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
DETAILED ACTION
Response to Amendment
This action is in response to applicant arguments filled on 01/22/2026
Claims 1-20 have been previously canceled.
Claims 21, 34, and 40 have been amended.
Claim 42 has been added new.
Claims 21-42 are presented for examination.
Detailed Action
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 21-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim(s) recite(s) subject matter within a statutory category as a process (claims 21-33 and 41), machine (claims 34-39), and manufacture (claims 40) which recite steps of: (claims 21, 34, and 40) calculating a demand profile, calculating a buffer quantity, calculating a supply plan, and outputting the supply plan.
Independent Claims
Step 2A, Prong One:
These steps of (claims 21, 34, and 40) calculating a demand profile, calculating a buffer quantity, calculating two or more confidence values, and calculating a supply plan, as drafted, under the broadest reasonable interpretation (BRI), include performance of the limitation in the mind and mathematical calculations but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the (claim 21) computer-implemented and processor and (claims 34 and 40) processor and storage medium language, these steps in the context of these claims encompass a mental process of the user and mathematical calculations.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and mathematical calculations but for the recitation of generic computer components, then it falls within the “Mental Processes” and “Mathematical Concepts” groupings of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of (claim 21) computer-implemented and processor and (claims 34 and 40) processor and storage medium language; and (claims 21, 34, and 40) controlling, with a randomization and trial supply management system, distribution of the clinical supply based on the supply plan, amount to invoking computers as a tool to perform the abstract idea, see applicant’s specification Figure 8 and [0080], see MPEP 2106.05(f)).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B:
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Dependent Claims
Step 2A, Prong One:
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 22-28, 33, and 35-42, reciting further calculations, forecasts, determinations, and comparisons, which a mental process and/or a mathematical calculation).
Step 2A, Prong Two:
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims, such as:
claims 29-31, reciting NLP at such a high level as to amount to general instructions to “apply it” to the claimed invention; claim 32, reciting an RTSM system and API implementation at such a high level as to amount to general instructions to “apply it” to the claimed invention; and claim 33, reciting transmitting a notification, which are additional limitations which amount to invoking computers as a tool to perform the abstract idea
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B:
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to mere instructions to apply an exception.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to Arguments
Applicant argues the 101 rejection. The Applicant argues that controlling…. Distribution of the clinical supply based on the supply plan”. Reflects improvement to the technical field of supply distribution for clinical trials. In addition, claim 21 recites a particular solution to the problem of controlling distribution of supplies in a clinical trial. Thus, claim 21 is patent eligible at least improves the technical filed of supply distribution for clinical trials.
The Examiner respectfully disagrees. Controlling the distribution of the clinical supply is an extra solution activity. “A transformation that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more (or integrate a judicial exception into a practical application). For example, in Mayo the Supreme Court found claims regarding calibrating the proper dosage of thiopurine drugs to be patent ineligible subject matter. The Federal Circuit had held that the step of administering the thiopurine drug demonstrated a transformation of the human body and blood. Mayo, 566 U.S. at 76, 101 USPQ2d at 1967. The Supreme Court disagreed, finding that this step was only a field-of-use limitation and did not provide significantly more than the judicial exception. Id. See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively. In addition, the claim does not recite any technical improvement. The claim does not recite any of the following: • An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Conclusion
THIS ACTION IS MADE FINAL. 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 MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/Primary Examiner, Art Unit 3687
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