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 1-20 are pending and currently under consideration for patentability.
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(s) 1-6, 9 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tullis (US 20110218512 A1).
Regarding Claim 1, Tullis teaches a method for treating a viral infection in an individual in need thereof, comprising:
providing an extracorporeal adsorptive viral target removal device (paragraph [0070]), said device having:
a housing (102);
a hollow fiber plasma filter having a plurality of pores sized between 200-2000 Angstroms (paragraph [0070]: 100 to 200 nm) and an adsorbent positioned inside the housing and outside the fiber in an extra lumen space (paragraph [0071 ]);
filtering the plasma of an individual in need thereof through said adsorptive viral target removal device (paragraph [0014]);
wherein said filtering causes a viral target to pass through said pores (paragraph [0014][0070]);
contacting said viral target with said adsorbent (paragraph [0014]);
wherein said viral target is bound to said adsorbent; and
capturing said viral target in said adsorbent (paragraph [0014]).
Regarding Claim 2, Tullis teaches the method of Claim 1. Tullus further teaches wherein the capture of said viral target prevents the viral target from reentering circulation (paragraph [0070]).
Regarding Claim 3, Tullis teaches the method of Claim 1. Tullis further teaches wherein said viral target is selected from the group consisting of a viral pathogen, viral protein, viral exosome, viral particle and combinations thereof (paragraph [0041]).
Regarding Claim 4, Tullis teaches the method of Claim 1. Tullis further teaches wherein said adsorbent is selected from the group consisting of activated carbon (paragraph [0111]), non-ionic exchange resin and ion exchange resin.
Regarding Claim 5, Tullis teaches the method of Claim 1. Tullis further teaches wherein said viral target is a bloodborne virus (paragraph [0083][0123]).
Regarding Claim 6, Tullis teaches the method of Claim 1. Tullis further teaches wherein said virus is selected from the group consisting of HIV, dengue virus, West Nile virus, rubella, measles, cytomegalovirus, Epstein-Barr virus, hepatitis B virus, hepatitis C virus, hepatitis E virus, varicella-zoster virus, chikungunya virus, zika virus, and human T-lymphotropic virus [0054].
Regarding Claim 9, Tullis teaches the method of Claim 4. Tullis further teaches wherein said activated carbon is selected from the group consisting of coated coconut shell granule, uncoated coconut shell granule, and synthetic charcoal (paragraph [0113]).
Regarding Claim 16, Tullis teaches the method of Claim 1. Tullis further teaches administering an antiviral agent selected from the group consisting of an immunostimulator, immunomodulator, a nucleoside antiviral agent, a nucleotide antiviral agent, a protease inhibitor, inosine 5′-monophosphate dehydrogenase (IMPDH) inhibitor, a viral entry inhibitor, a viral maturation inhibitor, a viral uncoating inhibitor, an integrase inhibitor, viral enzyme inhibitor, an anti-sense molecule, a ribozyme antiviral agent, a nanoviricide, interferon, antibody and combinations thereof (paragraph [0033]).
Regarding Claim 17, Tullis teaches a kit for treating a viral infection in an individual in need thereof, the kit comprising: a broad spectrum extracorporeal blood purification device (paragraph [0070]), comprising
a housing (102);
a hollow fiber filter disposed within said housing, said filter comprising a plurality of pore sized and dimensioned to permit passage of viral targets (paragraph [0014]) having a diameter between about 20 nm and 200 nm (paragraph [0070]: 100 to 200 nm); and
at least one adsorption component positioned inside the housing and outside the hollow fiber in an extra-lumen space (paragraph [0014]).
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.
Claim(s) 7, 8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tullis (US 20110218512 A1).
Regarding Claim 7, Tullis teaches the method of Claim 5. Tullis fails to explicitely teach wherein said virus is selected from the group consisting of arenavirus, flavivirus, nairovirus, hantavirus, and phenuivirus. However Tullis does teach “the methods disclosed herein can be applied to a wide spectrum of viruses, for example, any virus that can bind lectin is applicable” (paragraph [0035]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Tullis wherein said virus is selected from the group consisting of arenavirus, flavivirus, nairovirus, hantavirus, and phenuivirus.
Regarding Claim 8, Tullis teaches the method of Claim 5. Tullis fails to explicitly teach wherein said virus is a coronavirus. However Tullis does teach “the methods disclosed herein can be applied to a wide spectrum of viruses, for example, any virus that can bind lectin is applicable” (paragraph [0035]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Tullis wherein said virus is a coronavirus.
Regarding Claim 19, Tullis teaches kit of Claim 17. Tullis fails to explicitly teach wherein said hollow fiber filter has an average pore size of 2000 Angstroms. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have said hollow fiber filter has an average pore size of 2000 Angstroms in order to fit the particular procedure being done since this claimed dimension of the average pore size is non-critical Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0007 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim(s) 10-15, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tullis (US) in view of Roberts (US 20210030942 A1).
Regarding Claim 10, Tullis teaches the method of Claim 4. Tullis fails to explicitly wherein the adsorbent is at least one ion exchange resin or non-ionic exchange resin. Roberts teaches a process of filtering blood wherein the adsorbent is at least one ion exchange resin or non-ionic exchange resin (paragraph [0012-0013]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein the adsorbent is at least one ion exchange resin or non-ionic exchange resin, similar to Roberts, in order to have a specific pore size.
Regarding Claim 11, Tullis teaches the method of Claim 4. Tullis fails to explicitly wherein said at least one non-ionic exchange resin is a non-ionic aliphatic ester resins, non-ionic polystyrene divinyl benzene resins, or combinations thereof. Roberts teaches a process of filtering blood wherein said at least one non-ionic exchange resin is a non-ionic aliphatic ester resins, non-ionic polystyrene divinyl benzene resins, or combinations thereof (paragraph [0012-0013]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein said at least one non-ionic exchange resin is a non-ionic aliphatic ester resins, non-ionic polystyrene divinyl benzene resins, or combinations thereof, similar to Roberts, in order to have a specific pore size.
Regarding Claim 12, Tullis teaches the method of Claim 11. Tullis fails to explicitly wherein at least one of said non-ionic aliphatic ester resins has an average surface area of approximately 500 m2/g, an average pore size of approximately 300-600 Angstroms, and a mean particle diameter of 560 microns. Roberts teaches a process of filtering blood wherein at least one of said non-ionic aliphatic ester resins has an average surface area of approximately 500 m2/g, an average pore size of approximately 300-600 Angstroms, and a mean particle diameter of 560 microns. (paragraph [0012-0013]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein at least one of said non-ionic aliphatic ester resins has an average surface area of approximately 500 m2/g, an average pore size of approximately 300-600 Angstroms, and a mean particle diameter of 560 microns, similar to Roberts, in order to have a specific pore size.
Regarding Claim 13, Tullis teaches the method of Claim 11. Tullis fails to explicitly wherein at least one of said non-ionic polystyrene divinyl benzene resins has an average surface area of approximately 700 m2/g, and an average pore size of 300 Angstroms, and a mean particle diameter from approximately 35 microns to approximately 120 microns.. Roberts teaches a process of filtering blood wherein at least one of said non-ionic polystyrene divinyl benzene resins has an average surface area of approximately 700 m2/g, and an average pore size of 300 Angstroms, and a mean particle diameter from approximately 35 microns to approximately 120 microns.. (paragraph [0012-0013]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein at least one of said non-ionic polystyrene divinyl benzene resins has an average surface area of approximately 700 m2/g, and an average pore size of 300 Angstroms, and a mean particle diameter from approximately 35 microns to approximately 120 microns, similar to Roberts, in order to have a specific pore size.
Regarding Claim 14, Tullis teaches the method of Claim 11. Tullis fails to explicitly wherein at least one of said non-ionic polystyrene divinyl benzene resins has an average surface area of approximately 600 m2/g, an average pore size of 100-400 Angstroms, and a mean particle diameter from approximately 300 microns to approximately 500 microns. Roberts teaches a process of filtering blood wherein at least one of said non-ionic polystyrene divinyl benzene resins has an average surface area of approximately 600 m2/g, an average pore size of 100-400 Angstroms, and a mean particle diameter from approximately 300 microns to approximately 500 microns (paragraph [0012-0013]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein at least one of said non-ionic polystyrene divinyl benzene resins has an average surface area of approximately 600 m2/g, an average pore size of 100-400 Angstroms, and a mean particle diameter from approximately 300 microns to approximately 500 microns, similar to Roberts, in order to have a specific pore size.
Regarding Claim 15, Tullis teaches the method of Claim 11. Tullis fails to wherein the activated carbon has a pore size distribution of a Micropore region of less than 100 Angstroms, a Mesopore region of between 100 and 1,000 Angstroms, and a Macropore region of greater than 1,000 Angstroms. Roberts teaches a process of filtering blood wherein the activated carbon has a pore size distribution of a Micropore region of less than 100 Angstroms, a Mesopore region of between 100 and 1,000 Angstroms, and a Macropore region of greater than 1,000 Angstroms (paragraph [0014]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein the activated carbon has a pore size distribution of a Micropore region of less than 100 Angstroms, a Mesopore region of between 100 and 1,000 Angstroms, and a Macropore region of greater than 1,000 Angstroms, similar to Roberts, in order to have a specific pore size.
Regarding Claim 18, Tullis teaches the method of Claim 17. Tullis fails to wherein further comprising an accessory selected from the group consisting of a blood access catheter, a blood tubing set, a blood connector, and combinations thereof. Roberts teaches wherein further comprising an accessory selected from the group consisting of a blood access catheter (paragraph [0066]), a blood tubing set (extracorporeal lines), a blood connector (claim 20), and combinations thereof. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Tullis to have an accessory selected from the group consisting of a blood access catheter, a blood tubing set, a blood connector, and combinations thereof, similar to Roberts to connect to the extracorporeal machine.
Regarding Claim 20, Tullis teaches the kit of Claim 17. Tullis fails to explicitly wherein said adsorption component is selected from the group consisting of activated carbon, non-ionic exchange resin and ion exchange resin. Roberts teaches a process of filtering blood wherein the adsorbent is at least one ion exchange resin or non-ionic exchange resin (paragraph [0012-0013]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent of Tullis wherein the adsorbent is at least one ion exchange resin or non-ionic exchange resin, similar to Roberts, in order to have a specific pore size.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20150328387 A2, US 20110009796 A1, US 20050281809 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights