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 Amendments/Arguments
Applicant’s arguments, filed 9 December 2025, with respect to the rejections under 35 USC 112 as well as Drawing Objections have been fully considered and are persuasive. The rejections and objections have been withdrawn; the Examiner regrets the error.
Applicant’s arguments, filed 9 December 2025, with respect to the rejections of the pending claims, as amended, over Davies have been fully considered but are not persuasive. Davies discloses a step of providing nonautologous albumin to the patient (see claim 12, rejections below).
Applicant argues that the Office failed to identify any portion of Davies that discloses the “use of albumin that does not derive from the individual to the blood of the individual….” The Examiner notes that such a rejection was provided in the prior Office action for (now canceled) claim 27.
Applicant argues that there is no teaching or suggestion in Davies that the method claimed by Davies could treat patients with cytokine storm syndrome or COVID-19. Davies specifically teaches that the method treats patients with liver disease, but not other pathologies (see column 13, liens 10-24). DIALIVE discloses the use of a dialysis system to restore liver function by taking out diseased albumin and infuses fresh, functional albumin, targeting inflammation and improving survival rates. Tisoncik discloses that a “cytokine storm,” perhaps induced by a SARS-CoV infection, may cause organ dysfunction. Taken together, the references suggest using a liver dialysis system with albumin replacement to treat inflammation that may be caused by a cytokine storm or a SARS-CoV infection.
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.
Claims 1-9, 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,480,607 to Davies et al in view EASL,1 further in view of Tisoncik2.
In the specification and figures, Davies discloses the method as claimed by Applicant. With regard to claims 1, 21-25, Davies discloses a method of treating a patient comprising selectively removing albumin from the blood of an individual, selectively removing endotoxin from the blood of an individual, wherein the albumin removal may be via dialysis using at least a 50 kDa pore membrane, and introducing albumin the blood of the individual, wherein the introduced albumin is nonautologous (see column 1, lines 52-55, column 6, lines 60-67, column 7, lines 8-16, claim 12). The step of selecting a patient based on their current condition (see also claims 23-26) is a mental step performed by a practitioner. As such, the selection step is not eligible for patent protection and does not patentably distinguish the claim from the cited prior art.
Nonetheless, EASL teaches that albumin infusion therapy is beneficial for reducing liver inflammation. Tisoncik discloses that organ failure may result from inflammation evoked by a cytokine storm that may be associated with a SARS-CoV infection. It would have been obvious to a person having ordinary skill in the art to use the method disclosed by Daniels to treat alternate pathologies giving rise to various inflammation conditions as taught by EASL. To that end, as taught by Tisoncik it was known that cytokine storms and SARS-CoV infections may induce inflammation. That is, as evidenced by the prior art, a person of ordinary skill in the art, upon noticing inflammation, would have been motivated to look to known inflammation-reducing treatments, such as the dialysis treatment disclosed by EASL with the filter pore size disclosed by Daniels. Taken together, the references suggest the method claimed by Applicant.
With regard to claim 2, Davies discloses that the albumin may be removed by membrane dialysis, while the endotoxins may be removed via affinity binding (see column 6, lines 60-67, column 9, lines 8-25).
With regard to claim 4, Davies discloses that the method includes the removal of albumin-bound toxins (see column 4, lines 50-53).
With regard to claim 5, Davies discloses the use of a solid support capable of selectively binding albumin (see column 6, lines 41-55).
With regard to claim 6, Davies discloses the use of a solid support capable of selectively binding endotoxins (see column 9, lines 50-63).
With regard to claims 7-9, Davies claims an apparatus and an ex vivo method that selectively removes albumin, endotoxins, and means for supplying allogenic pharmaceutical grade albumin, where other components are returned to the patient (see claims 1, 4, 12, 17, column 12, lines 48-65).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 8,480,607 to Davies et al in view of US 2020/0069860 to Rammo et al.
In the specification and figures, Davies discloses the method substantially as claimed by Applicant (see rejections above). With regard to claim3, Davies does not disclose a step of cytokine removal. However, Rammo discloses a multi-component blood filtration system that comprises at least an adsorber, and a dialysis device, wherein the adsorber may be used for cytokine removal (see all FIGS, ¶0034, 0087, 0160). Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
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 LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 18 December 2025
1 European Association for the Study of the Liver (EASL) announcement of ALIVER liver dialysis apparatus in Amsterdam in 2017. Prior art provided by Applicant in IDS filed 20230206.
2 Tisoncik JR, Korth MJ, Simmons CP, Farrar J, Martin TR, Katze MG. Into the eye of the cytokine storm. Microbiol Mol Biol Rev. 2012 Mar;76(1):16-32. doi: 10.1128/MMBR.05015-11. PMID: 22390970; PMCID: PMC3294426.
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