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.
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) 1-2 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (US 20160082177 A1) in view of Kwon et al. (non-patent literature – Circulating mitochondrial N-formyl peptides contribute to secondary nosocomial infection in patients with septic shock)
Regarding claim 1, Ward discloses s blood perfusion device (100, fig. 1), comprising: a blood inlet (150) configured to allow blood to flow into the device (para. [0044, 0081]); an adsorption medium (110, para. [0044, 0051]) comprising an antibody (para. [0051]); and a blood outlet (160) configured to allow blood to flow out of the device (para. [0044, 0081]).
However, Ward fails to disclose an anti-mitochondrial N-formyl peptides antibody (anti- mtFP antibody).
Kwon demonstrates the principle that removing mtFPs is beneficial and desensitizing or eliminating circulating mtFPs before secondary infection can occur can be a therapeutic strategy to reduce the development of secondary infections (page 7 right column para. 5 – page 9 left column para. 1); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ward and use an antibody that specifically targets mtFPs, because doing so is disclosed by Kwon to be essential in reducing secondary infections (page 7 right column para. 5 – page 9 left column para. 1). Ward teaches an adsorption medium that is coated with a non-specific antibody, so incorporating an antibody with a clear benefit as shown in Kwon, would yield a reasonable expectation of success.
Regarding claim 2, the combination of Ward and Kwon discloses the device of claim 1. However, Ward fails to disclose wherein the blood perfusion device suppresses the occurrence of secondary infection in hospital.
Kwon teaches wherein the blood perfusion device suppresses the occurrence of secondary infection in hospital (page 7 right column para. 5 – page 9 left column para. 1).
Kwon demonstrates the principle that removing mtFPs is beneficial and desensitizing or eliminating circulating mtFPs before secondary infection can occur can be a therapeutic strategy to reduce the development of secondary infections (page 7 right column para. 5 – page 9 left column para. 1); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ward and use an antibody as taught by Kwon to reduce secondary infections (page 7 right column para. 5 – page 9 left column para. 1). Ward teaches an adsorption medium that is coated with a non-specific antibody, so incorporating an antibody with a clear benefit as shown in Kwon, would yield a reasonable expectation of success.
Regarding claim 7, the combination of Ward and Kwon discloses the device of claim 1. Ward discloses wherein the adsorption medium (110) has an antibody attached or coated on a surface thereof (para. [0044, 0081]).
However, Ward fails to disclose an anti-mtFP antibody.
Kwon demonstrates the principle that removing mtFPs is beneficial and desensitizing or eliminating circulating mtFPs before secondary infection can occur can be a therapeutic strategy to reduce the development of secondary infections (page 7 right column para. 5 – page 9 left column para. 1); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ward and use an antibody as taught by Kwon to reduce secondary infections (page 7 right column para. 5 – page 9 left column para. 1). Ward teaches an adsorption medium that is coated with a non-specific antibody, so incorporating an antibody with a clear benefit as shown in Kwon, would yield a reasonable expectation of success.
Regarding claim 8, the combination of Ward and Kwon discloses the device of claim 1. Ward further discloses wherein the adsorption medium (110) is at least one selected from the group consisting of fiber form, bead form, film form, and hollow-fiber form (para. [0053, 0058-0059]).
Allowable Subject Matter
Claims 9-10 are allowed.
Claims 4-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
There is no art alone or in combination that discloses wherein the mtFP is at least one selected from the group consisting of mitochondrial NADH-ubiquinone oxidoreductase chain 6 (MT-ND6), MT-ND3, MT-ND4, MT-ND5, and mitochondrial cytochrome c oxidase 1 (MT-COX1). Nor prior art that discloses wherein the device comprises leukotriene B4 and wherein the adsorption medium comprises the anti-mtFP antibody at a concentration of 0.5 pg/mL to 20.0 pg/mL. Kwon does not disclose anti-mtFP concentrations nor specific types of anti-mtFPs, and it would not have been obvious to make a modification without prior art to rely on or a motivation to do so.
Further, claims 9 and 10 disclose a method for reducing secondary infections with the use of the anti-mtFP, and the prior art does not have sufficient disclosure to read on the claimed limitations without relying on hindsight or support for such a modification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 22 January 2026