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 Amendment
The Amendment filed on 5/27/2026 has been entered. Claims 1-20 remain pending in the application. Claims 10-20 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 3/4/2026.
Applicants amendments to the drawings have overcome the drawing objections previously set forth in the Non-final Office Action mailed 3/4/2026.
Applicants amendments to the abstract have overcome the abstract objections previously set forth in the Non-final Office Action mailed 3/4/2026.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer (U.S Patent no 6613036) further in view of Horowitz (U.S. PG publication 20090036874).
In regard to claim 1,
Farmer discloses a light protective infusion set component (figure 1, item 10; column 4, line 56-60; column 2, line 46-57), comprising:
an infusion set component (figure 1, item 12, 26, 28, and tubing connected to either item 26 or 28 shown in figure 5A and 5B; column 4, line 56-60), wherein a portion of the infusion set component is translucent (column 3, line 4-8: the container is translucent), providing visibility within the infusion set component (column 3, line 4-8); and
an infusion set layer (figure 1, item 14) comprising:
a layer of flexible light protective material (figure 1, item 14; column 2, line 49-57) having a filter for blocking a predetermined range of light wavelengths (column 2, line 53-57 and column 3, line 21-29); and
wherein the infusion set layer is disposed around an exterior surface of the translucent portion of the infusion set component (column 3, line 4-10; see figure 5B and 5A).
Farmer is silent as to a bonding layer configured for adherence to the infusion set component, wherein the infusion set layer is disposed around and adhered to an exterior surface of the translucent portion of the infusion set component.
Horowitz teaches a bonding layer (figure 1, item 134) configured for adherence to the infusion set component (paragraph [0020]), wherein the infusion set layer is disposed around and adhered to an exterior surface of the infusion set component (paragraph [0020]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set layer of Farmer to include a bonding layer configured for adherence to the infusion set component, therefore resulting in wherein the infusion set layer is disposed around and adhered to an exterior surface of the translucent portion of the infusion set component, as taught by Horowitz, for the purpose of preventing inadvertent exposure of the infusion set component (paragraph [0020] of Horowitz).
In regard to claim 2,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the filter is configured to allow no more than 35 percent of ultraviolet light to pass through the layer of flexible light protective material (column 3, line 21-29 of Farmer).
In regard to claim 3,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the filter is configured to block ultraviolet light from passing through the layer of flexible light protective material (column 3, line 21-29 of Farmer and column 7, line 7-19 of Farmer).
In regard to claim 4,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the bonding layer comprises an adhesive layer disposed on one side of the layer of flexible light protective material (see analysis of claim 1 above and paragraph [0020] of Horowitz).
In regard to claim 5,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the bonding layer comprises a self-sticking property (see analysis of claim 1 above and paragraph [0020] of Horowitz; Examiner notes the bonding layer/adhesive is fully capable of sticking to itself).
In regard to claim 6,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the layer of flexible light protective material comprises a colored pigment (column 7, line 33-42 of Farmer and column 7, line 57-63 of Farmer).
In regard to claim 7,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the layer of flexible light protective material is translucent (column 7, line 27-42 of Farmer).
In regard to claim 8,
Farmer in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the layer of flexible light protective material is formed of a material rated for infusion procedures (column 1, line 8-13 of Farmer and column 38-46 of Farmer).
Claims 1-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimura (JP 2014057657) further in view of Warren (U.S. PG publication 20190392923) further in view of Horowitz (U.S. PG publication 20090036874). Examiner notes reference is made to the previously attached English translation of Fujimura (JP 2014057657).
In regard to claim 1,
Fujimura discloses a light protective infusion set component (see all of figure 1; page 2, line 32-45 of the previously attached English translation: “In order to solve the above problem, the catheter light shielding cover according to the first aspect of the present invention shields light”), comprising:
an infusion set component (figure 1, item 4), wherein a portion of the infusion set component is transparent (page 2, line 52-53 of the previously attached English translation: “the catheter and the liquid flowing through the transparent catheter can be visually recognized”), providing visibility within the infusion set component (page 2, line 52-53 of the previously attached English translation); and
an infusion set layer (figure 1, item 1C) comprising:
a layer of flexible light protective material (figure 1, item 1C; page 3, line 29 of the previously attached English translation: “Since the light shielding sheets 1c and 1d have flexibility”) having a filter for blocking a predetermined range of light wavelengths (page 2, line 32-45 of the previously attached English translation),
wherein the layer of flexible light protective material is disposed around an exterior surface of the transparent portion of the infusion set component (see figure 1).
Fujimura fails to disclose wherein a portion of the infusion set component is translucent, and a bonding layer configured for adherence to the infusion set component. Accordingly, Fujimura also fails to disclose wherein the infusion set layer is disposed around and adhered to an exterior surface of the translucent portion of the infusion set component.
Warren teaches wherein a portion of the infusion set component (figure 1A, item 32) is translucent (paragraph [0030]).
Further, Warren teaches that a transparent tubing or a translucent tubing could all be used to achieve the same result (paragraph [0030]) and thus a transparent tubing and a translucent tubing were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a translucent tubing in place of the transparent tubing of Fujimura since it has been held that substituting parts of an invention involves only routine skill in the art. Examiner notes the substitution would result in wherein the infusion set layer of Fujimura is disposed around an exterior surface of the translucent portion of the infusion set component.
Fujimura in view of Warren fails to disclose a bonding layer configured for adherence to the infusion set component. Accordingly, Fujimura also fails to disclose wherein the infusion set layer is disposed around and adhered to an exterior surface of the translucent portion of the infusion set component.
Horowitz teaches a bonding layer (figure 1, item 134) configured for adherence to the infusion set component (paragraph [0020]), wherein the infusion set layer is disposed around and adhered to an exterior surface of the infusion set component (paragraph [0020]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set layer of Fujimura in view of Warren to include a bonding layer configured for adherence to the infusion set component, therefore resulting in wherein the infusion set layer is disposed around and adhered to an exterior surface of the translucent portion of the infusion set component, as taught by Horowitz, for the purpose of preventing inadvertent exposure of the infusion set component (paragraph [0020] of Horowitz).
In regard to claim 2,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the filter is configured to allow no more than 35 percent of ultraviolet light to pass through the layer of flexible light protective material (page 2, line 43-45 of the previously attached English translation of Fujimura).
In regard to claim 3,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the filter is configured to block ultraviolet light from passing through the layer of flexible light protective material (page 2, line 43-45 of the previously attached English translation of Fujimura).
In regard to claim 4,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the bonding layer comprises an adhesive layer disposed on one side of the layer of flexible light protective material (see analysis of claim 1 above and paragraph [0020] of Horowitz).
In regard to claim 5,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the bonding layer comprises a self-sticking property (see analysis of claim 1 above and paragraph [0020] of Horowitz; Examiner notes the bonding layer/adhesive is fully capable of sticking to itself).
In regard to claim 6,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the layer of flexible light protective material comprises a colored pigment (page 2, line 46-48 of the previously attached English translation of Fujimura).
In regard to claim 8,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the layer of flexible light protective material is formed of a material rated for infusion procedures (page 4, line 8-9 of the previously attached English translation of Fujimura; see figure 1 of Fujimura; page 3, line 11-19 of the previously attached English translation of Fujimura).
In regard to claim 9,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the infusion set component is intravenous tubing (figure 1, item 4 of Fujimura; page 3, line 11-19 of the previously attached English translation of Fujimura).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fujimura (JP 2014057657) in view of Warren (U.S. PG publication 20190392923) in view of Horowitz (U.S. PG publication 20090036874) further in view of Farmer (U.S Patent no 6613036).
In regard to claim 7,
Fujimura in view of Warren in view of Horowitz teaches the light protective infusion set component of claim 1, wherein the layer of flexible light protective material is transparent (page 4, line 3-7 of the previously attached English translation of Fujimura).
Fujimura in view of Warren in view of Horowitz is silent as to wherein the layer of flexible light protective material is translucent.
Farmer teaches wherein the layer of flexible light protective material (figure 1, item 14; column 2, line 49-57) is translucent (column 7, line 27-42).
Further, Farmer teaches that a transparent material or a translucent material could all be used to achieve the same result (column 7, line 27-37 of Farmer) and thus a transparent material or a translucent material were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a translucent material in place of a transparent material since it has been held that substituting parts of an invention involves only routine skill in the art. Additionally Fujimura supports the degree of transparency is not limited (page 4, line 3-7 of the previously attached English translation of Fujimura).
Response to Arguments
Applicant argues in regard to the claim objections that the published application US 2024/0261496 correctly lists claims 4-9 and therefore no correction is believed to be required. It is noted that the claims filed on 5/27/2026 do not include the extra spacing, and therefore the claim objections are withdrawn.
Applicant's arguments filed 5/27/2026 in regard to the 102 rejections and the 103 rejections have been fully considered but they are not persuasive. Applicant argues that Horowitz (U.S. PG publication 20090036874) fails to disclose the removal mechanism 238 adheres to an outer surface of the catheter system 102. As detailed above, attachment 134 of Horowitz is adhered to the infusion set component as described in paragraph [0020] of Horowitz. Therefore, Horowitz does teach a bonding layer configured for adherence to the infusion set component.
Applicant argues that Fujimura teaches away from the substitution of translucent for transparent. Applicant argues that replacing transparent material with translucent material would impair a clinician to visually recognize the catheter and the flowing liquid through a transparent catheter. It is noted that a translucent tubing would still enable a clinician to visually recognize the catheter and the flowing liquid as supported by paragraph [0030] of Warren which specifically states: Tubing 32 and drip chamber 34 typically are transparent or translucent to provide a visual indication of the flow. As a translucent tubing would still enable a visual indication of the flow as supported by Warren, Applicant’s arguments are not found to be persuasive.
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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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