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 .
Status of Claims
Claims 1-29, 31 has been considered and are addressed below. Claims 30 has been cancelled.
Response to Arguments/Amendments
Applicant’s amendment filed on 7-10-26 has been entered and are addressed below.
Applicant argues that the claim impose meaningful limits on the claims and integrating any abstract idea into a practical application specifically, to reliably determine a state dependent pharmaceutical product has undergone potency reducing material state changes. Examiner respectfully disagrees. The collection of samples are part of data gathering/extra solution activity. The processing of the data obtained and the analysis are part of the abstract idea which can be mental process and can also be certain methods of organizing human activity then presenting and output based on the analysis, this is similar to that of Electric Power Group v Alstom.
Applicant argues that the present claims link the judicial exception to the technical environment of applying an optical sensor to a state dependent pharmaceutical sample. Examiner respectfully disagrees. The optical sensor is used to gather data, it does not improve the actual technology.
Applicant argues that the claim is similar to that of example 29 and 28. Examiner respectfully disagrees. The claims in example 29 and 28 are actually administering the adjusted dose. The instant claim generates a determination that is either displayed visually or audio or haptic or an electronic communication which broadly interpreted could be a report being presented or emailed.
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 1-29, 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-29, 31 are drawn to a computer implemented computer readable non-transitory medium, computer implemented method, system which is/are statutory categories of invention (Step 1: YES).
Independent claim 1, 29, 31, recite “processing the data obtained from the plurality of reference samples to correlate measurable properties of the characterized material states with known potencies of the reference samples, thereby generating a potency-correlated material state dataset; wherein the correlation comprises characterizing changes in measurable properties that correspond to changes in potency-correlated material states of the reference samples relative to a specified potency; training a machine learning model using the potency-correlated material state dataset, wherein the trained machine learning model learns non-linear associations between the measurable properties and the potency-correlated material states; providing access to the deployed trained machine learning model, wherein the machine learning model was deployed from a training environment to an operational state configured to evaluate samples of the state-dependent pharmaceutical product having an unknown condition; generating a specimen representation of material states of a sample of the state- dependent pharmaceutical product having an unknown condition using data gathered from at least one optical sensor acting on the sample, wherein the specimen representation is generated using the same measurable properties as the potency-correlated material state dataset; inputting the specimen representation into the deployed trained machine learning model to generate a model output comprising a quantitative characterization of one or more potency-correlated material states of the sample; and generating an output based on the model output, wherein the output comprises at least one of a visual communication, an auditory communication, a haptic communication, and/or an electronic communication.”
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “certain methods of organizing human activities” grouping of abstract ideas. Additionally this can also fall under mental process. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including, “using at least one optical sensor acting on the reference samples” which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the “processor” language is incidental to what it is “configured” to perform). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The claims recite additional element of ” obtaining data from a plurality of reference samples of the state-dependent pharmaceutical product having known potencies and corresponding characterized material states” which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 56 recite “a component such as a sensor, a processor, or a memory described as being configured to perform a task may be implemented as a general component that is temporarily configured to perform the task at a given time or a specific component that is manufactured to perform the task”.
Paragraph 32 recites “one sensor includes a 2-D optical detector.”
The claims recite additional element of “obtaining data from a plurality of reference samples of the state-dependent pharmaceutical product having known potencies and corresponding characterized material states” which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-28 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein. Additionally, the devices mentioned in dependents claim are used as input devices.
Conclusion
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 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 REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid R. Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684
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