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 claims 1-18 in the reply filed on 12/4/24 is acknowledged.
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.
Claim(s) 1-12, 14, 15, 17, 18, 20 and 21 rejected under 35 U.S.C. 103 as unpatentable over Sowemimo-Coker (US 2012/0219633; “Coker”) in view of Pall et al (US 5,344,561), or, EP 03953361
Claim 1: Figs. 4 and 1 of Coker are copied herein, side-by-side, with some annotations. Figure 4, similar to applicant’s invention, shows a blood bag 700 having a sealed leukocyte filter pouch 750 containing adsorbent particles inside, the pouch has an inlet port 701, and the bag has outlet port 702 Particle size of adsorbents are 10-500 microns [0039], which overlaps the claimed range of <15 microns. Coker teaches in examples the commercially available Pall leukocyte filter, which has similar structure as claimed, that is pore size decreasing from upstream to downstream, but does not seem to teach the pore size of less than or equal to 3 micron downstream. However, Coker taches in [0048]: “While it is believed leukocytes are primarily removed by adsorption, they can also be removed by filtration. The pore structure can be selected to remove at least some level of leukocytes, while allowing the passing therethrough of desired components, e.g., at least one of plasma, platelets, and red blood cells. The pore structure used depends on the composition of the fluid to be treated, and the desired effluent level of the treated fluid.”
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Corker cites multiple references to Pall of Pall corporation for leukocyte filters. Therefore, it would have been obvious to one of ordinary skill in the art to look up references to Pall for such filter. Pall-561 teaches a high efficiency leukocyte filter (abstract) with pore size 0.5 – 2.0 microns (col. 9 lines 52-55). The Pall filter is hydrophilic (see claim 15 of Pall.) Therefore, it would have been obvious to one of ordinary skill to use the Pall teaching and use the “high efficiency leukocyte-depletion filter” in Corker’s teaching.
Applicant also uses similarly known commercially available filter as disclosed in [0078.]. Therefore, it would also have been obvious to resource suitable commercially available filters such as taught by EP 03953361 for the leukocyte suitable for the intended use as in Coker. See MPEP 2143, Rationales A-G.
The filter arrangement is also described in [0011]. Regarding the adsorbent particle size, Coker teaches 150 microns or less, and a range 10-500 microns, which overlaps the claimed range. Since there appears no criticality for the particle size, the claims are obvious if not anticipated. Also, according to [0028] of the specification, the adsorbent particles are commercially available. Using a commercial product for its intended purpose is prima facie obvious.
Claims 2 and 3: Filter is hydrophilic with same/similar materials with CWST [0044]-[0049]. See the incorporated reference to Pall in example 2 and [0105].
Claim 4: see fig. 4 for transfer tubing.
Claims 5, 6, 9-13: already covered in claim 1 above.
Claim 14: transfer bag – 20 and 25, fig. 4. Filter unit 600/900 in tubing is seen in fig. 1 and 3.
Claims 15-18: see fig. 2 A&B, [0044]-[0049].
Claims 7 and 8, double wall pouch and double peripheral seal: example 1, [0074] teaches the pouch as having multiple layers, with the sorbent media inside, and heat-sealed around the edges. Having two seals for redundancy of the seal would have been obvious to one of ordinary skill (evidence: Verri et al, US 2017/0136167; EP’361), and is not patentable unless otherwise shown. Applicant uses commercially available filer as cited in [0078].
New claims 20 and 21: the biological fluid is only material worked upon, and is not patentable. Nonetheless, the reference is for the same application. Hydrophilic material being cellulose acetate – see Pall, cited in Coker as the filter material in Example 2, incorporated by reference in [0105].
Response to Arguments
Applicant's arguments filed 3/6/26 have been fully considered but they are not persuasive.
Argument:
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This mesh is upstream, it is taught as optional in the cited paragraphs, and is larger in pore size than the downstream filters. Irrespective of what function it is supposed to have in Pall, applicant’s claims do not exclude such a structure.
Arguments:
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In response to applicant’s argument that there is no motivation to combine the references in Coker, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, since Koker taches using Pall leukocyte filters for the purpose, it would have been obvious to find a suitable Pall filter for that purpose, which suggestion is coming, in fact, from Coker.
Arguments citing particle sizes of leukocytes and other blood cells are not persuasive, because, (1) applicant’s invention is also “adapted for removing leukocytes from blood” blood as disclosed in [0074], and (2) Coker patent is also intended for “platelet-poor plasma (PPP), platelet-free plasma, plasma, fresh frozen plasma (FFP),meant for use with plasma,” etc. Therefore, the modification of Coker sought by one of ordinary skill in the art can be geared for such application.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the references may be teaching several alternate or optional arrangements in the filter structure. Such details do not disqualify the references. The obviousness analysis is based on whether the teachings of the references as combined would make the claims obvious. Such arguments are also not commensurate in scope with the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777