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 102 and § 103
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.
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.
Claim(s) 1, 4-11 and 13 are rejected under 35 U.S.C. 102(a1) as anticipated by, or in the alternative, under 35 UCS 103 as unpatentable over Patel et al., (US 2020/0147289.)
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Patel teaches a method of plasmapheresis, in which blood drawn from a donor is mixed with an anticoagulant and then separated to its components, to collect plasma and re-infuse the HCT back to the donor. Blood is mixed with AC at the base of the phlebotomy needle (36) from AC supply bag and pump (54.) The blood-AC mixture is separated into plasma and HCT in separator (14) using pump (56.) Plasma collects in container (28). HCT collects in separation chamber (reservoir 32,) which is then reinfused to the donor. Monitoring various flows, such as AC, plasma and HCT – see [0043]
Patel uses an equation similar to that of applicant’s for calculating the Vac – see equation 7 in [0049]. Paragraphs [0016], [0017] and [0020] teach calculating Vac based on the anticoagulation ratio calculated based on Hct or as a modified FDA nomogram. In [0048], Patel clearly teaches that plasma collected is under the nomogram and based on patient’s Hct. Even though Patel in specified examples of 44% Hct starts with ACR of 16, all these “aspects” of the method described by Patel shows Vac being depended on the Hct of the patient, and the equation (7) used for ACR is also dependent on Hct. Contrary to applicant’s arguments on the presumption that the ACR in Patel is fixed at 16, Patel does not teach that the process must always start at ACR = 16. This anticipates, or at the least makes obvious, claim 1. Also, when ACR is 16, the value of R will be 17 as shown in the table below.
Patel is also recalculating the R value and Vac in subsequent blood draw cycles – see [0063] and [0064], teaching that target volume of plasma product is periodically recalculated throughout the plasmapheresis procedure. Thus claims 1, 2. 9-11 and 14 are anticipated, since the calculated ratio matches that of applicant’s in at least one example.
Applicant defines the value of R in page 4, lines 14-15, as “ratio of the anticoagulant composition to the donor's uncoagulated blood during the apheresis extraction process is 1 :R,” which definition is the same as in Patel, but then applicant redefined R using an equation that is different. A comparison of the definitions and the example cited therein is shown below:
Applicant’s equation:
Patel’s equation 7:
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Or, ACR = (Vc/Vac – 1)/(1-Hct) = R-1
R value calculated in page 4, line 25
18.86
ACR value for the same example:
17.86
R value is 17.0
For ACR = 16.0
The aim is to calculate Vac using the equation for R as recited in the claims. Solving the equation for Vac gives: Vac = Vc/(R(1-Hct)+Hct).
Compare this equation to Patel’s equation for Vac, above right. The denominator R(1-Hct)+Hct, when substituted for ACR = R-1 results in 1+ ACR.(1-Hct), as in Patel.
(Note: Hct in Patel’s equation is expressed as %, which is converted to decimal fraction for subsequent analysis.)
Applicant’s R value is Patel’s ACR +1, and the calculated volume of anticoagulant is the same as shown in the table
Claims 4, 8: while repeating the process steps to claim 1, recite the amount of AC in collected plasma as 9.1% or less. Patel’s process (Id.) would have the same result, if started with the FDA nomogram of 1:16 ratio, or with Patel’s equation. Vb/Vac = 16. Therefore, (Vb+Vac)/Vac would be > 16.
Claims 5-7: HCT value is determined initially externally and then internally as claimed. When external and internal values are the same, it is like a combination.
Claims 9-11: while Patel does not teach this explicitly, the ratio would be in that range.
Claim 13: blood plasma collected is not a patentable invention, but a routine process.
The teaching of Patel also optimizes such collection – see the abstract. The plasmapheresis is fixed volume – see [0056]. See also [0014] and [0016]-[0018].
While Patel may not be describing the steps of claim 1 and claim 4 verbatim, it teaches the process in great details, and such steps are implicit. Moreover, applicant also admits in page 2, that this is a known and routine process.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered. They are addressed in the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777