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 .
DETAILED ACTION
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 23 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 23 recites “A computer-implemented method for screening polymers for medication receptacles comprising: receiving data identifying a medication comprising a concentration of a drug product in a background fluid and a polymeric composition of a surface of a receptacle for housing the medication; predicting, by a drug substance adsorption behavior model using the received data, a percent of dose lost and an interaction behavior between the medication and the receptacle, the drug substance absorption behavior model being generated using one or more empirical tests using quartz crystal microbalance sensors; and providing data characterizing the predicted percent of dose lost and the interaction behavior.”
Claim 26, in view of the claim limitations, recites the abstract idea of “receiving data identifying a medication comprising a concentration of a drug product in a background fluid and a polymeric composition of a surface of a receptacle for housing the medication; predicting, by a drug substance adsorption behavior model using the received data, a percent of dose lost and an interaction behavior between the medication and the receptacle, the drug substance absorption behavior model being generated using one or more empirical tests using quartz crystal microbalance sensors; and providing data characterizing the predicted percent of dose lost and the interaction behavior.”
As a whole, in view of the claim limitations, but for the computer components and systems performing the claimed functions, the broadest reasonable interpretation of the recited “receiving data identifying a medication comprising a concentration of a drug product in a background fluid and a polymeric composition of a surface of a receptacle for housing the medication; predicting, by a drug substance adsorption behavior model using the received data, a percent of dose lost and an interaction behavior between the medication and the receptacle, the drug substance absorption behavior model being generated using one or more empirical tests using quartz crystal microbalance sensors; and providing data characterizing the predicted percent of dose lost and the interaction behavior.”; therefore, the claim recites mental processes. Accordingly, the claim recites a mental process, and thus, the claim recites an abstract idea under the first prong of Step 2A.
This judicial exception is not integrated into a practical application under the second prong of Step 2A. In particular, the claims recite the additional elements beyond the recited abstract idea of“[a] computer- implemented method” and “the method is carried out by one or more physical processors configured by machine-readable instructions” as recited in claim 26, individually and when viewed as an ordered combination, and pursuant to the broadest reasonable interpretation, each of the additional elements are computing elements recited at high level of generality implementing the abstract idea on a computer (i.e. apply it), and thus, are no more than applying the abstract idea with generic computer components.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception under Step 2B. As noted above, the aforementioned additional elements beyond the recited abstract idea, as an order combination, are no more than mere instructions to implement the idea using generic computer components (i.e. apply it), and further, generally link the abstract idea to a field of use, which is not sufficient to amount to significantly more than an abstract idea; therefore, the additional elements are not sufficient to amount to significantly more than an abstract idea. Additionally, these recitations as an ordered combination, simply append the abstract idea to recitations of generic computer structure performing generic computer functions that are well-understood, routine, and conventional in the field as evinced by Applicant’s Specification at [0327] (describing that the disclosure is not limited to the disclosed implementations, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims). Furthermore, as an ordered combination, these elements amount to generic computer components performing repetitive calculations, receiving or transmitting data over a network, which, as held by the courts, are well-understood, routine, and conventional. See MPEP 2106.05(d); July 2015 Update, p. 7. Looking at these limitations as an ordered combination adds nothing additional that is sufficient to amount to significantly more than the recited abstract idea because they simply provide instructions to use a generic arrangement of generic computer components and recitations of generic computer structure that perform well-understood, routine, and conventional computer functions that are used to “apply” the recited abstract idea. Thus, the elements of the claims, considered both individually and as an ordered combination, are not sufficient to ensure that the claim as a whole amounts to significantly more than the abstract idea itself. Since there are no limitations in these claims that transform the exception into a patent eligible application such that these claims amount to significantly more than the exception itself, claims 23 and 26 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Allowable Subject Matter
Claims 1-22, 24, 25, 27 and 28 are allowed over prior arts.
The following is an examiner’s statement of reasons for allowance:
The primary reason for the allowance of claims 1-22, 24 and 25 is the inclusion of a computer-implemented method that includes the steps of: predicting, by a drug substance adsorption behavior model using the received data, a percent of dose lost and an interaction behavior between the medication and the receptacle; and providing data characterizing the predicted percent of dose lost and the interaction behavior; wherein the drug substance adsorption behavior model is generated by: measuring, during each test measurement, acoustic resonances of at least one quartz crystal microbalance (QCM) sensor having a coating corresponding to the surface composition of the respective receptacle, wherein different frequencies of measured harmonics forming part of the acoustic resonances correlate to adsorbed drug product by the surface composition; determining, for each test measurement based on the measured acoustic resonances, a percent of dose lost and an interaction behavior between the medication and the receptacle; and constructing the drug substance adsorption behavior model based on the determined percent of dose lost and the interaction behavior between the respective medications and the corresponding receptacles. It is these steps found in the claims, as they are claimed in the combination of, that has not been found, taught or suggested by the prior art of record which makes these claims allowable over the prior art.
The primary reason for the allowance of claims 27 and 28 is the inclusion of a computer-implemented method that includes the steps of: measuring, during each test measurement, acoustic resonances of at least one quartz crystal microbalance (QCM) sensor having a coating corresponding to a surface composition of the respective receptacle, wherein different frequencies of measured harmonics forming part of the acoustic resonances correlate to adsorbed drug product by the surface composition; determining, for each test measurement based on the measured acoustic resonances, a percent of dose lost and an interaction behavior between the medication and the receptacle; and constructing a drug substance adsorption behavior model based on the determined percent of dose lost and the interaction behavior between the respective medications and the corresponding receptacles. It is these steps found in the claims, as they are claimed in the combination of, that has not been found, taught or suggested by the prior art of record which makes these claims allowable over the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aastrup et al (US 9,533,881) disclose a method of covalently immobilizing a charged chemical species on or near a sensor surface of a mass-sensitive chemical sensor, the sensor surface bearing functional groups capable of forming covalent bonds with the chemical species, the method involving the application of an electric field between the charged chemical species and the sensor surface such that the electrostatic attraction therebetween is increased. Zhang et al (US 8,173,436) disclose a device that includes a piezoelectric resonator having a functionalized surface configured to react with target molecules, thereby changing the mass and/or charge of the resonator which consequently changes the frequency response of the resonator. The resonator's frequency response after exposure to a sample is compared to a reference, such as the frequency response before exposure to the sample, a stored baseline frequency response or a control resonator's frequency response. Orwar et al (US 2009/0274579) disclose methods relying on self-assembly, self-association, or drug screening, biomacromolecule separation and biosensing including SPR and QCM. Thus, the geometry of the device can be designed and customized for promoting specific functionalities that can be exploited for e.g., separation, reaction, and mixing phenomena in a thin film. Kaylor et al (US 2004/0078219) disclose a healthcare network including a biosensor associated with the user that generates a biosensor signal containing the information; and a personal data control means including receiving means for receiving the biosensor signal, input means for receiving a privacy input from the user, and output means for generating a response signal based on the biosensor signal and privacy input. The network also includes a data allocation and processing module including means for receiving the response signal, and means for generating and directing an output signal to the at least one outside source, wherein the module is responsive to the response signal, and wherein the availability of the information to the at least one outside source is responsive to the privacy input.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AN H DO whose telephone number is (571)272-2143. The examiner can normally be reached on M-F 7:5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricardo Magallanes can be reached on 571-272-5960. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AN H DO/Primary Examiner, Art Unit 2853