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 .
Status of Claims
Claims 1 and 3-7 are currently pending. Claim 2 is currently cancelled. Claims 1 and 3-4 have been amended. No new subject matter is added.
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.
Claims 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eliaz (US 20160279314 A1).
Regarding Claim 4, Eliaz teaches a method of treating a mammal with immunotherapy (a system and method for the practice of apheresis employs modules in the system which can be selected for a particular patient to treat particular situations or combinations of difficulties, Abstract; apheresis in the treatment of a variety of mammalian situations, see Paragraph [0007]; use of this new apheresis capability to develop/and use in conjunction with existing immune therapies... such as CAR-T genetically engineered cell therapy, see Paragraph [0025]), comprising
administering apheresis to said mammal to withdraw some portion of the blood of said mammal, selectively withdrawing an agent from said portion of said blood (the blood in such an embodiment is withdrawn and pumped by pump 1006 from mammal 1002... the whole blood may be treated as one unit. The blood passes through module 1008... comprising an opening through which the blood or plasma is led which comprises a Gal-3 Ga binding molecule the blood or plasma is exposed to; the molecule, an antibody, antibody fragment, peptide or polysaccharide adapted to selectively bind Gal-3, binds to Gal-3 as the blood passes through, see Paragraph [0349]; a system which reduces Gal-3 concentrations while simultaneously administering other treatments... either removal or addition of other agents, see Paragraph [0015]; the agents... may be effectively removed through the use of this invention, see Paragraph [0062]), and
returning the blood to said patient following said selective withdrawal apheresis (showing a measurably reduced amount of Gal-3 after it has passed through the system and is returned to the mammal, see Paragraph [0349]),
wherein said agent is selected from the group consisting of PD-1, PDL-1, tumor infiltrating lymphocytes, T- Cells for chimeric antigen receptor modification and stem cells for modification and return (one example is the... harvesting stem cells bearing a particular signature for modification for later return to the individual, see Paragraph [0086]).
Regarding Claim 5, Eliaz further teaches wherein said treatment is augmented by selective withdrawal of at least one of galectin-3, IL1B, IL-6, IL-4, IL-8, TNF Alpha, NF Kappa B and mixtures thereof (a system which reduces Gal-3 concentrations while simultaneously administering other treatments... either removal or addition of other agents, see Paragraph [0015]).
Regarding Claim 6, Eliaz further teaches wherein said immunotherapy further comprises administration of an anti-cancer agent effective in the treatment of one or more types of cancer (Apheresis pre-treatment... prior to chemotherapy... or during treatment...for example during chemotherapy, see Paragraph [0107]).
Regarding Claim 7, Eliaz further teaches wherein said administration of said anti-cancer agent is achieved at or near the same time as said apheresis (apheresis... during treatment... for example during chemotherapy, see Paragraph [0107]).
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Eliaz (US 20160279314 A1) in view of Swartjes et al. (WO 2020178420), hereinafter referred to as “Swartjes”.
Regarding Claim 1, Eliaz teaches a method of conducting whole blood apheresis (a system and method for the practice of apheresis, see Abstract; a new approach to apheresis, including treatment of whole blood without separation, see Paragraph [0086]),
wherein blood is diverted from a mammalian patient to an apheresis device to treat sepsis, wherein galectin-3 is selectively withdrawn from the blood of said patient (the blood In such an embodiment is withdrawn...from mammal...an opening through which the blood or plasma is led which comprises a Gal-3 binding molecule the blood or plasma is exposed to; the molecule, an antibody, antibody fragment, peptide or polysaccharide adapted to selectively bind Gal-3, binds to Gal-3 as the blood passes through, showing a measurably reduced amount of Gal-3 after it has passed through the system and is returned to the mammal; reductions on the order of...even 60% of circulating Gal-3 may be affected, see Paragraph [0349]), and
said blood is returned to said patient following selective withdrawal without the blood being separated (a new approach to apheresis, including...treatment of whole blood without separation, see Paragraph (0086]; Whole Blood Filtering Systems....with use of unseparated whole blood, specific cell types can be removed or treated as well as modulation of blood borne proteins and other factors, see Paragraph [0110]; apheresis to selectively remove Gal-3... removal can be effected by removal from whole blood... by even a limited percentage... a significant improvement in both acute and chronic inflammation can be achieved, see Paragraph [0349]).
However, Eliaz does not explicitly disclose wherein said method is used to treat a patient suffering from sepsis.
Swartjes teaches an extracorporeal blood circuit comprising a blood treatment device (see Abstract) wherein said method is used to treat a patient suffering from sepsis (the blood treatment device is an adsorption cartridge comprising a matrix, to which AP is immobilized, and is perfused with whole blood, pg. 6, ln 23-24; alkaline phosphatase... assisted continuous renal replacement therapy... to treat... sepsis-associated acute kidney injury, pg. 1, ln. 6-8).
Eliaz and Swartjes are analogous art because both disclose a blood treatment device for apheresis.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of Eliaz and further include a treatment for sepsis, as taught by Swartjes. Swartjes teaches it would be beneficial for the purpose of performing whole blood apheresis to remove unwanted substances from a patient's body (see pg. 16, ln. 14-16, 22).
Regarding Claim 3, Eliaz teaches all of the limitations as discussed above in claim 1 and Eliaz further teaches said method includes selective withdrawal of galectin-3 from said patient (the blood In such an embodiment is withdrawn...from mammal...an opening through which the blood or plasma is led which comprises a Gal-3 binding molecule the blood or plasma is exposed to; the molecule, an antibody, antibody fragment, peptide or polysaccharide adapted to selectively bind Gal-3, binds to Gal-3 as the blood passes through, showing a measurably reduced amount of Gal-3 after it has passed through the system and is returned to the mammal; reductions on the order of...even 60% of circulating Gal-3 may be affected, see Paragraph [0349]). However, Eliaz does not explicitly disclose wherein said method is used to treat a patient suffering from sepsis.
Swartjes teaches an extracorporeal blood circuit comprising a blood treatment device (see Abstract) wherein said method is used to treat a patient suffering from acute kidney injury (the blood treatment device is an adsorption cartridge comprising a matrix, to which AP is immobilized, and is perfused with whole blood, pg. 6, ln 23-24; alkaline phosphatase... assisted continuous renal replacement therapy... to treat... sepsis-associated acute kidney injury, pg. 1, ln. 6-8).
Eliaz and Swartjes are analogous art because both disclose a blood treatment device for apheresis.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of Eliaz and further include a treatment for sepsis, as taught by Swartjes. Swartjes teaches it would be beneficial for the purpose of performing whole blood apheresis to remove unwanted substances from a patient's body (see pg. 16, ln. 14-16, 22).
Response to Arguments
Applicant's arguments filed 08/28/2025 have been fully considered but they are not persuasive.
Specifically, applicant argues in that Eliaz in view of Swartjes would not teach one skill in the art a method that calls for apheresis to treat sepsis by selectively withdrawing Galectin-3. The applicant states that Swartjes specially calls for the use of a very specific resin filter or cartridge that is not effective in withdrawing Galectin-3.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., how galectin-3 is specifically withdrawn) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, Eliaz teaches the withdrawal of Galectin-3 and Swartjes does not need to teach the withdrawal of Galectin-3, but rather just how a similar apheresis device that also withdraws a target blood component can be used to treat sepsis. Therefore, Claim 1 would still be read by Eliaz in view of Swartjes.
Specifically, applicant argues in claim 4 that the target for withdrawal identified in Eliaz does not include one of the groups of PD-1, PDL-1, tumor infiltrating lymphocytes, T-Cells for chimeric antigen receptor modification and stem cells for modification and return.
The examiner respectfully disagrees with the applicant the Eliaz fails to include one of the groups recited. As described in Paragraph [0086], Eliaz suggest that the targets and/or additives are specific, or require a particular combination for a particular individual, it may be advantageous to design specific filter cartridges for that individual. One example is harvesting stem cells bearing a particular signature for modification for later return to the individual to achieve tissue growth. Therefore, Eliaz does suggest one of the groups recited and would read on claim 4.
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.
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/E.R./ (01/29/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781