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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 3, the phrase "preferably" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those not preferred or not used in therapeutic apheresis), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Furthermore, the addition of the word "type" to an otherwise definite expression (e.g., microtubular) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). It is unclear what "type" was intended to convey.
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.
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 consider 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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20180093032 A1) in view of Sheriff et al. (US 20230090960 A1), and further in view of Storr et al. (US 20190247560 A1).
Regarding Claim 1, Smith discloses a targeted apheresis device ("targeted apheresis device" [0031]; FIG. 1) for removing a plurality of proinflammatory factors from a patient's blood or plasma ("remove pro-inflammatory cytokines" [0040-0045]);
wherein said device is composed of a cartridge ("apheresis cartridge" [0015]) containing multiple immobilized binding agents ("various binding agents or ligands can be immobilized" [0017]) that will specifically bind out Tumor Necrosis Factor (TNF) ("tumor necrosis factor (TNF)" [0040], [0044-0045]).
Smith fails to specify the multiple immobilized binding agents bind out C-Reactive Protein (CRP) and C1q component of complement. However, Sheriff teaches “an affinity chromatographic method for removing a substance” ([0036]) wherein the immobilized binding agents bind out C-Reactive Protein (CRP) (“compounds (ligands) are bound which have the property of specifically binding the target compound, in particular CRP” [0103]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Smith to incorporate the teachings of Sheriff to suitably remove CRP to limit the development of cardiovascular disease ([0005]).
Smith/Sheriff fails to specify the multiple immobilized binding agents bind out C1q component of complement. However, Storr teaches “a blood treatment device adapted to remove at least one human complement factor and/or its cleavage fragments from the blood or blood plasma of a patient” ([0018]) wherein the immobilized binding agents bind out C1q component of complement (“remove said complement factors or fragments thereof from the blood or blood plasma of a patient by immobilizing them on a matrix which is contacted with the said blood or blood plasma of the patient and wherein the matrix comprises a support and a ligand” ([0019]). Therefore, it would be obvious to modify Smith/Sheriff to suitably treat “a patient suffering from a complement factor related disease” ([0001]).
Regarding Claim 2, Smith discloses the binding agent is an antibody, or an aptamer, or a binding peptide ("antibodies, aptamers, peptides" [0006]).
Regarding Claim 3, Smith discloses the support matrix is microbeads, or a microporous membrane preferably of the microtubular type used in therapeutic apheresis ("membranes commonly used in conventional apheresis and their arrangement within a typical apheresis cartridge device are used to provide the support matrix" [0015-0016]).
Regarding Claim 4, Smith discloses the patient in need will receive one or more targeted apheresis treatments ("whole blood from a patient in need is passed thru an apheresis device containing these treated membranes the harmful substance in the blood will be bound out and removed from circulation while the cleaned blood is returned to the patient" [0028]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20180093032 A1) in view of Humes et al. (US 20090060890 A1), Sheriff et al. (US 20230090960 A1), and Storr et al. (US 20190247560 A1).
Regarding Claim 5, Smith discloses a targeted apheresis device ("targeted apheresis device" [0031]; FIG. 1) for removing a plurality of proinflammatory factors from a patient's blood ("remove pro-inflammatory cytokines" [0040-0045]);
wherein said device is composed of a cartridge ("apheresis cartridge" [0015]) containing: a plurality of immobilized binding agents ("various binding agents or ligands can be immobilized" [0017]) that will bind out: Tumor Necrosis Factor (TNF) ("tumor necrosis factor (TNF)" [0040], [0044-0045]).
Smith fails to specify the cartridge containing a leukocyte reduction filter. However, Humes teaches “systems, devices, and methods to treat and/or prevent inflammatory conditions” ([0003]) comprising a cartridge (“Cartridges” [0097]) containing a leukocyte reduction filter (“passageway region configured to sequester leukocytes” [0099]). Therefore, it would be obvious to modify Smith to suitably inhibit or deactivate inflammatory action and prevent “inflammatory diseases and conditions” ([0012]).
Smith/Humes fails to specify the multiple immobilized binding agents bind out C-Reactive Protein (CRP) and C1q component of complement. However, Sheriff teaches “an affinity chromatographic method for removing a substance” ([0036]) wherein the immobilized binding agents bind out C-Reactive Protein (CRP) (“compounds (ligands) are bound which have the property of specifically binding the target compound, in particular CRP” [0103]). Therefore, it would have been obvious to modify according to Sheriff to suitably remove CRP to limit the development of cardiovascular disease ([0005]).
Smith/Humes/Sheriff fails to specify the multiple immobilized binding agents bind out C1q component of complement. However, Storr teaches “a blood treatment device adapted to remove at least one human complement factor and/or its cleavage fragments from the blood or blood plasma of a patient” ([0018]) wherein the immobilized binding agents bind out C1q component of complement (“remove said complement factors or fragments thereof from the blood or blood plasma of a patient by immobilizing them on a matrix which is contacted with the said blood or blood plasma of the patient and wherein the matrix comprises a support and a ligand” ([0019]). Therefore, it would be obvious to modify Smith/Humes/Sheriff to suitably treat “a patient suffering from a complement factor related disease” ([0001]).
Regarding Claim 6, Smith discloses the patient in need will receive one or more targeted apheresis treatments ("whole blood from a patient in need is passed thru an apheresis device containing these treated membranes the harmful substance in the blood will be bound out and removed from circulation while the cleaned blood is returned to the patient" [0028]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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 E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781