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 group I and species A in the reply filed on 2/12/2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/12/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/5/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: item 190. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The abstract of the disclosure is objected to because:
Line 8 recites “a light protective infusion set component”. Line 1 introduces a light protective infusion set component. If the light protective infusion set component in line 8 is intended to be the same as line 1, Examiner suggests replacing “a light protective infusion set component” in line 8 with “the light protective infusion set component” to put the abstract in clearer form. If intended to be broad, no amendment is needed.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 4 objected to because of the following informalities:
Line 1-2 recites “of claim 1 ,”. This is grammatically incorrect. Examiner suggests removing the extra space between “of” and “claim” and removing the space between “1” and “,”.
Claim 5 objected to because of the following informalities:
Line 1-2 recites “of claim 1 ,”. This is grammatically incorrect. Examiner suggests removing the extra space between “of” and “claim” and removing the space between “1” and “,”.
Claim 6 objected to because of the following informalities:
Line 1-2 recites “of claim 1 ,”. This is grammatically incorrect. Examiner suggests removing the extra space between “of” and “claim” and removing the space between “1” and “,”.
Claim 7 objected to because of the following informalities:
Line 1-2 recites “of claim 1 ,”. This is grammatically incorrect. Examiner suggests removing the extra space between “of” and “claim” and removing the space between “1” and “,”.
Claim 8 objected to because of the following informalities:
Line 1-2 recites “of claim 1 ,”. This is grammatically incorrect. Examiner suggests removing the extra space between “of” and “claim” and removing the space between “1” and “,”.
Claim 9 objected to because of the following informalities:
Line 1-2 recites “of claim 1 ,”. This is grammatically incorrect. Examiner suggests removing the extra space between “of” and “claim” and removing the space between “1” and “,”.
Claim Rejections - 35 USC § 102
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 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 1-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer (U.S Patent no 6613036).
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; 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
a layer of flexible light protective material (figure 1, item 14; column 2, line 49-57) having a filter for a predetermined range of light wavelengths (column 2, line 53-57 and column 3, line 21-29),
wherein the layer of flexible light protective material is disposed around an exterior surface of the translucent portion of the infusion set component (column 3, line 4-10).
In regard to claim 2,
Farmer discloses 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).
In regard to claim 3,
Farmer discloses 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 and column 7, line 7-19).
In regard to claim 4,
Farmer discloses the light protective infusion set component of claim 1, further comprising:
an adhesive layer disposed on one side of the layer of flexible light protective material (column 2, line 58-column 3, line 3 and column 10, line 27-29).
In regard to claim 6,
Farmer discloses 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 and column 7, line 57-63).
In regard to claim 7,
Farmer discloses the light protective infusion set component of claim 1, wherein the layer of flexible light protective material is translucent (column 7, line 27-42).
In regard to claim 8,
Farmer discloses 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 and column 38-46).
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.
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.
Claim 5 is 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 5,
Farmer discloses the light protective infusion set component of claim 1.
Farmer is silent as to wherein the layer of flexible light protective material comprises a self-sticking property.
Horowitz teaches wherein the layer of flexible material (figure 1, item 104; paragraph [0021]) comprises a self-sticking property (paragraph [0032] wherein a self-sealing adhesive or cling-type material can be utilized to enable opening of the cover).
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 Farmer to substitute the attachment mechanism of the sleeve 14 of Farmer for the layer of flexible material comprising a self-sticking property, as taught by Horowitz, therefore resulting in wherein the layer of flexible light protective material comprises a self-sticking property because the substitution is a simple substitution that would yield the same predictable result of enabling a cover to be opened (see paragraph [0032] of Horowitz and column 2, line 58-column 3, line 3 and column 10, line 27-29 of Farmer). Furthermore, Farmer discloses modifications can be made (column 12, line 45-54 of Farmer).
Additionally, it would have been an obvious matter of design choice to modify Farmer to include wherein the layer of flexible light protective material comprises a self-sticking property since applicant has not disclosed that having wherein the layer of flexible light protective material comprises a self-sticking property solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the layer of flexible light protective material comprises a self-sticking property, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes based on the instant disclosure, it appears an adhesive or material with a self-sticking property can be equivalently used.
Claims 1-4, 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). 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
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 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. Accordingly, Fujimura also fails to disclose wherein the layer of flexible light protective material is disposed around 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 layer of flexible light protective material of Fujimura is disposed around an exterior surface of the translucent portion of the infusion set component.
In regard to claim 2,
Fujimura in view of Warren 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 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 teaches the light protective infusion set component of claim 1.
A first embodiment of Fujimura in view of Warren is silent as to an adhesive layer disposed on one side of the layer of flexible light protective material.
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A second embodiment of Fujimura teaches an adhesive layer (figure 12a, item 74C;s see page 8, line 31-43 of the previously attached English translation of Fujimura: “Separated into layers 73c and 73d, a resealable tape 74 includes a first tape portion 74C composed of a tape base material 72c and an adhesive layer 73c, and a second tape composed of a tape base material 72d and an adhesive layer 73d. The tape portion 74D is divided. Further, when the first tape portion 74C and the second tape portion 74D are pressed in the opposing direction, the adhesive layers 73c and 73d are reattached. Thereby, the bonding part 71B is resealed) disposed on one side of the layer of flexible light protective material (figure 12a, item 1C).
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 first embodiment of Fujimura in view of Warren to include an adhesive layer disposed on one side of the layer of flexible light protective material, as taught by the second embodiment of Fujimura , for the purpose of enabling reopening and resealing quickly (page 8, line 36-48 of the previously attached English translation of Fujimura).
In regard to claim 6,
Fujimura in view of Warren 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 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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over (JP 2014057657) in view of Warren (U.S. PG publication 20190392923) further in view of Horowitz (U.S. PG publication 20090036874).
In regard to claim 5,
Fujimura in view of Warren teaches the light protective infusion set component of claim 1.
Fujimura in view of Warren is silent as to wherein the layer of flexible light protective material comprises a self-sticking property.
Horowitz teaches wherein the layer of flexible material (figure 1, item 104; paragraph [0021]) comprises a self-sticking property (paragraph [0032] wherein a self-sealing adhesive or cling-type material can be utilized to enable opening of the cover).
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 Fujimura in view of Warren to substitute the attachment between sheet 1C and 1B of Fujimura for the layer of flexible light protective material comprising a self-sticking property, as taught by Horowitz, therefore resulting in wherein the layer of flexible light protective material comprises a self-sticking property because the substitution is a simple substitution that would yield the same predictable result of enabling a cover to be sealed (see paragraph [0032] of Horowitz and page 4, line 61-page 5, line 2 of the previously attached English translation of Fujimura).
Additionally, it would have been an obvious matter of design choice to modify Fujimura in view of Warren to include wherein the layer of flexible light protective material comprises a self-sticking property since applicant has not disclosed that having wherein the layer of flexible light protective material comprises a self-sticking property solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the layer of flexible light protective material comprises a self-sticking property, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes based on the instant disclosure, it appears an adhesive or material with a self-sticking property can be equivalently used.
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) further in view of Farmer (U.S Patent no 6613036).
In regard to claim 7,
Fujimura in view of Warren 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 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Baker (U.S. Patent no 5489022) discloses a light protective infusion set (see figure 1).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783