DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 11/14/2025 have been received and entered into the case. Claims 2, 4, 7-8, 10-13, 16-17, 20-22, 24-34, 36-37, 39, 41-43, 45-52, 54-61, 63-82, 84-92, and 94-106 have been canceled. Claims 1, 3, 5-6, 9, 14-15, 18-19, 23, 35, 38, 40, 44, 53, 62, 83, and 93 are pending, Claims 5-6, 9, 14-15, 18-19, 38, 40, 44, 53, 62, 83, and 93 have been withdrawn, and Claims 1, 3, 23, and 35 have been considered on the merits, insofar as they read on the elected species of polyethylene glycol. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 1, 3, 23, and 35 under 35 U.S.C. 103 as being unpatentable over Burnouf et al (WO 2009/087560 A1; 7/16/2009.) in view of Hosseini et al (Iran J Biotech. 2014;12(3):e1018.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 30 under 35 U.S.C. 103 as being unpatentable over Burnouf et al (WO 2009/087560 A1; 7/16/2009.) in view of Hosseini et al (Iran J Biotech. 2014;12(3):e1018.) are withdrawn in view of applicant’s amendments – Claim 30 has been canceled.
Claim Objections
Claim 1 is objected to because of the following informalities: the recitation of “plasma” on line 3 is suggested to read “a plasma”. Appropriate correction is required.
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 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 of this title, 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.
Claims 1, 3, 23, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Fahmy et al (WO 2018/091713 A1; 5/24/2018.) in view of Hosseini et al (Iran J Biotech. 2014;12(3):e1018.).
The instant claims recite a method to remove fibrinogen from plasma comprising the steps of: collecting plasma from a blood sample of a human donor or from already collected blood stored in a blood bank by apheresis; incubating the plasma with a fibrinogen-selective binding agent; centrifuging the incubated plasma with the fibrinogen-selective binding agent to produce a processed plasma; using sonication or a hypotonic buffer solution to lyse platelets contained in the processed plasma; centrifuging the collected platelets to form a platelet pellet; removing said binding agent with bound fibrinogen from said platelet-containing processed plasma; and re-suspending the platelet pellet in the processed plasma.
Fahmy teaches a method for preparing a growth factors containing platelet releasate (Title), wherein the method is intended for the preparation of fibrinogen depleted blood platelet releasate rich in growth factors from mammalian platelet concentrate which could be human platelets (p.17 line 5-6), comprising: subjecting a platelet concentrate to an activation step by contacting it with an activating agent including thrombin (a fibrinogen-selective binding agent) to provide a fluid platelets releaste (p.6 line 18-19, p.7 line 12-13 & 29), which can be done chemically, mechanically, or sonication, or by lyses (p.13 line 28), wherein the platelet concentrate include blood plasma derived from human, a pool of allogenic fluids which originate from several different subjects, e.g., from apheresis, or routinely prepared at blood banks (p.12 line 10-16), and Example 1 teaches obtaining a platelet rich concentrate from human (p.19 line 26-27), incubating the platelet concentrate with thrombin (p.19 line 30), and centrifuging the thrombin treated platelet concentrate (p.20 line 4); subjecting the fluid platelet releasate to a fibrinogen concentration reduction step, and recovering a fibrinogen depleted fluid platelet releasate for further use (p.6 line 22-24, p.8 line 7-8 & 21). The platelet concentrate is maintained in plasma or in a mixture of plasma and an additive solution (p.12 line 25-26). The platelet concentrate comprises a pool of platelets which originate from different mammalian subjects (p.19 line 20-22). The platelet releasate is stored for use in emergency situations for treating wounds (p.17 line 29-31).
Fahmy does not explicitly teach removing binding agent with bound fibrinogen from platelet-containing processed plasma, and re-suspending platelet pellet in the processed plasma (claim 1), wherein the fibrinogen-selective binding agent is polyethylene glycol (claim 35).
However, Fahmy does teach the method is intended for the preparation of fibrinogen depleted blood platelet releasate, wherein the platelet concentrate is maintained in plasma or in a mixture of plasma and an additive solution (p.12 line 25-26), and it is advisable to remove the fibrinogen since it may give rise to the formation of a semisolid gel which could cause a nuisance when blood plasma that has been enriched with platelets, is further used for treatment (p.8 line 12-18). Hosseini teaches fractionation of human plasma by polyethylene glycol (Title) comprising incubating human plasma with polyethylene glycol (PEG) followed by centrifugation (p.83 col left – para 3-4), wherein PEG is used to precipitate fibrinogen (Table 1), and using PEG allows working above zero temperature without denaturation of protein (p.84 col left – last para).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate polyethylene glycol (PEG) as a fibrinogen-selective binding agent, remove the binding agent with bound fibrinogen from a platelet-containing processed plasma, and re-suspending platelet pellet in the processed plasma, since Fahmy discloses a method that is intended for the preparation of fibrinogen depleted blood platelet releasate comprises incubating a plasma with a fibrinogen-selective binding agent, wherein the platelet concentrate is maintained in plasma or in a mixture of plasma and an additive solution, and it is advisable to remove the fibrinogen since it may give rise to the formation of a semisolid gel which could cause a nuisance when blood plasma that has been enriched with platelets, and Hosseini discloses that PEG is used to remove fibrinogen, and that PEG allows working above zero temperature without denaturation of protein. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate polyethylene glycol (PEG) as a fibrinogen-selective binding agent, remove the binding agent with bound fibrinogen from a platelet-containing processed plasma, and re-suspending platelet pellet in the processed plasma, with a reasonable expectation of success.
Response to Arguments
Applicant argues that claim 1, as amended, is not obvious based on the teachings of Burnouf et al. (WO 2009/087560A1) in view of Hosseini et al. (Iran J Biotech (2014), 12(3):1018). However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759