DETAILED ACTION
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.
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 § 101
Claims 1-3,5,10-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to
an abstract idea without significantly more.
Step 1: Is the Claim to a Process, Machine, Manufacture or Composition of Matter?
Claims 1-14 recite a series of steps for characterizing a solution S₀ comprising a plurality
of solutes. Thus, these claims are to a process, which is one of the statutory categories of invention.
Step 2A: Prong One: Does the Claim Recite an Abstract Idea?
Representative claim 1 recites:
A method for characterizing a solution So comprising a plurality of solutes, which
comprises at least the steps consisting in:
a) subjecting the solution So to a sequence of N rows i of partitions, i ranging from 1
to N and N being greater than or equal to 2, wherein the solution So comprises a synthetic substance comprising a radiolabel and at least one impurity, the rows i of partitions comprising: [the examiner
finds that the foregoing underlined elements recites a mathematical concept, (per MPEP2106.04(a)(2) A iv “organizing information and manipulating information through mathematical correlations”. Refer to equation 4-9b see specification]
for i=1, a mixture of a sample of the solution So with a volume of an organic Sorg solution of n-octanol or aqueous Saq solution or water immiscible with the solution So to obtain, after separation of the mixture into two phases, an aqueous phase Φ(i=1,aq) and an organic phase Φ(i=1,org); and
for i=2 to N,
a mixture of each aqueous phase Φ(i-1,aq) with a volume of the solution Sorg to obtain,
after separation of the mixture into two phases, an aqueous phase Φ(i,aq) and an organic
phase Φ(i,org);
a mixture of each organic phase Φ(i-1,org) with a volume of the solution Sₐq
to obtain, after separation of the mixture into two phases, an aqueous phase Φ(i,aq) and an
organic phase Φ(i,org);
b) subjecting all the aqueous and organic phases obtained at the row N to a
measurement of radioactivity of the radiolabel as an extensive and conservative quantity X, the radioactivity being measured by liquid scintillation, to obtain measured values of radioactivity, and measuring radioactivity in the solution So to obtain an initial value Xo; [the examiner finds that the foregoing underlined elements recite routine data gathering broadly and generically recited, see paragraph [0017], [0082], [0152]
c) defining theoretical values corresponding to partition coefficient values Dₖ, with y
greater than or equal to 2 and k ranging from 1 to y; [the examiner finds that the foregoing underlined elements recite a mathematical concept, namely constructing mathematical models/theoretical simulations, see paragraphs [0120]-[0142]]
d) carrying out a parametric adjustment to obtain a distribution of the solutes of the solution So as a function of to the y partition coefficient values Dₖ, wherein the parametric adjustment is constrained by conservation of radioactivity relative to the initial value Xo by
d(0) comparing the measured values to the theoretical values to the theoretical values according to lipophilicity values of the solutes expressed as a function of Dₖ,
wherein step d) provides (i) a fraction of radioactivity attributable to the synthetic substance, (ii) a fraction attributable to the impurity, and (iii a lipophilicity value for the impurity. [the examiner finds that the foregoing underlined elements recite a mathematical concept, namely mathematical comparison of data and models to derive information (solute distribution), see paragraphs [0143]-[0145]]
Step 2A: Prong Two: Does the Claim Recite Additional Elements That Integrate the
Abstract Idea into a Practical Application?
The elements that are not underlined above are the additional elements.
The examiner finds that each of the following additional elements merely recites the words
"applying" (or an equivalent) with the abstract idea, or merely includes instructions to implement
the abstract idea on a computer, or merely uses a computer as a tool to perform the abstract idea:
Thus, taken alone, the additional elements do not integrate the abstract idea into a practical
application. For example, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology.
Step 2B: Does the Claim Recite Additional Elements That Amount to Significantly More than the Abstract Idea?
The examiner finds that the additional elements do not amount to significantly more than
the abstract idea for the same reasons discussed above with respect to the conclusion that the
additional elements do not integrate the abstract idea into a practical application.
Claims 2-3,5,10-21 remain directed to the abstract idea, namely the mathematical concepts of
organizing, representing, and manipulating data. The additional elements recited in the claims,
such as specifying the number of partitions (claim 2), limiting the type of solution to aqueous or
organic and defining solvent classes (claims 3,5,14), applying mathematical equations to define theoretical vectors (claim 10), performing weighting and adjustment calculations (claims 11-12), or expressing distributions in histogram form (claim 13), merely add field-of -use limitations, data gathering, or post solution presentation of results.
These steps represent conventional chemical environments and routine laboratory activities that
do not integrate the abstract idea into a practical application. Accordingly, when considered as an
ordered combination, claims 1-3,5,10-21 do not amount to significantly more than the abstract idea itself.
As to REMARKS:
As to the last paragraph of p. 7; the manner of implementation does not appear to raise the claims to more than the abstract idea. Consider that the method is limited to characterizing a solution. The claims referred to do not provide a clear indication of improvement in technology.
As to the second paragraph of p. 8; the record does not reflect the method provides a “meaningful” output. It’s not apparent that there is an improvement in technology in this instance. The method does what is depicted, but is directed to an algorithm that takes data, manipulates data, and characterizes. The record presently lacks any description of improvement that provides for significantly more.
As to the third paragraph of p. 8; “transforms a physical sample” is part of the data gathering in the method. It’s not as if the claim is directed to a new composition of matter.
As to the last paragraph of p. 8, the phrase “that cannot be obtained from a single partition or conventional measurement”, thus will “thereby improving” the analytical capability” by itself is not improvement within another technology. Any improvement that provides significantly more than the abstract idea should be an improvement within the particular technology as a whole. Still, the record does not support an alleged improvement as compared to resolution relative to the single partition or conventional solution characterizations.
As to the second paragraph of page 9; there is an algorithm. The arguments relating to different materials do not change such designation. The record need reflect that the method of claim 1 somehow improves the technology, be it relating to accuracy or beneficial economics. To date, the arguments do not appear to support such.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT R RAEVIS whose telephone number is (571)272-2204. The examiner can normally be reached from Mon to Fri from 8am to 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kristina DeHerrera, can be reached at telephone number 303-297-4237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/ROBERT R RAEVIS/Primary Examiner, Art Unit 2855
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