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 .
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 1-8 are rejected 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.
As to claims 1 and 2, Eliaz teaches a method of treating sepsis in a mammal, comprising:
a) Identifying a mammalian patient in need of treatment for sepsis, b) Administering apheresis comprising selective withdrawal of galectin-3 (Gal-3) (paras. 0002, 0013-0015). Eliaz teaches a time course of changes in serum Gal-3 and serum IL-6 are established (para. 0020). However, Eliaz does not specifically teach the patient is treated repeatedly for a period of time sufficient to reduce the Gal-3 level in the blood.
Fisher teaches a method for treating infections (COVID-19) that reduce the likelihood of multiorgan failure reduce the likelihood of acute kidney disease, sepsis and/or other complications (Fisher, Jr. para. 0007). Fisher teaches the method may be repeated every day for 1 to 15 days (para. 0259-0261). 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 3, the period of time is at least five days – where Eliaz teaches a pre-specified 7-day endpoint (para. 0026).
As to claim 4, the mammalian patient exhibits acute kidney injury (AKI) associated with the sepsis (paras. 0020, claim 3).
As to claim 5, Eliaz teaches a method of treating acute kidney injury (AKI) in a mammal (para. 0030) in need of same, comprising:
a) Identifying a mammalian patient in need of treatment for AKI (para. 007), b) Administering apheresis comprising selective withdrawal of Gal-3 (para. 0002, claim 3) Eliaz teaches the reduction of the Gal-3 level in the blood of the mammalian patient (paras. 0008), but Eliaz does not specifically teach the patient is treated repeatedly for a period of time sufficient to reduce the Gal-3 level in the blood.
Fisher teaches a method for treating infections (COVID-19) that reduce the likelihood of multiorgan failure reduce the likelihood of acute kidney disease, sepsis and/or other complications (Fisher, Jr. para. 0007). Fisher teaches the method may be repeated every day for 1 to 15 days (para. 0259-0261). 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 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, pharmaceuticals (Eliaz para. 0016), cytotoxic compounds, anti-microbial agents, chelating agents and combinations thereof – where Eliaz teaches the use of pectin and other pharmaceuticals, which meets the broad limitation of a pharmaceutical (paras. 0009, 0017-0018).
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, pharmaceuticals, cytotoxic compounds, anti-microbial agents, chelating agents and combinations thereof– where Eliaz teaches the use of pectin and other pharmaceuticals, which meets the broad limitation of a pharmaceutical (paras. 0009, 017-0018).
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, NF-kB, and combinations thereof (Eliaz claim 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eliaz CA 2893690 is cited to show a procedure for the removal of serum gal-3 from circulation by plasmapheresis.
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
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