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.)
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 anticoagulant (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.]
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Patel’s third aspect is described in [0081]. In this aspect, after determining the patient’s whole blood volume, Hct and the volume of raw plasma to be collected (VRP) based on the whole blood volume, volume of anticoagulant required (VAC) is calculated by using the equation:
VAC=VRP*(ACR*(l-Hct)).
Blood is withdrawn after the above steps and AC is added to the collected blood.
Applicant’s equation in claim 1 is similar; VRP is Vc in applicant’s equation, and ACR = R-1, as sown below. The equations have two independent variables, Vc (or VRP) and R (or ACR.) In both cases one of these is arbitrarily selected. Since applicant’s claims 1 calculates, R, the Vac appears to be arbitrarily selected.
Patel calculates volume of AC using equations in [0049] before the plasmapheresis is started. The ratio used is ACR, defined as defined as Volume of drawn blood / volume of AC added, equation 3 of Patel at [0049].
Patel’s equation is 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 the “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 also recalculates the ACR 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 claim 1is anticipated, since the calculated ratio matches that of applicant’s in at least one example.
Relation between R and ACR:
From the disclosure at page 4, lines 24-27, applicant’s R is (Volume of drawn blood + volume of AC added) / volume of AC added.
Therefore, Patel’s ACR = R-1.
Applicant literally 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 that of ACR in Patel (Patel, equation 3 in [0049], but then applicant redefined R using an equation that is different.
A further 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: 18.857
ACR from Figs. 7 and 81 of Patel:
17.857
R value is 17.0
for ACR = 16.0
1: Patel’s fig. 8 shows 8 ml of additional raw plasma collected by their method, giving raw plasma as 800; collected plasma product as 880, and AC as 80, which are the same values as in applicant’s example. See figs. 7 and 8 at raw 3, donor weight of 175 & up; Hct at 44%.
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.
Dependent claims:
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.
"[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968)
Response to Arguments
Applicant’s arguments of 4/1/26 with respect to claim(s) have been considered. They are not persuasive.
Argument: “[i]n the method disclosed by Patel, the aim is the optimization of the plasma volume to be collected in each plasmapheresis cycle in view of the HCT value. See, for example, Abstract,” and “[i]n contrast, the claimed method of the present invention determines the volume of AC before the separation.” This argument does appear to be erroneous. The claimed invention does not recite determining the volume of AC, but recites “R is calculated according to the following equation…” In claim 4, step b), again, it is also the ratio R that is calculated. Also, the Vac term represents the volume of anticoagulant in the collected plasma, and not the volume of AC added to the blood.
Patel, on the contrary, calculates volume of AC using equations in [0049] before the plasmapheresis is started. In fact, while applicant’s claims do not recite determine the volume of AC, Patel does: See [0049] and [0081]. See also the paragraph in parenthesis in [0049] which states that “this yields a slightly different result from the FDA nomogram…”
About the pump 11 pumping 18.857 units for each unit of AC pump 2: if this is applied using Patel method, for every unit of pump 2, blood drawn = ACR = 17.857. This is mixed with AC at the phlebotomy needle, and pumped by pump 11, giving the same ratio at pump 11, of 18.857. (Patel’s example is the same in figures 7 and 8, 3rd raw, 44% Hct, as shown in the table in the rejection.
In conclusion, there is no difference in Patel’s teachings to the claimed invention, except for using ACR instead of R. Yes, Patel does not explicitly state about minimizing the excess anticoagulant. Nonetheless, the outcomes are the same, because the expressions for calculating the amount of AC or Vac are the same; only how the ratio is defined is different.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
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