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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-4, 7-10, 12, 14, 15, 17, 18, 20 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites, “a pouch made of a porous membrane disposed inside said filter unit,” which appears to have no support in the original disclosure. The disclosure only has:
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Fig. 4 shows the particles in the treatment bag without the pouch, and the filter unit 12 has the barrier means 6, but is not as a pouch in filter 12.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-4, 7-10, 12, 14, 15, 17, 18, 20 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As amended 9/28/26, claim 1 recites a filtration medium including one or more layers of a hydrophilic porous material upstream of the pouch, and meant to capture cellular components, particularly, leukocytes. The pouch is described as made of hydrophilic material and configured to prevent the passage of the small particles with the target substance. These particles are in the treatment bag. The particles are up to 15 microns in size. Leukocytes are 6-15 microns in size.
It is unclear how the pouch would capture the particles when there are one or more layers of the hydrophilic material upstream of the pouch capable of capturing leukocytes of particle size range 6-15 microns. Also unclear is the structure of the pouch inside the filter for it to capture the particles. There is no disclosure describing how the pouch is installed in the filter. The pouch is described as enclosing the particles, and the particles cannot pass through the pouch wall, but the biological fluid can pass through it to contact the particles. [0054]-[0056]. That is, the pouch is sealed on all sides, with particles inside. How would such a pouch capture the particles in the amended claim 1, even if somehow they pass through the upstream layers of hydrophilic material?
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) 1-4, 7-10, 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: for examination, the “pouch” in claim 1 is considered as just another layer of membrane material (barrier means 6) downstream of the leukocyte filter, which appears how applicant is describing it in the disclosure as cited Id.
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 microns 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. They are addressed in the rejection, and in prior actions.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem Singh can be reached on 5712720579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
