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 amendment filed 09/18/2025 is accepted and entered.
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive.
Applicant alleges that the current version of the Container website provides evidence that the Container reference was not available prior to December 3, 2020. However, this is not found persuasive. The archived version of the Container website is clearly time and date stamped at 5:53:53 GMT on March 28, 2019. Although the current version of the Container website has an image that states the article was “Added December 3, 2020”, this alone does not overcome the time and date stamp from the archived version of the Container website. There are a few differences between the archived version and the current version of the Container website. Notably, the title of the article on the archived version is “How to silk print barcodes and make them scannable” whereas the title of the article on the current version is “How to Screen Print Barcodes and Make Them Scannable”. It appears that the article received a new title, and that this new version of the article with the new title is what was “added December 3, 2020”. Applicant has not provided sufficient evidence to prove that the archived version of the Container website was not available to the public as of the relied upon date and time stamp.
Applicant also argues that it is not clear to the extent that the Container article can be relied upon for any determination of obviousness in the present context of printing a barcode on transparent tubing, since the article relates to printing barcodes on bottles/containers and not on tubing. This is not found persuasive. Clear plastic bottles and clear plastic tubing would be understood to have similar reflectance values despite the fact that one is a bottle and one is a tube. In turn, one of ordinary skill would find it obvious to look to methods of printing barcodes on clear plastic bottles to find improved ways of printing labels such as barcodes on clear plastic tubing. Since blood collection tubing would be expected to contain blood, which is red/dark red in color, one of ordinary skill in the art would look specifically to methods of printing barcodes on clear plastic bottles where the bottles will contain a dark fluid, as blood is a dark fluid. Applicant’s argument that the article identifies the recommended solution as being very counter-intuitive; however, this statement is in reference to the color of the printed barcode on a clear container where the liquid inside the container is also clear, which is not the case when the liquid is blood as in the prior art.
Additionally, Applicant argues that the article describes printing a reverse barcode, which involves printing a background box. Applicant argues that this is in contrast to the invention which has printed white bars instead of the traditional black bars of a standard barcode. However, this is not found persuasive. The reverse barcode described in the article, where a white background is printed, does result in printing white bars instead of printing black bars, as printing the white background necessarily involves printing white bars that are spaced apart by unprinted areas.
Applicant did not specifically argue the dependent claims.
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(s) 1, 2, 13, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Demay et al (US 2004/0182734) in view of Peddada et al (US 6566052) further in view of Qin et al (US 6328716) further in view of Container and Packaging (How to silk print barcodes and make them scannable, archived copy dated 03/28/2019 accessed via archive.org), hereinafter Container.
Regarding Claims 1 and 16, Demay discloses a blood donation system (1, Fig. 1) comprising:
a donor access device (needle 3, Fig. 1);
a first collection container (2, Fig. 1) having an inlet port and an outlet port (as seen in Fig. 1);
a first tubing (6, Fig. 1) connecting the donor access device (3, Fig. 1) to the inlet port of the first collection container (2, Fig. 1);
a leukocyte reduction filter (25, Fig. 1) having an inlet and an outlet (as seen in Fig. 1);
a second collection container (24a, Fig. 1) having an inlet port and an outlet port (as seen in Fig. 1);
a second tubing (23, Fig. 1) connecting the outlet port of the first collection container (2, Fig. 1) to the inlet of the leukocyte reduction filter (25, Fig. 1); and
a third tubing (unlabeled in Fig. 1) connecting the outlet of the leukocyte reduction filter (25, Fig. 1) to the inlet port of the second collection container (24a, Fig. 1);
wherein the system has a machine-readable identification code associated therewith (¶ [0053] indicates receptacles of the system are provided with a barcode identification tag),
wherein the biological fluid is blood (¶ [0003] indicates the invention is used typically for whole blood donation).
Demay is silent whether the machine-readable identification code is printed on one of the tubings at repeated intervals to define a plurality of discrete segments, each sized to contain a sample volume of biological fluid, wherein the tubing is transparent, and wherein the machine-readable identification code is a negative barcode.
Peddada teaches a blood collection system, thus being in the same field of endeavor, where a machine-readable identification code is printed on a tubing (32, Fig. 1) at repeated intervals (Col. 12 lines 50-67) to define a plurality of discrete segments (44, Fig. 2), each sized to contain a sample volume of biological fluid such as blood (Col. 7 lines 55-62). This allows for the blood to be rapidly tested for viral contamination and ensures the donation batch is properly identified (Col. 3 lines 16-44).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubings of Demay to have the machine-readable identification code printed on the tubings at repeated intervals to define a plurality of discrete segments, each sized to contain a sample volume of biological fluid such as blood, as taught by Peddada. This allows for the blood to be rapidly tested for viral contamination and ensures the donation batch is properly identified (Col. 3 lines 16-44).
Demay/Peddada is silent whether the tubing is transparent and the barcode is a negative barcode.
Although both Demay and Peddada are silent regarding the transparency of the blood tubing, one of ordinary skill in the art would recognize that blood tubing for blood donation and processing is typically transparent to allow the medical professional to visually monitor the tubing to ensure blood clots or air bubbles are not formed within the blood to ensure patient safety. Additionally, Qin provides evidence that clear PVC was widely used, as of 2001, to fabricate medical tubing (Col. 1 line 62 – Col. 2 line 9) and that medical tubing is desirably optically transparent to allow for visual inspection of fluids within the tubing (Col. 1 lines 25-30). Therefore, one of ordinary skill in the art, upon reading both Demay and Peddada, would expect that the blood tubing used would be transparent. However, in the instance that one of ordinary skill in the art would not reasonably expect that the blood tubing of Demay/Peddada is transparent, one of ordinary skill in the art would be motivated to modify the blood tubing of Demay/Peddada to be transparent, as taught by Qin, who indicates that medical tubing is desirably optically transparent to allow for visual inspection of fluids within the tubing (Col. 1 lines 25-30).
Demay/Peddada, or Demay/Peddada/Qin, is silent whether the barcode is a negative barcode.
Container teaches that when printing a barcode on a transparent container that will be filled with a dark product, a light colored reverse barcode should be used (pg. 3, “If dark product, reverse on clear” section). This ensures the barcode will scan based on the different reflectance values between the bars and spaces of the code (pg. 2, “How do barcodes scan?” and pg. 3, “If dark product, reverse on clear”).
Therefore, it would have been obvious to modify Demay/Peddada, or Demay/Peddada/Qin, to be an inverse barcode, as taught by Container. Container indicates that reverse barcodes are the preferred method for printing a bar code on a transparent container (as motivated by Container pg. 3 “If dark product, reverse on clear”) that will be storing a dark product, such as the blood of Demay/Peddada.
Regarding Claim 2, the combination of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Since the combination of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, has the machine-readable identification code printed on each of the tubings of Demay at repeated intervals, the machine-readable identification code will therefore be printed on the third tubing of Demay/Peddada/Container, or Demay/Peddada/Qin/Container.
Regarding Claim 13, the combination of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The plurality of discrete segments (44, Fig. 2) of Peddada are further defined by heat seals (42, Fig. 2) formed at intervals along the tubing (32, Fig. 1). Therefore, the combination of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, has the plurality of discrete segments further defined by heat seals formed at intervals along the tubing.
Regarding Claim 18, the combination of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The negative barcode of Container includes printed white bars in place of printed black bars of a standard barcode (pg. 2, “Reverse barcode” section and pg. 3, “If dark product, reverse on clear” section; printing the white background box will result in white bars being printed in the negative spaces of the barcode rather than the traditional black bars in the positive space of the barcode). Therefore, the combination of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, has the negative barcode includes printed white bars in place of printed black bars of a standard barcode.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Demay et al (US 2004/0182734) in view of Peddada et al (US 6566052) further in view of Qin et al (US 6328716) further in view of Container and Packaging (How to silk print barcodes and make them scannable, archived copy dated 03/28/2019 accessed via archive.org), hereinafter Container, further in view of Jansson et al (US 2018/0250454).
Regarding Claim 5, Demay/Peddada/Container, or Demay/Peddada/Qin/Container, is silent whether the first collection container is prefilled with a volume of anticoagulant.
Jansson teaches a blood collection system, thus being in the same field of endeavor, where the collection container is prefilled with a volume of anticoagulant (¶ [0002]) to ensure the blood does not clot before being infused into a patient.
Therefore, it would have been obvious to modify the first collection container of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, to be prefilled with a volume of anticoagulant, as taught by Jansson, to ensure the blood does not clot before being infused into a patient in need of blood.
Claim(s) 6, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Demay et al (US 2004/0182734) in view of Peddada et al (US 6566052) further in view of Qin et al (US 6328716) further in view of Container and Packaging (How to silk print barcodes and make them scannable, archived copy dated 03/28/2019 accessed via archive.org), hereinafter Container, further in view of Kluckner et al (US 2019/0277870).
Regarding Claims 6, 14, and 15, Demay/Peddada/Container, or Demay/Peddada/Qin/Container, is silent whether an alphanumeric equivalent of the machine-readable identification code is printed on each discrete segment of the tubing in conjunction with the machine-readable identification code, and wherein the alphanumeric equivalent of the machine-readable identification code is printed on at least one collection container, for example the first and second collection container.
Kluckner teaches a method of laboratory sample identification, thus being in the same field of endeavor, where identification labels include both a barcode and an alphanumeric indicia (¶ [0050]). This provides a redundant method of identification in case the machine is unable to read the machine-readable identification code.
Therefore, it would have been obvious to modify the machine-readable identification code of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, to have both the machine-readable barcode and an alphanumeric equivalent printed on each segment of the tubing as well as on the first and second collection container. Since the barcode of Demay/Peddada/Container, or Demay/Peddada/Qin/Container, is already present on each segment and each collection container, this modification is simply adding the alphanumeric equivalent to each printed barcode. This provides a redundant method of identification in case the machine is unable to read the machine-readable identification code.
Claim(s) 7, 11, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Peddada et al (US 6566052) further in view of Qin et al (US 6328716) further in view of Container and Packaging (How to silk print barcodes and make them scannable, archived copy dated 03/28/2019 accessed via archive.org), hereinafter Container.
Regarding Claims 7 and 17, Peddada discloses a blood donation system (abstract, Figs. 1-2) comprising a plurality of containers (donation bottle 20 and sample container 28, Figs. 1-2) interconnected by a plurality of tubing segments (34, 32, 26, Fig. 1), at least one tubing segment (32, Fig. 1-2) having a machine-readable identification code associated therewith printed on the tubing segment (32, Fig. 1-2) at repeated intervals (Col. 12 lines 50-67) to define a plurality of discrete sub-segments (44, Fig. 2), each sized to contain a sample volume of biological fluid such as blood (Col. 7 lines 55-63).
Peddada is silent whether at least one or more portions of the plurality of tubing sections are transparent, and the barcode is a negative barcode.
Although Peddada is silent regarding the transparency of the blood tubing, one of ordinary skill in the art would recognize that blood tubing for blood donation and processing is typically transparent to allow the medical professional to visually monitor the tubing to ensure blood clots or air bubbles are not formed within the blood to ensure patient safety. Additionally, Qin provides evidence that clear PVC was widely used, as of 2001, to fabricate medical tubing (Col. 1 line 62 – Col. 2 line 9) and that medical tubing is desirably optically transparent to allow for visual inspection of fluids within the tubing (Col. 1 lines 25-30). Therefore, one of ordinary skill in the art, upon reading Peddada, would expect that the blood tubing used would be transparent. However, in the instance that one of ordinary skill in the art would not reasonably expect that the blood tubing of Peddada is transparent, one of ordinary skill in the art would be motivated to modify the blood tubing of Peddada to be transparent, as taught by Qin, who indicates that medical tubing is desirably optically transparent to allow for visual inspection of fluids within the tubing (Col. 1 lines 25-30).
Peddada, or Peddada/Qin, is silent whether the barcode is a negative barcode.
Container teaches that when printing a barcode on a transparent container that will be filled with a dark product, a light colored reverse barcode should be used (pg. 3, “If dark product, reverse on clear” section). This ensures the barcode will scan based on the different reflectance values between the bars and spaces of the code (pg. 2, “How do barcodes scan?” and pg. 3, “If dark product, reverse on clear”).
Therefore, it would have been obvious to modify Peddada, or Peddada/Qin, to be an inverse barcode, as taught by Container. Container indicates that reverse barcodes are the preferred method for printing a bar code on a transparent container (as motivated by Container pg. 3 “If dark product, reverse on clear”) that will be storing a dark product, such as the blood of Demay/Peddada.
Regarding Claim 11, Peddada further discloses the plurality of discrete segments are further defined by heat seals (42, Fig. 2) formed at intervals along the tubing segment (32, Figs. 1-2).
Regarding Claim 19, the combination of Peddada/Container, or Peddada/Qin/Container, discloses the claimed invention substantially as claimed as set forth above for Claim 7.
The negative barcode of Container includes printed white bars in place of printed black bars of a standard barcode (pg. 2, “Reverse barcode” section and pg. 3, “If dark product, reverse on clear” section; printing the white background box will result in white bars being printed in the negative spaces of the barcode rather than the traditional black bars in the positive space of the barcode). Therefore, the combination of Peddada/Container, or Peddada/Qin/Container, has the negative barcode includes printed white bars in place of printed black bars of a standard barcode.
Claim(s) 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Peddada et al (US 6566052) further in view of Qin et al (US 6328716) further in view of Container and Packaging (How to silk print barcodes and make them scannable, archived copy dated 03/28/2019 accessed via archive.org), hereinafter Container, further in view of Kluckner et al (US 2019/0277870).
Regarding Claims 10 and 12, Peddada, or Peddada/Qin, is silent whether an alphanumeric equivalent of the machine-readable identification code is printed on each discrete segment of the tubing in conjunction with the machine-readable identification code, and wherein the alphanumeric equivalent of the machine-readable identification code is printed on at least one container.
Kluckner teaches a method of laboratory sample identification, thus being in the same field of endeavor, where identification labels include both a barcode and an alphanumeric indicia (¶ [0050]).
Therefore, it would have been obvious to modify the machine-readable identification code of Peddada, or Peddada/Qin, to have both the machine-readable barcode and an alphanumeric equivalent printed on each segment of the tubing as well as on at least one container. Since the barcode of Peddada, or Peddada/Qin, is already present on each segment and each collection container, this modification is simply adding the alphanumeric equivalent to each printed barcode. This provides a redundant method of identification in case the machine is unable to read the machine-readable identification code.
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.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781