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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/18/2025 is acknowledged.
Claims 34-35 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/2025.
Information Disclosure Statement
The information disclosure statement filed 11/28/2023 which list 6 foreign patent documents fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 17-33 and 36-48 are objected to because of the following informalities:
in line 8 of Claim 17, insert --at least one-- before “light source”;
in line 16 of Claim 17, insert --a-- before “part”;
in line 18 of Claim 17, insert --at least one-- before “emission chamber”;
in line 2 of Claim 18, insert --at least one-- before “emission chamber”;
in line 1 of Claim 22, delete “filter ,” and insert --filter,--;
in line 2 of Claim 22, insert --at least one-- before “light source”;
in line 1 of Claim 24, insert --at least one-- before “emission”;
in line 1 of Claim 25, insert --at least one-- before “emission chamber”;
in line 4 of Claim 28, insert --at least one-- before “light source”;
in line 2 of Claim 33, insert --multiple-- before “adaptors”;
in line 2 of Claim 40, insert --at least one-- before “light source”;
in line 1 of Claim 41, insert --at least one-- before “emission”;
in line 1 of Claim 42, insert --at least one-- before “emission chamber”;
in line 2 of Claim 48, insert --inner-- before “cavity”.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “coupling mechanism” in claim 30.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure(s) for the “coupling mechanism” appears to be a lock/locking mechanism between two pieces/portions of an adapter/housing (see Figure 9, via a locking mechanism 19).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “guide element” in claim 32.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 36 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a “use” of a system as claimed in claim 17 which is not at least one of the four categories of patent eligible subject matter (process, machine, manufacture, or composition of matter).
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 applicant regards as his invention.
Claims 17-33 and 36-48 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.
In Claim 17, it is not clear whether “at least one light emitting opening” in line 11 and “a light emitting opening” in line 12 are attempting to set forth the same or two different light emitting openings of the light guide.
In Claim 17, it is not clear whether the at least one light source would include the light receiving opening rather than “a light emitting opening of the light guide” as set forth in lines 12-13.
Claim 17 recites the limitation "the light sources" in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
In Claim 17, it is not clear to which “light emitting opening” in line 18 is attempting to point to (i.e. “at least one light emitting opening” in line 11 or “a light emitting opening” in line 12).
Claim 17 recites the limitation "the at least one light guide" in lines 18-19. There is insufficient antecedent basis for this limitation in the claim.
In Claim 17, it is not clear in last two lines of the claim whether “the light emitting opening of the at least one light guide” is “the at least one light source” (even though the claim recites that there is a separate and distinct light source and a light guide) for “the at least one emission chamber” or that the light emitting opening is merely coupled to/in/with the at least one emission chamber to provide the emitted UVC light from the at least one light source into the at least one emission chamber or that the at least one emission chamber comprises both the at least one light source as well as the light emitting opening of the light guide (in view of lines 10-13 and lines 14-15 vs lines 18-19).
In Claim 33, it is not clear what the limitation “adaptors being applied simultaneously to a same UVC light source” is attempting to set forth. In particular, it is not clear how the multiple adaptors can be “applied simultaneously to a … light source” and it is not clear whether “a UVC light source” is attempting to point to the “at least one light source for emitting UVC light” already set forth in parent claim 17 or to another/a different UVC light source.
In Claim 36, it is not clear what particular, if any, active positive step(s) the claim, specifically the limitation “use of a catheter”, is attempting to set forth to delimit how this use is actually practiced.
Claims 18-32 and 37-48 are rejected based on their dependence on a rejected claim.
Allowable Subject Matter
Claim 17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the primary reason for indication of allowable subject matter is due to inclusion of limitations that “the system comprises at least one emission chamber, comprising at least one of the light sources; wherein the at least one emission chamber forms part of the outer surface of the adapter and is arranged around the catheter exit opening; where the at least one light emitting opening of the light guide is provided as the at least one light source for the at least one emission chamber”. While prior art such as Eckhardt (20030018373) discloses a system (figs 7A-7C) for disinfecting skin tissue (figs 7A-7C; 5) around catheters (figs 7A-7C; 15; see also 11), the system (figs 7A-7C) comprising an adaptor (figs 7A-7C; 17), wherein the adaptor (figs 7A-7C; 17) defines a catheter entry opening (figs 7A-7C; entry of 40) for entry of a catheter (figs 7A-7C; 15) into the adaptor (figs 7A-7C; 17) and a catheter exit opening (figs 7A-7C; exit of 40) for exit of the catheter (figs 7A-7C; 15) from the adaptor (figs 7A-7C; 17), wherein the adaptor (figs 7A-7C; 17) comprises an outer surface (figs 7A-7C; outer surface of 41) and an inner surface (figs 7A-7C; inner surface of 41) which defines an inner cavity (figs 7A-7C; inner cavity of 40) for receiving at least a section of the catheter (figs 7A-7C; 12), wherein the inner cavity (figs 7A-7C; inner cavity of 40) extends from the catheter entry opening (figs 7A-7C; entry of 40) to the catheter exit opening (figs 7A-7C; exit of 40); wherein the system (figs 7A-7C) further comprises at least one light source (figs 7A-7C; 7) for emitting UVC light (see for ex. [0032]), wherein the at least one light source (figs 7A-7C; 7) is arranged such that the UVC light is emitted away from (figs 7A-7C; see 38) and optionally within the adaptor (figs 7A-7C; 17); and wherein the system further comprises at least one emission chamber (9) comprising the at least one light source (7), Eckhardt (‘373) does not specifically teach that “the system further comprises a light guide, which is configured for guiding UVC light from a light receiving opening of the light guide to at least one light emitting opening of the light guide, wherein the at least one light source includes a light emitting opening of the light guide” or that “the at least one emission chamber forms part of the outer surface of the adaptor and is arranged around the catheter exit opening” nor that “the emission chamber comprises the light emitting opening of the at least one light guide as the at least one light source”. While prior art of Eltorai (20190168023) discloses that a system comprising a light guide (26) configured for guiding UVC light from a light receiving opening of the light guide to at least one light emitting opening of the light guide that is utilized between at least one light source (28) and a catheter (12) wherein the light guide (26) is directed connected/positioned/incorporated with the catheter made with a UV transparent wall to emit UVC light to a patient’s skin, Eltorai (‘023) does not specifically disclose an adaptor or “at least one emission chamber [that] forms part of the outer surface of the adaptor and is arranged around the catheter exit opening” nor that “the at least one emission chamber comprises the light emitting opening of the at least one light guide as the at least one light source”. In addition, while prior art of Motley (20200324078) discloses a system for disinfecting skin tissue around catheters (see Figure 4), the system comprising an adaptor (402), wherein the adaptor (402) defines a catheter entry opening (i.e. one end of 402 such as the opening opposite the opening annotated as 403) for entry of a catheter into the adaptor (402) and a catheter exit opening (i.e. the other end of 402 such as the opening annotated as 403) for exit of the catheter from the adaptor (402), wherein the adaptor (402) comprises an outer surface (i.e. surface pointed to by 402) and an inner surface (i.e. surface opposite to that pointed to by 402) which defines an inner cavity (403) for receiving at least a section of the catheter (see Figure 4, p. [0047] – last 4 lines), wherein the inner cavity (403) extends from the catheter entry opening (i.e. one end of 402 such as the opening opposite the opening annotated as 403) to the catheter exit opening (i.e. the other end of 402 such as the opening annotated as 403) (see Figure 4, p. [0047] – last 4 lines); wherein the system further comprises at least one light source (i.e. LED light source at one end of 404) for emitting UVC light (see entire document, particularly p. 3 [0042] – lines 2-4, p. 4 [0047] - 5th line from the bottom), wherein the at least one light source (i.e. LED light source at one end of 404 – see p. 4 [0047] - 5th line from the bottom) is arranged such that the UV light is emitted away from and optionally within the adaptor (402) (see Figure 4); wherein the system further comprises a light guide (404), which is configured for guiding UV light from a light receiving opening (i.e. at the end where the at least one light source is located) of the light guide (404) to at least one light emitting opening (i.e. end of 404 attached to 401) of the light guide (404), wherein the at least one light source (i.e. LED light source at one end of 404 – see p. 4 [0047] - 5th line from the bottom) includes the light emitting opening (i.e. end of 404 attached to 401) of the light guide (404); wherein the at least one emission chamber (401) forms a part of the outer surface (i.e. surface pointed to by 402) of the adaptor (402) and is arranged around the catheter exit opening (i.e. the other end of 402 such as the opening annotated as 403); wherein the at least one emission chamber (401) comprises the light emitting opening (i.e. end of 404 attached to 401) of the light guide (404) as the at least one light source (see Figure 4), Motley (‘078) does not appear to specifically teach that the at least one emission chamber (401) comprises the at least one light source (i.e. LED light source at one end of 404 – see p. 4 [0047] - 5th line from the bottom). It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a system comprised of components in the configuration as set forth in the claims, particularly “a light guide, which is configured for guiding UVC light from a light receiving opening of the light guide to at least one light emitting opening of the light guide, wherein the at least one light source includes a light emitting opening of the light guide” and the at least one emission chamber that “forms part of the outer surface of the adaptor and is arranged around the catheter exit opening” and “the emission chamber comprises the light emitting opening of the at least one light guide as the at least one light source”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: WO2021073730 (an adaptor for an orthopedic pin or wire comprised of an UVC light source), 20160082281 (a light delivery assembly/system in the form of an emission chamber in the shape of a ring), WO2014120620 (an adapter for a catheter comprising a UV light source), 20220226669 (a medical instrument with an adapter having a light guide incorporated), 20100222852 (a light guide UV dispensing/application tool), 20220249808 (an adapter/collar that includes LEDs to treat an insertion site ).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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