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.
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-13) in the reply filed on 12/19/2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious search and/or examination burden to examine both groups. This is not found persuasive because, as discussed in the prior action, the two groups were shown to be distinct and have acquired a separate status in the art due to their divergent classification and subject matter, such that each invention would necessitate unique and not necessarily co-extensive search terms and/or search strategies. Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/19/2025.
Claims 1-13 were examined on their merits.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
Figure 5 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected 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.
The term “minimum” in Claim 1 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2-13 are rejected as being dependent upon rejected Claim 1.
Claim 2 recites the limitation "the content". There is insufficient antecedent basis for this limitation in the claim as the prior lines of the claim recite “known content of a fluid component” and “a content of the fluid component”. Thus, it is unclear if the “content” of Claim 2 applies to a particular content or all of the contents recited in the preceding lines.
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 1-13 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a Judicial Exception without significantly more. The claim(s) recite(s):
“determining 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 minimum 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 content of the fluid component at least equal to the minimum content of the fluid component for the fluid product”, which is an Abstract Idea/Method of Organizing Human Activity (e.g. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
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 recitations of Claim 1 of: “determining a plurality of combinations of at least two of the intermediate fluid volumes”, amounts to a mere organization of possible combinations of the provided intermediate fluid volumes. The step of “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 minimum 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 content of the fluid component at least equal to the minimum content of the fluid component for the fluid product”, can be practically
performed in the mind by comparing the fluid content amount of each intermediate fluid volume to an unspecified “minimum” content of an unspecified fluid component.
Similarly, “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. 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 recites, “ pooling 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.
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 recites, “ pooling 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.
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. Hoeltge et al. teaches the determination of the optimal number of platelet concentrates per pool which will achieve a target dose (3.0 x 1011 cells), wherein it was determined that a total of at least 5 platelet concentrates per pool is necessary to achieve the target dose (Pg. 928, Abstract). While the reference provides a plurality of intermediate fluid volumes having a known content of platelets (platelet concentrates (Pg. 930, Fig. 2), neither the reference nor the prior art at large teaches or suggests the claimed steps of “determining a plurality of combinations” or “pooling the plurality of intermediate fluid volumes according to the determined plurality of combinations” to arrive at the desired fluid product.
Vermeij (US 2017/0202882 A1), cited in the IDS, teaches a method of preparing platelet products comprising: selecting a subset of whole blood units from a plurality of donated whole blood units, wherein each unit of the subset is within a specified range for one or more parameters selected from the group consisting of: hematocrit, hemoglobin, donor gender, whole blood volume, packed cell volume and platelet count, centrifuging the selected subset of units and isolating the platelet rich plasma therefrom (Pg. 27, Claim 1). Thus, while the reference provides a plurality of intermediate fluid volumes (selected subset of units) having a known parameter content, neither the reference nor the prior art at large teaches or suggests the claimed steps of “determining a plurality of combinations” of the unit subsets or “pooling the plurality of intermediate fluid volumes according to the determined plurality of combinations” to arrive at the desired fluid product.
No claims are allowed.
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.
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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 01/21/2026