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 Arguments
Applicant’s arguments, see pages 1-2, filed 07/21/2026, with respect to the rejection of claims 1-8 under 35 U.S.C. 103 as being unpatentable over Eliaz US Patent Application Publication 2023/0123338 in view of Fisher, Jr. et al. US Patent Application Publication 2023/0158222 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Eliaz US Patent Application Publication 2020/0085866.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eliaz US Patent Application Publication 2020/0085866.
As to claim 1, Eliaz teaches a method of treating sepsis in a mammal, comprising:
a) Identifying a mammalian patient in need of treatment for sepsis (Eliaz paras. 0024, claim 14),
b) Administering apheresis comprising selective withdrawal of galectin-3 (Gal-3) (paras.0006, 0023, 0029) where Eliaz discusses removing “active” gal-3 versus removing gal-3 in an inactive state (para. 0006). Eliaz teaches treatment can be varied depending on the patient, the severity of the condition and the rate of the mammalian patient’s expression of gal-3. Elias teaches ordinarily, treatment every two to four weeks is contemplated until the condition is resolved, but treatment may be daily where required, or at any frequency there between (Eliaz para. 0030).
Claim Rejections - 35 USC § 103
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 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 2-8 are rejected under 35 U.S.C. 103 as being unpatentable over Eliaz US Patent Application Publication 2020/0085866.
As to claims 2 and 3, Eliaz does not specifically teach the treatment period of time is at least three days or in the case of claim 3, five days, in which the patient receives the apheresis treatment at least once a day. Eliaz does teach the treatment period can be every two to four weeks or daily. Eliaz teaches daily treatments include one or more plasma exchange sessions in a given day, or continuous plasmapheresis over a multiple hour period in acute conditions. Eliaz teaches the treatment can be varied depending on the patient, the severity of the condition, and the rate of the mammalian patient’s expression of gal-3 (para. 0030). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the treatment protocol of Eliaz to have the treatment repeatedly administered for periods of time necessary to achieve the desired result.
As to claim 4, Eliaz does not specifically teach the mammalian patient exhibits acute kidney injury (AKI) associated with the sepsis. However, Eliaz does teach the binding of gal-3 by a plasmapheresis element that will remove it from circulation is an event that will aid medical conditions, such as kidney damage (Eliaz para. 0042). It would have been obvious to one having ordinary skill in the art to use the apheresis treatment of Eliaz on a patient exhibiting acute kidney injury associated with sepsis since Eliaz teaches a patient may find particular application in the treatment of chronic kidney infection and end stage renal disease (Eliaz para. 0054).
As to claim 5, Eliaz teaches a method of treating acute kidney injury (AKI) in a mammal (paras. 0042,0054), (see the rejection of claim 4, supra) in need of same, comprising:
a) Identifying a mammalian patient in need of treatment for AKI (Eliaz paras. 0011-0012, 0054)
b) Administering apheresis comprising selective withdrawal of Gal-3 (paras. paras.0006, 0023, 0028-0029) where Eliaz discusses removing “active” gal-3 versus removing gal-3 in an inactive state (para. 0006). Eliaz teaches treatment can be varied depending on the patient, the severity of the condition and the rate of the mammalian patient’s expression of gal-3. Elias teaches ordinarily, treatment every two to four weeks is contemplated until the condition is resolved, but treatment may be daily where required, or at any frequency there between (Eliaz para. 0030).
As to claim 6, treatment of the patient further comprises administration of at least one agent to the patient, wherein the agent is selected from the group consisting of metabolism regulators, immune reaction modifiers (Eliaz para. 0055), pharmaceuticals (Eliaz para. 0055) – where Eliaz teaches any drugs delivered to address an issue where gal-3 is contributing factor (para 0055), cytotoxic compounds, anti-microbial agents (Eliaz para. 0055), chelating agents and combinations thereof .
As to claim 7, treatment of the patient further comprises administration of an agent to the patient, wherein the agent is selected from the group consisting of metabolism regulators, immune reaction modifiers (Eliaz para. 0055), pharmaceuticals (Eliaz para. 0055) – where Eliaz teaches any drugs delivered to address an issue where gal-3 is contributing factor (para 0055), cytotoxic compounds, anti-microbial agents (Eliaz para. 0055), chelating agents and combinations thereof.
As to claim 8, treatment of the patient further comprises selective removal of at least one additional blood component selected from the group consisting of lipopolysaccharides (LPS), C-Reactive Protein, IL-4, IL-6, IL-1B, IL-10, TNF alpha (Eliaz paras. 0027, 0031, 0040), NF-kB, and combinations thereof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Swartjes et al. US 2022/0241484 and Tejedor Jorge et al. US 2020/0069623 are cited to show extracorporeal blood treatments for sepsis and/or for the treatment of sepsis-associated acute kidney injury (AKI).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
