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 12/15/2025 has been entered. Claims 1-19 and 21-27 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection previously set forth in the non-final Office Action mailed 8/27/2025.
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.
Claim(s) 15, 16-19, 21-24 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent No. 5,128,048, hereinafter Stewart.
Regarding claim 15, Stewart teaches a biomedical device (figures 2 and 3) for preparing blood components (intended use MPEP § 2114 (II) and is taught in the abstract), comprising: a first bag (item 16); a second bag (item 32); and a third bag (item 30), wherein said first bag (item 16) is connected to the second bag (item 32) and to the third bag (item 30); wherein said second bag (item 32) is adapted to contain plasma (intended use MPEP § 2114 (II) and is taught in column 5, lines 10-14) and a platelet pad (intended use MPEP § 2114 (II)) and a re-suspended platelet concentrate (intended use MPEP § 2114 (II) and is taught in column 5, lines 10-14); and wherein said third bag (item 30) is adapted to contain platelet-poor plasma (intended use MPEP § 2114 (II) and is taught in column 5, lines 10-14); a storage bag (item 28), fluidly connected to the first bag (item 16) by a main cannula (item 26); a leukoreduction filter (item 36) arranged in the main cannula (figures 2 and 3); and a solution bag (item 18), comprising a tributary cannula (item 20); said solution bag (item 18) being separated from the main cannula (figures 2 and 3) and being fluidly connectable to a secondary cannula (figures 2-3), branching off from the main cannula (figure 2-3), by means of a sterile connection between the tributary cannula (figures 2-3) and the secondary cannula (figure 2-3); wherein the first bag (item 16 is adapted to contain a blood sample (intended use MPEP § 2114 (II) and is taught in column 4, lines 54-58) and a red blood cell concentrate (intended use MPEP § 2114 (II)), wherein the solution bag (item 18) is adapted to contain an additive solution (intended use MPEP § 2114 (II) and is taught in column 7, lines 66-67) for red blood cell storage; wherein said leukoreduction filter (item 36) is adapted to filter the concentrated red blood cell suspension towards the storage bag (figure 3), and wherein the storage bag (item 28) is adapted to contain a filtered concentrated red blood cell suspension (intended use MPEP § 2114 (II) and is taught in figure 3).
Regarding claim 17, Stewart teaches wherein the second bag (item 32) comprises a connecting tube (the tube where item 52 is on) connected to the second bag (figures 2-3) at an upper region of the second bag (figures 2-3).
Regarding claim 18, Stewart teaches wherein the second bag (item 32) comprises a blind tube (the tube coming out of item 32) placed at the upper region of the second bag (figures 2 and 3), and the connecting tube is inserted with a "Y" fitting on the blind tube (figures 2 and 3).
Regarding claim 19, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Stewart and the apparatus of Stewart is capable of inputting the additive solution in the opposite direction of the flow of red blood cell concentrate. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Stewart (see MPEP §2114). Further, this limitation is taught in figure 3).
Regarding claim 21, Stewart teaches wherein the leukoreduction filter (item 36) is placed upstream, with reference to the flow of the concentrated red blood cell suspension from the first bag to the storage bag, of the intersection between the main cannula and the secondary cannula (figure 3).
Regarding claim 22, Stewart teaches wherein the leukoreduction filter (item 36) is placed downstream, with reference to the flow of the red blood cell concentrate from the first bag to the storage bag, of the intersection between the secondary cannula and the tributary cannula (figure 3).
Regarding claim 23, Stewart teaches wherein a first and a second secondary cannula (the bypass tube of item 38 and the tube of flow 40) branch off from the main cannula (figures 2 and 3), and the leukoreduction filter (item 36) is between the intersection between the main cannula and the first secondary cannula, and between the intersection between the main cannula and the second secondary cannula (figures 2 and 3).
Regarding claim 24, Stewart teaches wherein the first bag, the second bag and the third bag are made of a flexible material which is resistant to a 2000 rpm centrifugation with a duration of 15 minutes (column 6, lines 33-44).
Regarding claim 26, Stewart teaches a system for preparing blood components (figures 2 and 3), comprising: a biomedical device according to one of claim 15 (see supra), at least one centrifuge (column 4, lines 59-65), at least one plasma extractor (item 54).
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.
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of United States Application Publication No. 2020/0289738, hereinafter Allard.
Regarding claim 16, Stewart teaches all limitations of claim 15; however, Stewart fails to teach a siphon fluidly connecting the second bag to the third bag.
Allard teaches a blood separation device in which a siphon is utilized from separate the plasma rich plasma from the sample (Allard, paragraph [0087]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a siphon between the second and third bags because it would allow for the separation of the plasma rich plasma from the rest of the plasma (Allard, paragraph [0087]).
Claim(s) 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of United States Patent No. 6,019,716, hereinafter Forestell.
Regarding claim 25, Stewart teaches all limitations of claim 15; however, Stewart fails to teach the volumes of the first, second and third bags, the solution bag and the storage bag.
Forestell teaches that the size and volume of the bag will be chosen based upon the use to which the bag will be used and the volume of fluid to be held or amount of material to be separated (Forestell, column 6, lines 18-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum inner volumes to a range of 150 ml for the first bag, 60 ml for the second bag, 60 ml for the third bag, 50 ml for the solution bag and 150 ml for the storage bag which would allow the size and volume of the bag will be chosen based upon the use to which the bag will be used and the volume of fluid to be held or amount of material to be separated (Forestell, column 6, lines 18-21) (MPEP § 2144.05 (II)).
Regarding claim 27, Stewart teaches all limitations of claim 26; however, Stewart fails to teach wherein at least one centrifuge comprises a protective tubular flexible casing and cylindrical adapters made of solid plastic.
Forestell teaches a centrifuge bag-holding device with clamp assembly which has a protective tubular flexible casing (Forestell, item 40) and cylindrical adapters made of solid plastic (Forestell, items 12 and 14) so that bags are able to be inserted into a standard centrifugation buck in a centrifuge (Forestell, abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the bag centrifuge holding device of Forestell because it would allow for bags to be inserted into a standard centrifugation buck in a centrifuge (Forestell, abstract).
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Stewart does not disclose a solution bag being separated from a main cannula and being fluidly connectable to a secondary cannula, branching off the main cannula, by means of a sterile connection between the tributary cannula and the secondary cannula is not found persuasive. Firstly, the claim is written as the “a solution bag being separated from a main cannula and being fluidly connectable to a secondary cannula.” The claim utilizes the term “connectable” to the secondary cannula, and therefore, the prior art only needs to be capable of having the solution bag connected to the main cannula through the secondary cannula. It would be possible in Stewart to add a secondary cannula which is connected to the main cannula and to the tributary cannula to connect the solution bag. Therefore, Stewart anticipates the claim as written. Additionally, the tee which connects item 20 (the tributary cannula) and item 26 (the main cannula) could be considered to be the second cannula thereby also reading on the claims in this manner as well.
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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796