DETAILED ACTION
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 .
Claims 1-20 are pending in this application and were examined on their merits, Claims 14-20 are acknowledged as withdrawn, Claims 1-13 were examined on their merits.
The rejection(s) of Claims 1-13 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, have been withdrawn due to the amendments to the claims filed 07/06/2026.
Drawings
Figure 5 should be designated by a legend such as --Prior Art-- because only
that which is old is illustrated. See US 2018/0154054 A1, Fig. 1. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application.
The replacement sheet(s) should be labeled "Replacement Sheet" in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures.
If the changes are not accepted by the Examiner, the Applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 12 are newly objected to because of the following informalities:
The word “target” should be inserted before “minimum” in the last line of the claims.
Claims 14-20 are newly objected to because of the following informalities: The claims are indicated as “withdrawn” but are not present in the claim set. Appropriate correction is required.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-13 are newly rejected under 35 U.S.C. § 101 because the claimed invention is directed to a Judicial Exception without significantly more, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
The claim(s) recite(s): “sorting the plurality of intermediate volumes into bins based on the known content of the fluid component” and "executing a combination selection algorithm to determine a plurality of combinations of at least two of the intermediate fluid volumes, wherein each intermediate fluid volume is assigned to only one of said plurality of combinations, each combination has a content of the fluid component at least equal to a target content of the fluid component for a fluid product,
and said at least two of the intermediate fluid volumes are assigned for each combination so as to maximize the number of combinations each having a target content of the fluid component at least equal to the minimum content of the fluid component for the fluid product", which are Abstract Ideas/mental steps. This judicial exception is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Step 1) The claims are directed to a process
Step 2, P1) The claim(s) recites the Judicial Exception set forth above. The identified claim limitations fall into the group of abstract ideas or mental processes, for the following reasons. In this case, the above cited recitations of Claim 1, can be practically performed in the mind by comparing the fluid content amount of each intermediate fluid volume to an unspecified “target" content of an unspecified fluid component.
Similarly, the “sorting” of a plurality of intermediate fluid volumes into categories/bins and "assigning" at least two intermediate fluid volumes with a known content of a fluid component for each combination can be practically performed in the mind by analyzing the fluid component content of each intermediate in the combination, as compared to the unspecified "minimum" content of the fluid component. While the claims now recite the use of a generic computer/controller to perform the process, the mental steps are performed on a generic computer which is used as a tool to perform the mental process. See the MPEP at 2106.04(a)(2), III, C. With regard to Claims 7, 8, 9, 10, 11, 12 and 13, the steps of: "determining", "calculating", "establishing" and "assigning", also fall into the group of abstract ideas or mental processes, as they amount to a mere organization of possible combinations of the provided intermediate fluid volumes.
Step 2, P2) The claims do not recite additional elements that integrate the exception into a practical application. Claim 1 recites "providing intermediate fluid volumes having a known content of a fluid component", this is mere data gathering of the preliminary components which are to be later manipulated to achieve the fluid product(s). Claim 1 further recites, "actuating a pump and one or more flow control elements of said pooling system to pool the plurality of intermediate fluid volumes according to the determined plurality of combinations, with each combination of pooled intermediate fluid volumes defining a fluid product having a content of the fluid component at least equal to the minimum content of the fluid component".
This amounts to mere instructions to "apply" the Judicial Exception and/or is a general linkage of the Judicial Exception to a particular field of use, e.g. combining fluids to obtain a fluid product with desired characteristics. Claim 2 merely provides a generic means by which the content of at least one of the intermediate fluid volumes is obtained, Claim 3 merely defines the fluid component and Claims 4-6 merely further define the composition of the intermediate fluid volumes.
Step 2B) The claims do not recite additional elements that amount to significantly more than the Judicial Exception. As discussed above, Claim 1 recites "providing intermediate fluid volumes having a known content of a fluid component", this is mere data gathering of the preliminary components which are to be later manipulated to achieve the fluid product(s). Claim 1 further recites, "actuating a pump and one or more flow control elements of said pooling system to pool the plurality of intermediate fluid volumes according to the determined plurality of combinations, with each combination of pooled intermediate fluid volumes defining a fluid product having a content of the fluid component at least equal to the minimum content of the fluid component". This amounts to mere instructions to "apply" the Judicial Exception and/or is a general linkage of the Judicial Exception to a particular field of use, e.g. combining fluids to obtain a fluid product with desired characteristics. Claim 2 merely provides the means by which the content of at least one of the plurality of intermediate fluid volumes is determined. The claim is recited at a high degree of generality being drawn to a generic optical technique and any generic content. Claim 3 merely defines a possible fluid component, Claim 4 provides a possible fluid volume component and Claims 4-6 merely define possible components of the intermediate fluid volumes.
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself.
Response to Arguments
Applicants’ arguments, see Remarks, filed 07/06/2026, with respect to the above withdrawn objection/rejection have been fully considered and are persuasive.
Applicant's remaining arguments have been fully considered but they are not persuasive.
The Applicant argues that Claim 1 has been amended to require a “computer-implemented” method using a “controller” of a fluid component system comprising a pump and one or more flow control elements. Applicant notes the controller “determines” combinations of measured intermediates and “actuates” the pump/flow control system(s) to pool intermediate volumes according to the determined combinations. Applicant concludes that the amended claims are not directed to Abstract ideas but to physical processes (Remarks, Pg. 8, Lines 19-22 and Pg. 9, Lines 1-7.
This is not found to be persuasive for the following reasons, as discussed above, while the claims may now recite the use of a generic computer/controller to perform the process, the mental steps are performed on a generic computer which is used as a tool to perform the mental process. See the MPEP at 2106.04(a)(2), III, C. Further, the “actuation” of the pump/flow controller(s) amounts to mere instructions to "apply" the Judicial Exception and/or is a general linkage of the Judicial Exception to a particular field of use, e.g. combining particular fluids to obtain a fluid product with desired characteristics.
The Applicant argues that the instant claims are not directed to an Abstract Idea/mental process, noting the requirement of a controller/fluid control system(s), “establishing” bins, “evaluating” combinations and “actuating” the pump/flow control systems to pool intermediates according to determined combinations. Applicant concludes these are not mental steps performed in the human mind but physical steps
(Remarks, Pg. 9, Lines 18-22 and Pg. 10, Lines 1-9).
This is not found to be persuasive for the following reasons, as discussed above, the presence of a generic “controller” which “actuates” a pump/flow control systems is no more than the application of the judicial exceptions/mental steps. The “establishing” or sorting into bins/categories and “evaluating” or determining combinations are all mental steps which can be performed either in the human mind or by using a generic computer system as a tool. The “actuating” step merely describes what the controller/flow control system(s) does when implementing the judicial exceptions.
The Applicant argues that Claim 1 recites specific rules/constraints for “determining” the combinations, and is not a result-oriented claim that states a desired outcome. Applicant asserts the claim recites specific selection steps used to control the physical pooling and are not mental steps (Remarks, Pg. 10, Lines 10-20).
This is not found to be persuasive for the following reasons, the presence of certain rules/constraints on a process involving mental steps/abstract ideas does not render the claim patent eligible. The claim is in fact, result oriented and states a desired outcome, e.g. the preparation of a fluid product having some content of fluid component. The steps to achieve this result are dependent upon the application of abstract ideas/mental steps.
The Applicant argues that the claims are integrated into a practical application because the controller “uses” measured values, “assigns” the fluid volumes to bins, “determines” combinations thereof to satisfy certain requirements and “actuates” a pump/flow controllers to pool intermediates according to the determinations. Applicant concludes that the result is not information, a display or mental conclusion but a plurality of fluid products within the required parameters (Remarks, Pg. 11, Lines 8-15).
This is not found to be persuasive for the following reasons: the claims do not recite additional elements that integrate the exception into a practical application.
Claim 1 recites "providing intermediate fluid volumes having a known content of a fluid component", which is mere data gathering of the preliminary components which are to be later manipulated to achieve the fluid product(s). Claim 1 further recites, "actuating a pump and one or more flow control elements of said pooling system to pool the plurality of intermediate fluid volumes according to the determined plurality of combinations, with each combination of pooled intermediate fluid volumes defining a fluid product having a content of the fluid component at least equal to the minimum content of the fluid component". This amounts to mere instructions to "apply" the Judicial Exception and/or is a general linkage of the Judicial Exception to a particular field of use, e.g. combining fluids to obtain a fluid product with desired characteristics. Claim 2 merely provides a generic means by which the content of at least one of the intermediate fluid volumes is obtained, Claim 3 merely further defines the fluid component and Claims 4-6 merely further define the composition of the intermediate fluid volumes.
Applicant argues that the claimed process effects a particular transformation as the controller implemented determination of combinations in a fluid pooling process transforms a plurality of intermediates into pooled fluid products with desired characteristics. Applicant concludes the claim is directed to application of computational steps in a physical process not the computational steps in isolation (Remarks, Pg. 11, Lines 16-22 and Pg. 12, Lines 1-2).
This is not found to be persuasive for the following reasons, there is no transformation of an article from a different state or thing. That is the intermediates are still the same fluids they were originally, just combined with other fluids. Further, the alleged “intermediates” and “fluid products” are not particular, being drawn to all possible fluids and not requiring any different function or use thereof. As discussed above, the limitations amount to mere instructions to "apply" the Judicial Exception and/or is a general linkage of the Judicial Exception to a particular field of use, e.g. combining fluids to obtain a fluid product with desired characteristics. Claim 2 merely provides the means by which the content of at least one of the plurality of intermediate fluid volumes is determined. The claim is recited at a high degree of generality being drawn to a generic optical technique and any generic content. Claim 3 merely defines a possible fluid component, Claim 4 provides a possible fluid volume component and Claims 4-6 merely define possible components of the intermediate fluid volumes. Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception.
The Applicant argues the claimed process improves an existing technical process in that typical platelet pooling may create inefficiencies that prevent preparation of a maximum number of products from a given number of whole blood units and is therefore a practical application of the judicial exception (Remarks, Pg. 12, Lines 3-13).
This is not found to be persuasive for the following reasons, the claims do not themselves reflect any improvement in the field of use of blood pooling technology, being drawn to generic fluids and components thereof. Thus, the claims amount to gathering data on generic fluids and components with a high level of generality, analyzing the data and applying that analysis to prepare undefined products.
The Applicant argues the claims recite an ordered combination of steps that are not routine, conventional and well-understood in the art and thus amount to significantly more than the judicial exception. Applicant asserts the steps are not generic instruction to “apply” an abstract idea, or mere data gathering followed by insignificant post-solution activity and the “determining” step is functionally integrated with the physical pooling step (Remarks, Pg. 12, Lines 16-21 and Pg. 13, Lines 1-19).
This is not found to be persuasive for the following reasons, the additional elements to the claims amount to "providing intermediate fluid volumes having a known content of a fluid component", which is mere data gathering of the preliminary components which are to be later manipulated to achieve the fluid product(s). This would also appear to be routine and conventional in the art, such as providing stock solutions which can be mixed with other components to provide different concentrations.
Claim 1 further recites, "actuating a pump and one or more flow control elements of said pooling system to pool the plurality of intermediate fluid volumes according to the determined plurality of combinations, with each combination of pooled intermediate fluid volumes defining a fluid product having a content of the fluid component at least equal to the minimum content of the fluid component". This amounts to mere instructions to "apply" the Judicial Exception and/or is a general linkage of the Judicial Exception to a particular field of use, e.g. combining fluids to obtain a fluid product with desired characteristics. Claim 2 merely provides the means by which the content of at least one of the plurality of intermediate fluid volumes is determined. The claim is recited at a high degree of generality being drawn to a generic optical technique and any generic content. Claim 3 merely defines a possible fluid component, Claim 4 provides a possible fluid volume component and Claims 4-6 merely define possible components of the intermediate fluid volumes. Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception.
The Applicant argues that the “pooling” is not mere application of the judicial exception or general linkage to a particular field of use. Applicant asserts the step is a physical step used to create fluid products wherein the “determining” step used to “select” which intermediates should be pooled and then “actuating” the pump/flow controller(s) to perform the pooling.
Applicant states the claims do not use a computer as a tool to perform the judicial exception, but use the “controller” to perform the physical operation which is a technological and practical improvement in the production of pooled fluid products (Remarks, Pg. 14, Lines 6-21).
This is not found to be persuasive for the following reasons, as discussed above, the claims are not drawn to either an improvement in the technology or practical application of the additional elements. As discussed above, while the claims may now recite the use of a generic computer/controller to perform the process, the mental steps are performed on a generic computer which is used as a tool to perform the mental process. See the MPEP at 2106.04(a)(2), III, C. The presence of a generic “controller” which “actuates” a pump/flow control systems is no more than the application of the judicial exceptions/mental steps. The “establishing” or sorting into bins/categories and “evaluating” or “determining” of combinations are all mental steps which can be performed either in the human mind or by using the generic computer system as a tool. The “actuating” step merely describes what the controller/flow control system(s) does when implementing the judicial exceptions.
The Applicant argues that Fig. 5 illustrates an embodiment of the invention which is disclosed as an example system configured for use with the claimed pooling system (Remarks, Pg. 15).
This is not found to be persuasive for the following reasons, Fig. 5 is exactly the same as Fig. 1 of US 2018/0154054 A1 and as such should be designated by a legend such as --Prior Art-- because only that which is old is illustrated.
Conclusion
No claims are allowed.
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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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