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 .
Response to Arguments
Applicant’s arguments with respect to the 102 rejection of claims 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s amendments have necessitated a new grounds of rejection; see new 103 rejections, below.
Election/Restrictions
Claims 26-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/22/2025.
New claim 26 requires that the plurality of light emitting elements are axially staggered; this is not shown/described in the elected embodiment A (Figs. 1-7), but instead is shown in unelected embodiment B (Fig. 8).
New claims 27 and 28 require a fiber optic line formed within the wall; this is not shown/described in the elected embodiment A (Figs. 1-7), but instead is shown in unelected embodiments C, D, E and F (Figs. 9-16).
Therefore, claims 26-28 are withdrawn from consideration, leaving claims 1-5, 21-25 and 29-35 pending examination.
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 32-35 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.
Independent claim 31 makes it clear, specifically with the language “at least one of”, that the position of the light emitting elements, i.e. either within the wall or within the internal rod, are optional/alternatives, i.e. both are not required. Dependent claims 32-25 serve to further limit these optional limitations, i.e. position within the wall or rod, however it’s not clear if these dependent claims first require a specific selection to be made regarding the position, i.e. within the wall or rod, and then further limiting this selection OR if these are merely further limiting an optional limitations, which would make these limitations optional themselves. Explained differently, if claim 34 was rolled up into the independent claim, would the position of the light emitting elements have to be within the rod, or is this still just an alternative option to the wall?
For examination purposes, the examiner considers these limitations to further limit an optional limitation and therefore be optional themselves. Therefore, if the prior art teaches light emitting elements positioned in the wall, then dependent claims 34-35 (which further limit the unselected option of a rod) are not required.
If it’s applicant’s intention that these dependent claims are not optional, then applicant should amend to make that clear by reciting 1. A specific option/condition (positioned within the wall or rod) is true and 2. Further limit the selected option. For example, claim 34 should read “wherein the plurality of light emitting elements are within the internal rod and the plurality of light emitting elements are axially spaced apart within the internal rod, between the first end and the second end of the elongated shaft.”
MPEP 2173.03 states “For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate. Examiners, however, are cautioned against confusing claim breadth with claim indefiniteness.”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0121947 to Genier further in view of US 2019/0168023 to Eltoria OR US 2016/0059031 to Wescott et al.
[Claims 1 and 22] Genier discloses a system (100, Figs 1 and 2) of providing therapeutic light from a lighted catheter within a biological fluid passage (at least Pars 0046 and 0059-64), comprising:
a catheter (catheter 110) including an elongated shaft (catheter wall 112) having a first end and a second end positioned opposite the first end, the elongated shaft including:
a wall (catheter wall 112) extending between the first end and the second end and including an inner surface (fluid facing surface 114) and an outer surface formed opposite the inner surface (outer facing surface 116)
a lumen extending substantially between the first end and the second end therein (luminal fluid pathway 120; Par 0039) , the lumen at least partially defined by the inner surface of the wall (“The catheter wall 112 comprises a fluid facing surface 114 that confines the luminal fluid pathway 120”; Par 0039)
and at least one light emitting element (plurality of light emitting point sources 150; Pars 0040-41) positioned within the elongated shaft,
wherein the catheter is configured to be placed within a biological fluid passage of a human body (at least Pars 0059-64); and
a control system in electronic communication with the light emitting element, the control system configured to provide power to the at least one light emitting element such that the powered light emitting element applies a light therapy to a biological fluid passage (inherent/implicit in order to turn on/off the light sources. Genier teaches “the point source treatment fiber comprises a plurality of light emitting point sources intermittently positioned along a treatment length of the point source treatment fiber such that the plurality of light emitting point sources irradiate the catheter when the plurality of light emitting point sources emit light”. In order to emit light, a controller that supplies power to the light sources is necessary/inherent; see also Pars 0046).
While Genier explicitly teaches that the point source treatment fiber (140) which includes the plurality of light emitting elements (150) is coupled to the inner wall (“At least a portion of the point source treatment fiber 140 may contact the fluid facing surface 114, for example, coupled to the fluid facing surface 114 of the catheter wall 112” Par 0040; see also Par 0046) or coupled to the outer wall (Par 0049), but fails to explicitly teach that the light sources are within, i.e. embedded in or integral with, the wall. However, in the same field of endeavor, either Eltoria (Fig. 3E) or Wescott (Fig. 1) show a light therapy catheter with light sources embedded within the catheter wall. Specifically, Eltoria (Fig. 3E) clearly shows a light emitting element (26) embedded within the catheter wall that emits light towards the central/middle fluid lumen; see also Par 0080. Similarly, Wescott (Fig. 1) shows light emitting elements (104) embedded within the catheter wall (Pars 0011 and 0032). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Genier, which only teaches that the light sources are “coupled to” the wall, to instead be positioned within, i.e. embedded or integral with, the wall, as taught by either Eltoria or Wescott, as a known configuration for similar light therapy catheters.
[Claim 2] Genier fails to explicitly a control system that applies light therapy at predetermined time intervals. However, in the same field of endeavor, Eltoria discloses a similar light therapy catheter including a control system that applies light therapy at predetermined time intervals (Par 0075). Therefore, it would have been obvious to one of ordinary skill in the art to modify Genier to include a controller that applies light therapy at predetermined time intervals, as taught by Eltoria, as this is a known/common function in similar light therapy catheters to effectively halt, inhibit or reduce microbial or fungal growth within the catheter (Abstract of Eltoria and Pars 0041 and 0046 of Genier)
[Claims 3-4] Genier discloses light emitting elements that emit red light at 650 nm and near-infrared light at 860 nm, 870 nm or 880 nm (Par 0041)
[Claim 5] Inherently/implicitly every light source/light therapy has a predetermined intensity, i.e. brightness.
[Claims 23-24] As shown in Fig. 2 of Genier, the light emitting elements (150) are circumferentially spaced apart from each other and are radially aligned (“encircle the catheter wall” Par 0049)
[Claim 25] Genier shows both circumferentially spaced apart, radially aligned light sources (150, Fig. 2) and axially spaced apart light sources (150, Fig. 1), but it’s not clear if these two different configurations/positioning of light sources exist in the same/single embodiment. Therefore, the examiner contends that such a combination is obvious, in order to effectively target different locations on/in the catheter, as taught by Genier. Additionally or alternatively, Wescott supports this combination by showing both circumferentially spaced apart and axially spaced apart light sources. Therefore, making it clear that the positioning/location of the light sources is an obvious design/engineering choice to effectively apply light to the desired locations of the catheter.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Genier and Eltoria/Wescott as applied to claim 1 above, and further in view of US 2021/0378740 to Chu.
Genier and Eltoria/Wescott are discussed above, but fail to explicitly disclose a second lumen that protrudes from the inner surface of the catheter wall, adjacent to and extending through the lumen. First, it is emphasized that “balloon inflation” lumen does not require a balloon or inflation, as this is solely functional language/intended use, all that is required is a second lumen that protrude from the inner surface of the catheter wall into the central lumen (see applicant’s lumen 205 in Fig. 2A). Additionally or alternatively, Genier discloses a balloon catheter (Figs. 13-15; Pars 0064-66), which seemingly inherently require an inflation lumen in order to inflate/operate, but the reference is silent to the position/location of such a lumen. However, in the same field of endeavor, specifically light treatment catheters, Chu discloses a catheter (100) that includes a catheter wall (103) that defines an inner/central lumen (110) and a second lumen (105) defined by wall (106) that protrudes from the wall (103) into central lumen (110). Therefore, it would have been obvious to modify the catheter of Genier and Eltoria/Wescott to include a secondary lumen that protrudes into the inner/central lumen, as taught by Chu, as this is a known configuration for similar laser treatment catheters to allow for additional tools to be inserted, suction, irrigation and/or inflation of balloon, as is readily understood in the art. It is emphasized that the specific function of the lumen is immaterial to the patentability of the claim, and it would be obvious to add this protruding second lumen of Chu, as a known configuration in similar laser treatment catheters. For example, when considering Genier it would be obvious to make such a secondary lumen an inflation lumen, as Genier explicitly teaches a balloon, and therefore it would be necessary/obvious to provide a lumen to inflate the balloon.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Genier and Eltoria/Wescott as applied to claim 1 above, and further in view of US 2021/0378740 to Chu.
Genier and Eltoria/Wescott are discussed above, but fail to explicitly disclose an elongated shaft including a protrusion extending radially inward from the inner surface of the wall into the lumen wherein the light emitting element is formed integrally within the protrusion. However, in the same field of endeavor, specifically light treatment catheters, Chu discloses various known options/embodiments (Figs. 11-13) for incorporating a light emitting device (64A-D) into a tube/elongated shaft/catheter. Both Figs. 12 and 13 show a protrusion extending radially inward from the inner surface of the wall into a lumen. In terms of Fig. 12, this is considered a protrusion integrally formed with the light emitting device. In terms of Fig. 13, it would be obvious to make these two elements, i.e. protrusion/conduit (66) and light emitting element (64), integral as an obvious design/engineering choice; MPEP 2144.04. Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Genier and Eltoria/Wescott with the protrusion taught by Chu, as a known configuration/design within laser treatment catheters to hold/contain/secure the light emitting elements within the central/inner lumen of a catheter/tube.
Claims 30-35 are rejected under 35 U.S.C. 103 as being unpatentable over Genier and Eltoria/Wescott as applied to claim 1 above, and further in view of US 2016/0213945 to Burwell.
[Claim 30] Genier and Eltoria/Wescott are discussed above, but fail to explicitly disclose a catheter with an internal rod. However, in the same field of endeavor, specifically light treatment catheters, Burwell discloses a similar catheter (Figs. 1-3) including a catheter wall (catheter body 4) that defines an inner lumen (18) and an internal rod (guidewire; “Lumen 18 has a diameter sufficient to accommodate a guidewire and extends between distal end 6 and proximal end 8 of the catheter, passing through each portion of light-generating apparatus 1” Par 0059; see also Par 0091). Therefore, it would have been obvious to one of ordinary skill in the art to modify Genier and Eltoria/Wescott to include the internal rod/guidewire taught by Burwell, as this is a known/common element used within the central lumen of a catheter in order to place the catheter in the desired location within the body, as taught by Burwell.
[Claim 31] This claim is merely the combination of claims 1, 22 and 30, all of which are discussed above. It is emphasized that this claim does not require the plurality of light emitting elements to be within the rod. As discussed above, Genier and Eltoria/Wescott teach/suggest the plurality of light elements within the wall, as claimed.
[Claims 32-33] See explanation for claims 23-25, above.
[Claims 34 and 35] As made clear in the explanation of the 112b rejection, these are optional limitations as they merely serve to further limit an optional/alternative limitation in the independent claim. MPEP 2143.02 states “language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation”
Claim 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0121947 to Genier in view of US 2016/0213945 to Burwell.
[Claim 31] Genier discloses a system (100, Figs 1 and 2) of providing therapeutic light from a lighted catheter within a biological fluid passage (at least Pars 0046 and 0059-64), comprising:
a catheter (catheter 110) including an elongated shaft (catheter wall 112) having a first end and a second end positioned opposite the first end, the elongated shaft including:
a wall (catheter wall 112) extending between the first end and the second end and including an inner surface (fluid facing surface 114) and an outer surface formed opposite the inner surface (outer facing surface 116)
a lumen extending substantially between the first end and the second end therein (luminal fluid pathway 120; Par 0039) , the lumen at least partially defined by the inner surface of the wall (“The catheter wall 112 comprises a fluid facing surface 114 that confines the luminal fluid pathway 120”; Par 0039)
an internal rod (guidewire 140; Par 0041) extending axially through the lumen, the internal rod surrounded by the wall (“Further, at least a portion of the point source treatment fiber 140 may be positioned within the luminal fluid pathway 120 without contacting the fluid facing surface 114 of the catheter wall 112” Par 0040)
and a plurality of light emitting elements (plurality of light emitting point sources 150; Pars 0040-41) positioned on/within the rod (The point source treatment fiber 140 may comprise a guide wire and the plurality of diodes may be intermittently positioned along the guide wire, for example, intermittently coupled to the guide wire),
wherein the catheter is configured to be placed within a biological fluid passage of a human body (at least Pars 0059-64); and
a control system in electronic communication with the light emitting element, the control system configured to provide power to the at least one light emitting element such that the powered light emitting element applies a light therapy to a biological fluid passage (inherent/implicit in order to turn on/off the light sources. Genier teaches “the point source treatment fiber comprises a plurality of light emitting point sources intermittently positioned along a treatment length of the point source treatment fiber such that the plurality of light emitting point sources irradiate the catheter when the plurality of light emitting point sources emit light”. In order to emit light, a controller that supplies power to the light sources is necessary/inherent; see also Par 0046).
While Genier discloses that the light sources (150) are “coupled to” the internal rod (140), it’s not entirely clear if this means they are “within” the rod or just located on a surface of the rod. However, if it is determined that “coupled to” means that the light sources are only on the surface of the rod and not within the rod, then this modification amounts to merely making two separate components, i.e. rod and light sources, integral which has long been held obvious; see MPEP 2144.04. Therefore, it would have been obvious to modify the guidewire/rod (140) taught by Genier to be integrally formed with the light sources (instead of just being “coupled to”), as an obvious design/engineering choice. To further support this position, Burwell discloses a similar light therapy catheter including a guidewire having integral light emitting devices (Figs. 12A-D; Pars 0089-91). Therefore, it would have been obvious to modify the rod and light sources taught by Genier, to be integrally constructed, as taught by Burwell, as a known configuration for similar light emitting guidewires.
[Claims 32-33] As made clear in the explanation of the 112b rejection, these are optional limitations as they merely serve to further limit an optional/alternative limitation in the independent claim. MPEP 2143.02 states “language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation”
[Claim 34] As shown in Fig. 1, the light sources (150) are axially spaced apart along internal rod (140).
[Claim 35] The examiner considers this a duplication of parts. Specifically, Genier discloses that the diodes may be intermittently positioned along the internal rod (guidewire 140), but is silent as to whether this encompasses circumferentially spaced light sources, i.e. light sources on different sides, e.g. top, bottom, left, right, etc., of the guidewire. The examiner contends that such a duplication is obvious in order to effectively “irradiate the tissue surrounding the internal length 124 of the catheter 110 and irradiate fluid traversing the luminal fluid pathway 120, and/or a percutaneous lesion near the catheter 110, for example, to disinfect the catheter 110, fluid traversing the catheter 110, and/or tissue surrounding the catheter 110.” (Par 0046). Specifically, the location/position of the light sources is chosen in order to provide the desired effect at the desired locations within the fluid, catheter and/or tissue. Additionally or alternatively, see Figs. 12A-D of Burwell, which shows the claimed position of light sources, and such a configuration would be obvious in view of Burwell.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796