DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on January 26, 2026, have been received and entered.
Claim Disposition
3. Claims 10, 13, 17, 20-21 and 26-28 are canceled. Claims 1-9, 11-12, 14-16, 18-19, 22-25 and 29-30 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statements filed on April 21, 2026, November 26, 2024, December 13, 2024 and December 18, 2024, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Claim objection
5. Claims 1-9, 11-12, 14-16, 18-19, 22-25 and 29-30 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “A method of filtering solids from a solution derived from blood plasma, [[the method]] comprising:
Feeding…..solids content [[with respect to]] for the solution fed into the hollow…..”.The dependent claims hereto are also included.
For clarity it is suggested that claim 3 is amended to recite, “……rate us [[defined by]] is a cross flow velocity of [[from]] about….”.
For clarity it is suggested that claims 4-5, 11, 14 and 18 are amended to delete ‘from’ in front of “about”. The dependent claims hereto are also included.
For clarity it is suggested that claim 7 is amended to delete “at least” in front of ‘about’.
For clarity it is suggested that claim 19 is amended to read, “…..comprises one or more selected from the group consisting of: hemopexin, albumin……”.
For clarity and precision of claim language it is suggested that claim 24 is amended to delete “between” in front of “about”.
For clarity it is suggested that claim 25 is amended to recite, “….wherein [[a]] recovery of the permeate is…”.
For clarity it is suggested that claim 29 is amended to recite, “….wherein [[a]] turbidity of the permeate is…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claim(s) 1, 4-6, 14-16 and 30 is/are rejected under 35 U.S.C. 102(a1) and (a2) as being anticipated by B. Braun Carex (EP 1002566, 2000, of record in the application).
The primary reference discloses a filter for adsorbing heparin
and/or endotoxins in blood and/or plasma comprises an axially hollow cylindrical containment body (2) which is provided, at its inlet (2a) and outlet (2b) ends, with corresponding access ports (3, 4) formed in end caps (5, 6) and which internally accommodates a filtering medium (7) with microporous fibres (8) arranged in multiple layers, wrapped concentrically in a roll (hollow fibre membrane), (see abstract; figures 1-6; para [0001], [0008], [0014], [0015]-[0020], [0038]; claims 1-19). Claims 4-6 with the features of the average pore size, transmembrane pressure and permeate flux is disclosed in in the reference (see entire document). The temperature of the solution is between 4-37°C and discloses that the solution comprises blood plasma fraction. Further, the solution comprises a buffer (see para [0008] in primary reference). The solution comprises albumin/immunoglobulin G (see entire reference). Therefore the limitations of the claims are met by the reference.
7. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a1) and (a2) as being anticipated by US2016/0074569 (2016, of record in the application).
The primary reference discloses a whole blood hollow fibre membrane filter
medium being made of a polymeric material having pores of a pore size that ensures permeability to blood plasma or serum but retains blood cells. The whole blood hollow fibre membrane filter medium is used for filtering a whole blood sample so that blood plasma or serum passes through the whole blood hollow fibre membrane filter medium and blood cells are retained, (see abstract; figure 2; para [0002], [0070], [0105], [0114]; claims 1-35). The claim is a product by process claim which is disclosed in the reference are not novel. Therefore the limitations of the claims are met by the reference.
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.
8. 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.
9. Claim(s) 1-9, 11-12, 14-16, 18-19, 22-25 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP10002566 (of record in the application) or US2016/0074569, (of record in the application), in view of Coffinier et al. (J. Of Membrane Sci, vol. 208, iss. 1-2, Oct 2002, pages 13-22).
The teachings of EP10002566 and US2016/0074569 are above pertaining to claims 1, 4-6, 14-16 and 30, however these references do not teach all the limitations of claim 2, to recycle retentate into solution for feeding into the hollow fiber filter. None of the references disclose the features of recycling the retentate; parametric value of the permeate flux; the solution having a pH in a range; and the minimum recovery of the permeate as a percentage and turbidity; but Coffinier et al. does.
Coffinier et al. discloses that to replace conventional bioaffinity ligand like protein A or protein G, pseudobioaffinity ligands seem to be an interesting alternative for the purification of IgG. Coffinier et al. disclose that thiophilic ligand (T-gel) was immobilized on a copolymer of ethylene and vinyl alcohol (PEVA) based hollow fiber membrane to obtain an affinity support for the purification of IgG from human plasma. Microporous hollow fibers have been modified via divinyl sulfone activation and coupled by 2-mercaptoethanol (T-PEVA). The affinity module allowed the purification of IgG from human plasma with high efficiency (85% of IgG loaded were adsorbed) with a very small contamination of albumin (<1%). The enrichment was quite high (IgG/albumin) as shown by a final ratio of 39.3/0.27 before loading. The binding capacity could allow the separation of 1.5 g of IgG from human plasma with a functionalized membrane surface area of 1 m2. Coffinier et al. discloses that they tried to minimize sample preparation by decreasing the salt concentration, the sample dilution and by optimizing the rinsing and elution steps. This thiophilic derivatized hollow fiber module proved that it could be used as a very efficient tool for the purification of IgG provided that high concentration of salt was added (see abstract). Coffinier et al. teaches back flush wash and cross flow filtration mode (see pages 1-4).
The primary reference relate to arrangements that are matters of design choice for a person skilled in the art (PSA), do not provide any surprising results/unexpected advantages to the invention, and therefore do not contribute to providing a patentable inventive step. The features of recycling the retentate back into the solution is a matter of design choice for a PSA in light of the disclosure of anyone of the cited references above and common general knowledge in the art. The feature of the cross flow velocity is a matter of experimentation and optimisation of parameters for a PSA in light of
the disclosure of anyone of references and common general knowledge in the art.
The parametric value of the permeate flux is a matter of experimentation and optimisation of parameters for a PSA in light of the disclosure of anyone of the references and common general knowledge in the art.
The method comprising multiple filtering systems and a backwash solution are matters of design choice for a PSA in light of the disclosure of anyone of the references and common general knowledge in the art.
The features of the conductivity of the solution is a matter of experimentation and optimisation of parameters for a
PSA in light of the disclosure of anyone of the aforementioned references and common general knowledge in the art. The feature of using sodium acetate or phosphate as a buffer is a matter of design choice for a PSA in light of the disclosure of anyone of the references and common general knowledge in the art.
The feature of the solution having an extraction ratio between a range is a matter of experimentation and optimisation of parameters for a PSA in light of the disclosure of anyone of the cited references and common general knowledge in the art.
The feature of the solution comprising hemopexin is a matter of design choice for a PSA in light of the disclosure of anyone of the cited referenced and common general knowledge in the art. The feature of adding octanoic acid to the permeate is a matter of design choice for a PSA in light of the disclosure of anyone of the reference and common general knowledge in the art.
The feature of the solution comprising a filter aid is a matter of design choice for a PSA in light of the disclosure of anyone of the references and common general knowledge in the art. The feature of the solution having a pH in a range is a matter of experimentation and optimisation of parameters for a PSA in light of the disclosure of anyone of the references and common general knowledge in the art.
The features of the minimum recovery of the permeate as a percentage and turbidity are matters of experimentation and optimisation of parameters for a PSA in light of the disclosure of anyone of the references and common general knowledge in the art.
Furthermore, appended claims 1, 4-6, 14, 20 and 21 are obvious in light of the disclosure of the primary reference and common general knowledge in the art.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole (in claims 1-9, 11-12, 14-16, 18-19, 22-25 and 29-30) because the combined teaching of the references render the claimed invention as obvious. One of ordinary skill in the art would be motivated to combine the references because they are analogous art. Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Conclusion
10. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
Prosecution Insights