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 1-28 has been considered and are addressed below. Claims 29-34 has been restricted
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 1-28 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 1-28 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, recite “creating a data representation comprising plurality of material state specifications for a pharmaceutical product using data gathered from at least one sensor acting on the pharmaceutical product, material state specifications including a maximum allowable material state change”, “correlating a minimum viable potency of the pharmaceutical product to the maximum allowable material state change”, “communicating the data representation of at least one participant of a supply chain of the pharmaceutical product sample”, “generating a specimen representation of a material state of a sample of the pharmaceutical product using data gathered on the pharmaceutical product sample”, “evaluating the specimen representation of the material state”, “determining whether the specimen representation of the material state of the sample exhibits a material state change greater than the maximum allowable material state change of the material state specifications.”
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “mental process” grouping of abstract ideas. 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, “one sensor” 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 does not recite additional element 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 does not recite additional element 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.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammond (2018/0372631) in view of Van Duren (2004/0191301).
With respect to claim 1 Hammond teaches a
method for evaluating potency-correlated material states of a state dependent pharmaceutical product, comprising:
creating a data representation comprising a plurality of material state specifications for a pharmaceutical product using data gathered from at least one sensor acting on the pharmaceutical product, the material state specifications including a maximum allowable material state change (Hammond paragraph 21 “detecting scattered light in the integrating sphere light collector; and analysing the detected light, wherein changes in the captured light as a function of time are indicative of a change in the biological material. The change in the biological material may be a change in cell state”);
correlating a minimum viable potency of the pharmaceutical product to the maximum allowable material state change (Hammond paragraph 42 “maximise the volume of the sample that can interact with reflected and diffused light circulating within the sphere”);
communicating the data representation to at least one participant of a supply chain of the pharmaceutical product (Hammond paragraph 51 “so that only scattered or reflected light is transmitted to the photodiode”);
generating a specimen representation of a material state of a sample of the pharmaceutical product using data gathered from at least one sensor acting on the pharmaceutical product sample (Hammond paragraph 82 “This allows starting bacterial concentration to be estimated using the values generated from the gompertz function”);
evaluating the specimen representation of the material state of the sample (Hammond paragraph 18 “Analysing the captured light may involve establishing the level of drug that kills or inhibits growth of a given organism.”).
Hammond does not teach determining whether the specimen representation of the material state of the sample exhibits a material state change greater than the maximum allowable material state change of the material state specifications.
Van Duren teaches to defeat abuse of a transdermal patch in response to elevation of the temperature of the patch beyond a threshold that approaches the temperature of water heated to, or near, boiling (Van Duren paragraph 10).
One of ordinary skill in the art would have found it obvious to combine the teachings of Hammond with Van Duren at the time of invention with the motivation of preventing the phase change material particles 16 or the material 18 from being released or transported through the top or side surfaces when the patch is unheated and also when heat is applied (Van Duren paragraph 19).
With respect to claim 2 Hammond in view of Van Duren teaches the method of claim 1, further comprising: discarding at least one pharmaceutical product if the specimen representation of the material state of the sample exhibits a material state change greater than the maximum allowable material state change of the material state specifications, wherein the at least one pharmaceutical product is associated with a corresponding localized supply of the sample of the pharmaceutical product (Hammond paragraph 47).
With respect to claim 3 Hammond in view of Van Duren teaches the method of claim 2, further comprising: communicating identification data of the at least one pharmaceutical product to be discarded to at least one participant of the supply chain of the pharmaceutical product (Hammond paragraph 47).
With respect to claim 4 Hammond in view of Van Duren teaches the method of claim 1, further comprising: accepting at least one pharmaceutical product for use if the specimen representation of the material state of the sample exhibits a material state change less than the maximum allowable material state change of the material state specifications, wherein the at least one pharmaceutical product for use is associated with a corresponding localized supply of the sample of the pharmaceutical product (Van Duren 19).
With respect to claim 5 Hammond in view of Van Duren teaches the method of claim 4, further comprising: communicating identification data of the at least one pharmaceutical product to at least one participant of the supply chain of the pharmaceutical product (Hammond paragraph 21).
With respect to claim 6 Hammond in view of Van Duren teaches the method of claim 1, further comprising: determining an estimated potency of the sample of the pharmaceutical product; and communicating the estimated potency of the sample to at least one participant of the supply chain of the pharmaceutical product (Hammond paragraph 62).
With respect to claim 7 Hammond in view of Van Duren teaches the method of claim 1, wherein the evaluating the specimen representation of the material state of the sample step further comprises: inputting at least one data component of the specimen representation of the material state of the sample of the pharmaceutical product into a neural network, wherein the neural network comprises a trained machine learning model (Hammond paragraph 5).
With respect to claim 8 Hammond in view of Van Duren teaches the method of claim 7, further comprising: categorizing, by the trained machine learning model, whether the specimen representation of the material state of the sample comprises an acceptable material state change or an unacceptable material state change (Hammond paragraph 5).
With respect to claim 9 Hammond in view of Van Duren teaches the method of claim 7, further comprising: training the machine learning model based on the data representation of the plurality of material state specifications for the pharmaceutical product (Hammond paragraph 5).
With respect to claim 10 Hammond in view of Van Duren teaches the method of claim 1, further comprising: communicating, at a local level, at least one communication indicative of whether (1) the specimen representation of the material state of the sample exhibits a material state change determined to be greater than the maximum allowable material state change of the material state specifications or (2) the specimen representation of the material state of the sample exhibits a material state change determined to be less than the maximum allowable material state change of the material state specifications, wherein the communication is chosen from the group comprising: a visual communication, an auditory communication, and/or a haptic communication (Hammond paragraph 51).
With respect to claim 11 Hammond in view of Van Duren teaches the method of claim 1, further comprising: communicating, across at least one blockchain network, at least one communication indicative of whether (1) the specimen representation of the material state of the sample exhibits a material state change determined to be greater than the maximum allowable material state change of the material state specifications or (2) the specimen representation of the material state of the sample exhibits a material state change determined to be less than the maximum allowable material state change of the material state specifications, wherein the communication comprises data corresponding to an evaluation outcome of the evaluating the specimen representation of the material state of the sample step (Hammond paragraph 53).
With respect to claim 12 Hammond in view of Van Duren teaches the method of claim 11, wherein the at least one blockchain network is accessible by a plurality of different participants of the supply chain of the pharmaceutical product (Hammond paragraph 52).
With respect to claim 13 Hammond in view of Van Duren teaches the method of claim 11, wherein the at least one blockchain network provides a permanent ledger for performing an audit (Hammond paragraph 18).
With respect to claim 14 Hammond in view of Van Duren teaches the method of claim 11, wherein the at least one blockchain network is only accessible by a subset of permissioned participants of the supply chain of the pharmaceutical product (Hammond paragraph 56).
With respect to claim 15. The method of claim 1, wherein the evaluating the specimen representation of the material state of the sample step further comprises evaluating the extent of chemical or conformational change in the pharmaceutical product (Hammond paragraph 75).
With respect to claim 16 Hammond in view of Van Duren teaches the method of claim 1, wherein the evaluating the specimen representation of the material state of the sample step further comprises evaluating the extent of phase separation in the pharmaceutical product (Hammond paragraph 45).
With respect to claim 17 Hammond in view of Van Duren teaches the method of claim 16, wherein the phase separation is chosen from the group comprising: agglomeration, flocculation, coalescence, creaming, and/or Ostwald ripening (Hammond paragraph 45).
With respect to claim 18 Hammond in view of Van Duren teaches the method of claim 1, wherein the pharmaceutical product is a vaccine developed for human and/or animal use (Hammond paragraph 72).
With respect to claim 19 Hammond in view of Van Duren teaches the method of claim 18, wherein the evaluating the specimen representation of the material state of the sample step further comprises evaluating the extent of change in the conformation of antigens (Hammond paragraph 74).
With respect to claim 20 Hammond in view of Van Duren teaches the method of claim 1, wherein the pharmaceutical product is a vaccine comprising an adjuvant (Hammond paragraph 75).
With respect to claim 21 Hammond in view of Van Duren teaches the method of claim 20, wherein the evaluating the specimen representation of the material state of the sample step further comprises evaluating the extent of phase separation of the coordinated antigen-to-adjuvant vaccine components (Hammond paragraph 74).
With respect to claim 22 Hammond in view of Van Duren teaches the method of claim 20, wherein the evaluating the specimen representation of the material state of the sample step further comprises evaluating the extent of phase separation of the non-coordinated adjuvant vaccine components (Hammond paragraph 68).
With respect to claim 23 Hammond in view of Van Duren teaches the method of claim 20, wherein the adjuvant comprises an oil and water emulsion (Hammond paragraph 56).
With respect to claim 24 Hammond in view of Van Duren teaches the method of claim 1, wherein the pharmaceutical product is a vaccine component material (Hammond paragraph 5).
With respect to claim 25 The Hammond in view of Van Duren teaches the method of claim 1, wherein the pharmaceutical product is a vaccine component comprising an adjuvant (Hammond paragraph 75).
With respect to claim 26 Hammond in view of Van Duren teaches the method of claim 1, wherein the creating the data representation comprising the plurality of material state specifications for a pharmaceutical product further comprises: utilizing a phase contrast microscopy process to evaluate a size of the agglomerates (Hammond paragraph 56).
With respect to claim 27 Hammond in view of Van Duren teaches the method of claim 1, wherein the evaluating the specimen representation of the material state of the sample further comprises evaluating a size of the agglomerates (Hammond paragraph 67).
With respect to claim 28 Hammond in view of Van Duren teaches the method of claim 1, wherein the at least one sensor comprises a 2-D optical detector (Hammond paragraph 68).
Conclusion
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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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684