Matter does not appear to disclose that the light source is configured to generate antimicrobial blue light having a wavelength of 400-470 nm. Nonetheless, as noted above, Barneck discloses a n apparatus for maintaining disinfection or sterilization of percutaneous or indwelling medical devices configured for insertion into a patient's body (paragraphs 10-14) , comprising a drainage or delivery tube (12) or similarly functioning form of medical grade material having a proximal end at the percutaneous entry and a distal end within the patient's body (paragraph 39) , wherein the drainage or delivery tube (12) incorporates one or more fiber optic cables, optical fibers, light guides (64A-I) extending from adjacent a proximal end of the tube towards a distal end of the tube (Figures 1, 2 & 9-12) configured to direct and deliver safe antimicrobial wavelengths near field from a light source (36) to both animate and inanimate targets (paragraphs 42 & 47). The reference continues to disclose that the light source is configured to generate antimicrobial blue light having a wavelength of 400-470 nm because blue light at said wavelengths is known to kill infectious pathogens without causing damage to living cells (paragraphs 8, 13 and 43) . 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 a light source that is configured to generate antimicrobial blue light having a wavelength of 400-470 nm in Matter because blue light at said wavelengths is known to kill infectious pathogens without causing damage to living cells as exemplified by Barneck. As such, claim 32 is not patentable over Matter in view of Barneck. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KEVIN C JOYNER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2709 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8:00AM-4:30PM . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT MICHAEL MARCHESCHI can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-1374 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEVIN JOYNER/ Primary Examiner, Art Unit 1799