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
Newly submitted claims 21-33 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (claims 1 and 3-8) and III (claims 21-33) are related as product made and process of making. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the fiber opted medical infusion line of claim 1 may be made by folding a sheet of material into a tube, molding a tube, or removing the internal space from a cylinder of material to form a tube instead of through extrusion as claimed in claim 21.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-33 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 04/08/2022, 12/17/2025, and 05/26/2026 has/have been considered by the Examiner.
Status of the Claims
Claims 2 and 9-20 are cancelled. Claims 21-33 are newly added. Claims 1,3-8 and 21-33 are currently pending. Claims 1 and 3-8 are currently rejected. Claims 21-33 are currently withdrawn due to election by original presentation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 06/10/2025 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.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 2 reads “a elongate body”. This should read “an elongate body”.
Claim 8 line 2 reads “a passive wireless one line antennae”. This should read “a passive wireless one line antenna[[e]]”, since only one antenna is being claimed. Note Merriam-Webster indicates that “antennas” is usually the plural for a wire device and “antennae” is usually the plural for insect organs (https://www.merriam-webster.com/dictionary/antennae).
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “passive wireless one line antennae” (claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-2, 5, and 7 is/are rejected under 35 U.S.C. 103 as being obvious over Utz (US 20170023216 A1; hereafter Utz) in view of Griffin (US-20110038580-A1; hereafter Griffin) and further in view of Hopkins (US-20150212312-A1; hereafter Hopkins).
Regarding claim 1, Utz discloses a fiber optic medical infusion line (infusion line structure 306, fig. 3 and fig. 4, [0036]), comprising:
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a elongate body (see portion of infusion line structure 306 outlined in dotted lines in see Utz Modified Fig. 4 above; note that elongate body is separable from the fiber optic cable as noted in [0043]) that is substantially cylindrical (note that as pictured in fig. 4, the elongate body appears “substantially cylindrical”) and extends from a proximal end to a distal end (see Utz Modified Fig. 4) and the elongate body having a hollow structure (note that fluid transmission channel 304 runs through the elongate body) and an exterior surface(see Utz Modified Fig. 3 below) and an interior surface (see Utz Modified Fig. 3 below);
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a fiber optic cable (remaining portion of infusion line structure 306 not outlined by a dotted line in Utz Modified Fig. 4 above) having a proximal end and a distal end (see Utz Modified Fig. 4 above), the fiber optic cable comprising a jacket (see Utz Modified Fig. 4 and Utz Modified Fig. 3 above) and a core (light transmission channel 302; [0044] “light transmission channel (302) is implemented as an optical fiber”; see Utz Modified Fig. 4 and Utz Modified Fig. 3 above) for transmitting visible light (note core contains light transmission channel 302; [0044] “light transmission channel (302) is implemented as an optical fiber”), the fiber optic cable is engaged to the exterior surface of the elongate body (see exterior surface of elongate body engaged with the fiber optic cable in both fig. 3 and fig. 4) ([0043] The illuminating infusion line of FIG. 4 however also has an exposure (402) allowing the light transmission channel (302) to be separated from the fluid transmission channel (304)).
Utz is silent to a distal end cap engaged to the distal end of the fiber optic cable and a fiber funnel cap at the proximal end of the fiber optic cable.
Griffin, in the art optical devices using fiber optics for medical purposes [0019], teaches a distal end cap (cap member 125 and redirecting element 126, fig. 2, [0023] “a cap member 125 and a redirecting element 126 that is received within the cap member 125. The redirecting element 126 comprises a fiber optic segment 132 and a sleeve 134”) engaged to the distal end of the fiber optic cable (fiber optic 118, [0020], fig. 2 shows distal end of fiber optic cable 118 engaged with the cap 125/126, also described in [0032]), the distal end cap (125/126) having a polished surface (reflecting end 192 of fiber optic segment 132 of redirecting element 126 which is part of cap 125/126, fig. 2 and fig. 6, [0038] “reflecting end 192 of the fiber optic segment 132 and the end 194 of the sleeve 134 are cut and polished using conventional techniques, such as mechanical polishing”) to allow for reflection of the transmitting visible light ([0029] “The interior side of the beveled end surface 150 forms an optical surface that reflects or redirects the laser light signals 139 received from the delivery core fiber 136”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Utz to include a distal end cap with a polished surface, as taught by Griffin, since both references deal with fiber optic cables used in the medical field. One would have been motivated to make the modification because, as taught by Griffin, this arrangement allows for the device to reliably direct the light carried along the fiber optic cable onto a surgical site within a body.
Utz as modified is silent to a fiber funnel cap at the proximal end of the fiber optic cable
Hopkins, in the art of endoscopes, teaches a fiber funnel cap (see noted connection in Hopkins Modified Fig. 2 below) at the proximal end of the fiber optic cable (fiber optic bundle 48 and waveguide 14, fig. 2, [0026]).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Utz as modified to include the fiber funnel cap at the proximal end of the fiber optic cable of Utz, as taught by Hopkins, since both references deal with fiber optics inserted into the body. One would have been motivated to make the modification because so that the fiber optic cable is securely attached to the light source and housing to provide consistent, reliable lighting of the fiber optic cable.
Regarding claim 3, Utz as modified discloses the fiber optic medical infusion line of claim 1, as described above, including wherein the fiber funnel cap (see Hopkins Modified Fig. 2 above which indicates the fiber funnel cap) is engaged to an electronic illuminator (Hopkins: endoscopic light source 12, fig. 2, [0025] endoscopic light source 12 for providing visible light to a waveguide 14 that provides visible light to an endoscope 16).
Regarding claim 5, Utz as modified discloses the fiber optic medical infusion line of claim 1, as described above. Utz further discloses comprising a separator zone (exposure 402, fig. 4, [0043]) between the elongate body (portion of structure outlined with a dotted line in Utz Modified Fig. 4) and the fiber optic cable (remainder of structure not outlined with a dotted line in Utz Modified Fig. 4) for enabling the elongate body to be separated from the fiber optic cable ([0043] The illuminating infusion line of FIG. 4 however also has an exposure (402) allowing the light transmission channel (302) to be separated from the fluid transmission channel (304) such that a source of illumination (308) may be used to directly illuminate the light transmission channel and therefore illuminating the infusion line.).
Regarding claim 7, Utz as modified discloses the fiber optic medical infusion line of claim 1, as described above. Utz further discloses wherein the elongate body (see Utz Modified Fig. 4) is configured to allow transmission of a fluid (note fluid transmission channel 304 goes through elongate body as shown in fig. 3 and fig. 4; [0042]).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being obvious over Utz as modified and applied to claim 1 above, and further in view of Goebelbecker et al (EP 1168025 A2; hereafter Goebelbecker).
Regarding claim 4, Utz as modified discloses the fiber optic medical infusion line of claim 1, as described above.
Utz as modified is silent to wherein the fiber optic cable is a side emitting fiber optic cable.
Goebelbecker, in the art of visually distinct fiber optic cables which act as conduits for signals, teaches wherein the fiber optic cable (side-emitting optical fiber 50, fig. 2b, [0018]) is a side emitting fiber optic cable ([0018] “The fiber optic communication cable illustrated in Fig. 2b is similar to that of Fig. 2a, except that the cable jacket 70 is made entirely from translucent material 75”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fiber optic cable of Utz to include the side-emitting optical fiber 50 of Goebelbecker since both references deal with fiber optic cables. One would have been motivated to make the modification because, as noted in Goebelbecker [0018], “a pre-existing fiber optic cable may be improved by adding a side-emitting optical fiber 50 to its periphery and enclose the cable in a translucent jacket to add optically detectable characteristics.” Specifically, a PHOSITA would have been motivated to include the side-emitting optical fiber of Goebelbecker to allow a medical practitioner to visually see that the light from the light source is making it all the way along the fiber optic cable, thus showing that the device is working appropriately.
Regarding claim 6, Utz as modified discloses the fiber optic medical infusion line of claim 1, as described above.
Utz as modified is silent to wherein the jacket is composed of a transparent material, allowing light emitted by the core of the fiber optic cable to be visible through the jacket.
Goebelbecker, in the art of visually distinct fiber optic cables which act as conduits for signals, teaches wherein the jacket (cable jacket 70, fig. 2b, [0018]) is composed of a transparent material ([0018] “The fiber optic communication cable illustrated in Fig. 2b is similar to that of Fig. 2a, except that the cable jacket 70 is made entirely from translucent material 75”), allowing light emitted by the core of the fiber optic cable to be visible through the jacket ([0001] “a side-emitting optical fiber included in a transparent or translucent cable jacket in order to assist in identifying the transmission cable at any point along its length”; [0013] “The translucent jacketing material 45 is a flexible translucent insulating material, and allows the side emitting optical fiber to be observed therethrough.”)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fiber optic cable of Utz to include the side-emitting optical fiber 50 in a transparent jacket as taught by Goebelbecker since both references deal with fiber optic cables. One would have been motivated to make the modification because, as noted in Goebelbecker [0018], “a pre-existing fiber optic cable may be improved by adding a side-emitting optical fiber 50 to its periphery and enclose the cable in a translucent jacket to add optically detectable characteristics.” Specifically, a PHOSITA would have been motivated to include the side-emitting optical fiber of Goebelbecker to allow a medical practitioner to visually see that the light from the light source is making it all the way along the fiber optic cable, thus showing that the device is working appropriately.
Alternatively, Utz as modified is discloses the claimed invention except for the material being transparent rather than translucent. It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a material that was transparent, instead of only translucent, since Goebelbecker mentions the use of transparent materials as well as translucent materials, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07. One would have been motivated to make the modification because a transparent material would even better allow passage of light through the jacket than a translucent material.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being obvious over Utz as modified and applied to claim 1 above, and further in view of Twiss et al (CA 2199952 A1; hereafter Twiss) and alternatively further in view of Amin (US 20200368513 A1; hereafter Amin).
Regarding claim 8, Utz as modified discloses the fiber optic medical infusion line of claim 1, as described above.
Utz as modified is silent to wherein the distal end cap comprises a passive wireless one line antennae.
Twiss, in the art of catheters, teaches wherein the distal end (distal end of shaft 23, fig. 1D, pg. 8 ln. 29-30 “At the distal end of shaft 23, shielded wire 26 is connected to a conductive mass 24”) comprises a passive wireless one line antennae (conductive mass 24, fig. 1D, pg. 8 ln. 29-pg. 9 ln. 5 describes that conductive mass 24 receives a radiated signal and can then be used in combination with a transmitter/detector unit 2 for confirming the placement of the tip of guidewire shaft 23).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the distal end cap of Utz as modified to include an antenna as taught by Twiss, since Twiss also deals with inserting devices into the body. One would have been motivated to make the modification because, as noted by Twiss, pg. 8 ln. 29-pg. 9 ln. 5, the antenna can be used to confirm the placement of the tip of the inserted device. This would beneficially ensure that fluid and light delivered with the device of Utz are directed to the correct area of the body.
Alternatively, Utz as modified is silent to the antenna being passive and wireless.
Amin, in the art of medical devices implanted in the body, teaches wherein the device includes a passive wireless one line antenna (0025] The RFID tags 222A, 222B in the port 200 enables the system 100 to detect, identify, and locate the position of the port 200 after implantation within the patient.; [0026] In an embodiment, the RFID tags 222A, 222B can be passive RFID tags that do not require a power source but obtains energy from an interrogating signal, emitted by the detector 140. Advantageously this extends the useful life of the implanted medical device as it is not limited by a finite power source.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the antenna of Utz as modified to be a passive and wireless one line antenna as taught by Amin, since Amin also deals with medical devices placed within the body. One would have been motivated to make the modification because, as noted by Amin [0026], using a passive antenna “extends the useful life of the implanted medical device as it is not limited by a finite power source”.
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 ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 08/20/2026
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