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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office on has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/25/2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-18, 20 and 22-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The application has not described how to treat an infectious disease in an animal or human with the claimed method across the scope of treating a n infectious disease in an animal or human. Although adequate description is given for treating infectious diseases that are treatable by hemodialysis or extracorporeal circulation, there is no description of how to use the claimed method across the scope of “an infectious disease in an animal or human.” In this therapy, functionalized superparamagnetic nanoparticles are mixed with a patient’s blood outside the body to target and bind specific pathogens, which are then physically extracted using a high-gradient magnetic field before returning the cleansed blood to the patient. However, pathogens that live and replicate inside the body's own cells (such as red or white blood cells) cannot be accessed by magnetic nanoparticles circulating in the blood plasma. Extracorporeal (outside-the-body) devices only filter the blood. They cannot remove pathogens that have walled themselves off in organs, tissues, or the nervous system. Further, magnetic separation relies on specific antibodies or proteins coating the nanoparticles to "catch" the pathogen. Viruses that constantly change their outer proteins make it nearly impossible for a single targeting mechanism to bind them., such as Examples: Influenza, common colds (Rhinoviruses), and rapidly evolving pandemic variants. There is no description of how to use the method to treat these infectious diseases and infectious disease across the scope of “an infectious disease in an animal or human,” other than those infectious diseases that are treatable by hemodialysis or extracorporeal circulation. Further regarding claim 23 and 24, these claims recite a low osmotic pressure treatment and a low osmotic pressure solution wherein the low osmotic pressure solution has “an osmotic pressure than that of the cell.” There is no disclosure in the application to support this limitation. It is not expressly stated in the application expresssy, nor is it supported through a representative number of examples.
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.
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 consoder 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.
Claims 15-18, 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0220617 to Yung in view of Chen (ACS Appl. Mater. Interfaces, 2017) in further view of Kang (Optimization of Pathogen Capture in Flowing Fluids with Magnetic Nanoparticles, Small 2015, 11, No. 42, 5657–5666) in further view of Bohmer (Removal of Cells from Body Fluids by Magnetic Separation in Batch and Continuous Mode: Influence of Bead Size, Concentration, and Contact Time, ACS Appl. Mater. Interfaces 2017, 9, 29571−29579). Chen teaches methods of treating an infectious disease in an animal or human, the method comprising introducing a sample from the animal or human to hemodialysis or extracorpeal circulation device for purposes of removing pathogenic material by use of a magnetic field, such as removing infectious influenza viruses (a systemic infectious agent) from fluids comprising the active steps of mixing magnetic nanoparticles coated by red blood cell membranes with the virus and extracting the virus using a magnetic field. (abstract; Figure 1; claims). Chen teaches that the methods for pathogen targeting and isolation can be used for treatment and diagnosis of disease threats (examples; claims). Yung further teaches dialysis like extracorporeal therapeutic devices comprising a series of channels that can allow fluids and magnetic particles to flow through them that will separate out the magnetic particles when a field is applied that can collect and flush the particles acting like an artificial spleen that can remove harmful pathogens like influenza viruses (abstract; paragraph 5 and 198).
Yung fails to teach using magnetic particles comprising a cell membrane capable of capturing pathogenic material as the magnetic particles in the devices, and further fails to teach wherein the magnetic particle has an average particle size of 100 to 300 nm, and further fails to teach “one magnetic particle invaginated within the cell membrane to form a vesicle.”
Chen teaches methods of removing infectious influenza viruses (a systemic infectious agent) from fluids comprising the active steps of mixing magnetic nanoparticles coated by red blood cell membranes with the virus and extracting the virus using a magnetic field (abstract; Figure 1). Chen teaches that the methods for pathogen targeting and isolation can be used for treatment and diagnosis of disease threats (abstract; conclusion) Chen teaches that the particles utilize cellular membrane coatings that provide for selective binding affinity to viral pathogens that form colloidally stable clusters with influenza viruses (abstract; conclusion).
Kang teaches magnetic nanoparticles with a size of 250 nm provide efficient magnetic separation in solution for purpose of capturing pathogens in flowing fluids with magnetic nanoparticles (Title, Abstract, Conclusion).
Bohmer teaches magnetic particles for separation of diseased cells wherein at least “one magnetic particle is encapsulated (invaginated) within the cell membrane to form a vesicle” (abstract; Materials and Methods).
It would have been obvious one of ordinary skill in the art at the time the invention was made to use magnetic nanoparticles in the method of Chen for purposes of capturing the influenza virus particle from samples taken from animals and/or humans. The motivation for this would be to improve the capture of virus particles during treatment by using the improved magnetic particles of Chen that mimic natural cells allowing for binding to viruses and their removal. One of ordinary skill in the art would have had a predictable expectation of success in making this combination given that all of the art is directed to removing pathogens from the blood using magnetic particles removed by magnetic fields and Chen teaches an improved magnetic particle useful in just such techniques. It would have been further obvious to optimize the present particle size to improve the efficacy of the formulation for removing pathogenic material from a patient. In this way, one would find the present range of 100 nm to 300 nm through routine experimentation. The prior art provides sufficient guidance to this end as Kang teaches magnetic nanoparticles with a size of 250 nm provide efficient magnetic separation in solution for purpose of capturing pathogens in flowing fluids with magnetic nanoparticles, which overlaps with the present range. It would have been further obvious to modify the method to afford at least “one magnetic particle is invaginated within the cell membrane to form a vesicle, the motivation for this would have been to protect the particles from immune clearance and enzyme degradation. Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the references do not teach invagination within the cell membrane to form a vesicle, the examiner’s response is that in the rejection as now presented relies on Bohmer, which renders obvious this limitation for the reasons set forth above.
Conclusion
This action is non-final. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
July 6, 2026
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