DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Pro se filing
The Office recognizes that level of experience with U.S. patent practice may affect protection of inventions disclosed in an application. Nonetheless, an applicant may prosecute an application without the services of a registered patent attorney or agent (i.e. pro se filing including guidance on locating an attorney or agent -- MPEP 401 and the USPTO "Pro Se Assistance Program" at www.uspto.gov/patents-getting-started/using-legal-services/pro-se-assistance-program). As time allows, the examiner and the Office may provide or reference guidance in addition to that normally provided during examination.
Also, an interview may be requested for clarification and discussion of the issues in this action. The examiner's contact information appears at the end of this communication.
Status of claims
Canceled:
none
Pending:
1-25
Withdrawn:
4-7 and 9
Examined:
1-3, 8 and 10-25
Independent:
1
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
XXDATE
date format
Priority
As detailed on the 9/29/2022 filing receipt, this application was filed 10/1/2021, and there is no claim to earlier priority.
Election/Restrictions
Applicant’s election of claim 8 as species election in the reply filed on 06/15/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). As listed above, claims are withdrawn as drawn to nonelected inventions pursuant to 37 CFR 1.142(b), and the remaining claims have been examined as listed above. The restriction requirement is made final.
Claim Interpretation
The recited claims 1-3, 8 and 10-25 are missing properly defined steps required to recite the scope of the claimed invention. Therefore, claims 1-3, 8 and 10-25 are being interpreted as follows:
Claim 1: A method for blood transfusion information analysis comprising:
a classification scheme to be used to arrange patients into groups indicating the required antigen selection level by phenotype for optimal donor match, explaining which demographic, medical, and laboratory information should be considered, and assessing the sufficiency of a patient's available blood typing information;
determining and measuring of patient donor compatibility, measurement and comparison of unit selection decisions;
wherein the classification scheme is used to arrange donors by phenotype enabling optimization of unit selection for cryopreservation, and for maintaining an equilibrium between a high probability of finding requested red blood cell phenotypes and the excessive accumulation of red blood cell units that go unclaimed and ultimately expire.
Note: the recited “for the purpose of recommending specific blood product units/donors for transfusion candidates including those of complex cases, rare blood types and emergent situations to achieve: a better patient - donor match, prevention of alloimmunization and more effective prevention of transfusion hemolytic reactions, as well as improved optimization of the long-term storage of red blood cell units” is being interpreted as intended use for the claimed invention and not required steps.
Claim 2: The method of claim 1, further comprising:
classifying patients into groupings to optimize donor selection, combining demographics and medical conditions consisting of: a) clinical criteria: blood diseases, long-term transfusion therapies, and drugs that cause nonspecific red blood cell agglutination, b) laboratory conditions: the presence of specific and multispecific antibodies, and c) demographics: woman's age in the absence of relevant clinical and laboratory conditions.
Claim 3: The method of claim 2, further comprising:
classifying a patient into one of seven (7) transfusion risk groups where each group has its own required blood typing criteria; wherein the group is selected from: a) four transfusion risk groups are defined according to the required antigen matching rules, b) two groups consider unexpected specific antibodies in the matching process.
Claim 8: The method of claim 3, further comprising:
classifying a patient who has unexpected specific antibodies and a clinical blood system disease(s) into transfusion risk group five; wherein donor selection is required to be based on extended phenotype matching for thirteen transfusion dangerous antigens: ABO, D, K, C, c, E, e, Fya, Fyb, Jka, Jkb, S, s and antigens which correspond to one or more specific antibodies the patient possesses including: anti-D, -C, -c, -E, -e, -K, -k, - Fya, -Fyb, -Jka, -Jkb, -S, -s, - M, -N, -Lua, -Lub, -Lea,-Leb, -Kpa, -Kpb,-Jsa,-Jsb, and -Cw.
Claim 10: The method of claim 3, further comprising:
classifying a patient who requires an immediate transfusion and phenotype information is unavailable into transfusion
risk group zero; donor selection should be of phenotype: O, D-C-c+E-e+, and K- (0, ccdee, K-).
Claim 11: The method of claim 3, further comprising:
determining if patient's blood typing information is sufficient to perform donor matching; wherein determining consists of evaluating patient's available phenotype information against the patient's transfusion risk group antigen requirements.
Claim 12: The method of claim 1, further comprising:
evaluating the decision of a manually completed blood unit selection against the invention recommendation and to measure its quality by comparing the patient unit match scores and difference in priority factors.
Claim 13: The method of claim 12, further comprising:
measuring patient unit compatibility and rank patient compatible units; wherein patient compatible units are ordered by the value of the patient unit priority factor; wherein the patient unit priority factor is calculated by adding unit additional factors to patient donor priority factor; the highest-ranking available unit is recommended for the patient.
Claim 14: The method of claim 13, further comprising:
measuring patient donor compatibility based on the required demographic, phenotype, and antibody information as specified by the patient's transfusion risk group.
Claim 15: The method of claim 1, further comprising:
measuring patient donor match based on all available demographic, phenotype, antibody information.
Claim 16: The method of claim 14, further comprising:
additional patient donor matching logic for immunohematological conditions such as chimerism, and the presence of relevant alloantibodies and autoantibodies
Claim 17: The method of claim 17, further comprising:
providing the capability to quantitatively define the match results of patient based on donor compatibility, calculating patient unit selection score, and measuring, and compare unit selection decisions.
Claim 18: The method of claim 18, further comprising:
expressing the match score code which represents the degree of matching based on: a) exact match which represents identical patient and donor phenotypes, b) sufficient match which represents compatible patient and donor phenotypes, c) mismatch which represents incompatible patient and donor phenotypes.
Claim 19: The method of claim 18, further comprising:
clarifying by the priority factor which is a numerical measurement based on: a) an executed fine grain match rule result, b) a patient donor compatibility, c) a patient donor match d) a patient unit selection score, e) blood unit specific factors, and f) patient demographic relevant characteristics.
Claim 20: The method of claim 13, further comprising:
supplementing by the choice factor which defines the deviation from an exact match, as well as by choice depth which defines the number of antigen rules applied in matching.
Claim 21: The method of claim 14, further comprising:
measuring unit specific factors based on the storage method, expiration date, and phenotype usage type.
Claim 22: The method of claim 14, wherein:
donor phenotypes are classified into five (5) phenotype usage type categories, each which describes how red blood cell units of that category should be stored and managed for optimal blood bank operations for the purpose of maintaining a blood bank long-term storage equilibrium between a high probability of finding red blood cells with the requested phenotype and the excessive accumulation of red blood cells that go unclaimed and ultimately expire.
Claim 23: The method of claim 14, wherein:
donor phenotypes in a unique category are most compatible with recipient phenotypes of the 16 clinically relevant antigens of ABO, Rh, Kell, Kidd, Duffy and MNS blood group systems; these unique phenotypes contain only one antigen in the pairs: C/c, E/e, Fya/Fyb, Jka/Jkb, S/s, M/N; additionally, these phenotypes must not possess antigens A and B of the ABO system and K of the Kell system; also a subset of these unique phenotypes have the Fya or Fyb antigens of the Duffy system absent.
Claim 24: The method of claim 14, wherein:
donor phenotypes in an extraordinary category are rarely used because they are not compatible with most recipient phenotypes, however, they may be required for patients who are alloimmunized to most common antigens.
Claim 25: The method of claim 14, further comprising:
determining the recommended storage method of red blood cell units using phenotype classification; long term storage for every unit of unique phenotype and one (1) unit of extraordinary phenotype.
Drawings
In the instant drawings, Fig. 1, Figs. 3A-3D, and Figs. 4-6 are executed in color. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Objection to the Specification
The specification is objected to because pg. 45 contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 3, 8, 10, 16, 18, 22 and 25 are objected to because of the following informalities: all instant claims are missing proper indentation of presented elements/steps within each claim. MPEP 608.01(i) states “(i) where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation”. The examiner recommends MPEP 2111.02 for the use of proper preamble and MPEP 2111.03 for the use of proper transition phrases.
Claim 1 is objected to because of the following informality: the recited limitation is missing a linking term (the term “and” or the term “or” or the term “and/or”) before the term “a classification scheme to be used to arrange donors by phenotype”.
Claim 3 is objected to because of the following informality: the recited limitation is missing a linking term (the term “and” or the term “or” or the term “and/or”) before the term “(b)”.
Claim 8 is objected to because of the following informality: the recited limitation is missing a linking term (the term “and” or the term “or” or the term “and/or”) before the term “-Cw”.
Claim 10 is objected to because of the following informality: the recited limitation is missing a linking term (the term “and” or the term “or” or the term “and/or”) before both terms reciting “K-”:
Claim 16 is objected to because of the comma separating elements in a list of only two elements, e.g. "X and Y" not "X, and Y."
Claim 18 is objected to because of the following informality: the recited limitation is missing a conjunction (e.g. the term “and” or the term “or” or the term “and/or”) before the term “(c).”
In claim 22 "each which" is grammatically incorrect.
Claims 22 and 25 are inconsistent in their spelling of "long-term" vs. "long term," probably the former is correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Overall legal statement pertaining to all rejections under 112(b)
Claims 1-3, 8 and 10-25 are rejected under 35 U.S.C. 112(b) as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. Relatedly, for compact prosecution and examination, it may help to also amend the withdrawn claims so that the same amendments do not need to be tracked and applied later. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
Particular rejections under 112(b)
Each of claims 1-3, 8 and 10-25 is rejected as failing to recite the invention in the manner required by 35 U.S.C. 112(b). For example, the claims appear to be written in a narrative form and are replete with indefinite language. The structure and steps making up the claimed inventions must be clearly and positively recited. The structure must be organized so as to present a complete set of steps. Each claim must be one sentence and not multiple sentences as in claim 11. The claims as currently recited lack proper format. It is unclear what steps constitute the recited method claims. Thus, the scope of each claim is unclear. MPEP 608.01(i) and MPEP 608.01(m) provide guidance about drafting claims.
Also, each of claims 2-3, 8, 10-16 and 21-25 recites "The method of claim... to..." in which the recited "to..." causes the subsequent recitation to be interpreted as intended use, not clearly limiting the claim. As a general matter of patent claim interpretation, the grammatical construction of "to" followed by a verb may be interpreted as intended use not clearly limiting its claim. The relationship is unclear between the entire recitation of "to..." and the rest of the claim including the parent claim(s). It is unclear how or that the dependent claim modifies the parent claim(s). This rejection might be overcome by amending from, for example claim 2, "The method of claim 1 to classify patients into..." to "The method of claim 2, further comprising classifying patients into..."
Also, the relationships are unclear between each of claims 17-20 versus their respective parent claims 14, 17, 18 and 18. Each claim begins with a recited verb which does not make clear how the claim modifies its parent claim, at least because in each claim the subject of the first verb is unclear.
Claim 1 is indefinite as reciting multiple instances of relative language, as bolded in the following: “...including those of complex cases, rare blood types and emergent situations to achieve: a better patient-donor match … as well as improved optimization of the long-term storage... assessing the sufficiency of a patient's available blood typing information … an equilibrium between a high probability of finding requested red blood cell phenotypes and the excessive accumulation of red blood cell...” Each bolded instance renders the claim indefinite as a term of relative or vague degree or form of association, neither defined in the specification nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.) The following claims are rejected similarly due to their recited:
"unexpected" (claims 2, 3, 8),
"relevant" (claim 2, two instances, claim 16, claim 19 and claim 23),
"high" (claim 5),
"fine grain" (claim 19),
"patient demographic relevant" (claim 19),
"high" (claim 22),
"excessive" (claim 22),
"extraordinary" (claim 24),
"rarely" (claim 24),
"most recipient phenotypes" (claim 24),
"most common" (claim 24),
"long term" (claim 25), "extraordinary" (claim 25).
Claim 1 recites “the long-term storage,” “the required antigen selection level,” "the sufficiency..." and "the excessive accumulation," each of which lacks clear antecedent basis, which is to say that it is not clear which previously recited claim element is referred to by the recited "the..." If antecedent is intended, that antecedent must be instantiated earlier in the same claim or in a parent claim from which the claim depends directly or indirectly. Antecedent may not be found in another claim from which the claim does not depend. If no antecedent is intended then possibly such instances should instead recite "a" or "an," indicating instantiation of the element as opposed to reference to a previous instance. Claims 2-3, 11-12 are rejected similarly regarding one or more instances of "the..." lacking clear antecedent in each claim, as follows:
claim 2: "the formation...," "the possibility...," "the presence..." and "the absence..."
claim 3: "the... rules..." and "the matching process"
claim 11: "the... requirements"
claim 12: "the decision...," "the... recommendation...," "the... scores" and "the... difference"
claim 13: "the value...," "the... factor" and "the... unit"
claim 14: "the required demographic, phenotype, antibody information" and "the patient's transfusion risk group"
claim 16: "the presence of relevant alloantibodies and autoantibodies"
claim 17: "the capability..." and "the match results..."
claim 18: "the match score code," "the degree of matching..."
claim 20: "the choice factor," "the deviation..." and "the number..."
claim 21: "the storage method, expiration date, and phenotype usage type..."
claim 22: "the purpose...," "the requested phenotype...," "the excessive accumulation..."
claim 23: "the 16...," "these unique phenotypes...," "the pairs...," "the ABO system...," "the Kell system...," "the Fya or Fyb antigens...," "the Duffy system..."
claim 25: "the recommended storage method...".
Relatedly, the following recitations render their claims indefinite for lack of recitation of a required grammatical article, e.g. "a," "the," etc. For lack of this required article, the relationships are unclear as to instantiation, later instance, and relationship to other instances. These recitations are: "unit additional factors" (claim 13), "patient donor priority factor" (claim 13), "patient donor match" (claim 15) and "patient unit selection score." Also, the relationship is unclear between "priority factors" (claim 12) and "patient donor priority factor" (claim 13).
In claim 8, the relationship is unclear between the "transfusion risk group five" of claim 8 and the similar recitations of claim 3 at least because it is unclear which of the claim 3 groups is "group five."
Claim 12 recites “...comparing the patient unit match scores and difference in priority factors...” in which the relationships are unclear among "scores," "difference" and "factors." Possibly "difference" should be plural.
In claim 15, the relationship is unclear between "demographic, phenotype, antibody information" and the similar but not identical recitation of claim 1.
In claim 16, the recited "additional patient donor matching logic" renders the claim indefinite for lack of clear antecedent regarding the recited "additional."
In claim 17, a lack of clear grammatical structure renders the claim indefinite at least for lack of clear relationships between the claim's verbs.
In claim 19, the relationship is unclear between "a patient unit selection score" and the similar element of claim 17. Possibly "the" should be recited in claim 19.
In claim 23, the following abbreviations require definitions in the claim: "Cle, E/e, Fy8/Fyb, Jk8/Jkb, S/s, M/N."
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 1-3, 8 and 10-25 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 1-3, 8 and 10-25); which falls within one of the categories of statutory subject matter. [Step 1: Yes].
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Mathematical concepts recited in instant claims 1, 12-13, 17-20 and 22, include the terms which are mathematical concepts:
“high probability of finding .. red blood cel(s)” (claims 1 and 22);
“match score(s)” (claims 12 and 18);
“patient compatible units are ordered by the value of the patient unit priority factor which is calculated by adding unit additional factors to patient donor priority factor; the highest-ranking available unit is recommended for the patient” (claim 13);
“capability to quantitatively define the match results of patient donor compatibility … calculate patient unit selection score” (claim 17);
“priority factor which is a numerical measurement … patient unit selection score” (claim 19); and
“defines the number of antigen rules” (claim 20).
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one having ordinary skill in the art. Thus, the recited terms corresponds to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include:
“recommending specific blood product units/donors for transfusion candidates … arrange patients into groups indicating the required antigen selection level by phenotype for optimal donor match, explaining which demographic, medical, and laboratory information should be considered, and assessing the sufficiency of a patient's available blood typing information … arrange donors by phenotype enabling optimization of unit selection for cryopreservation, and for maintaining an equilibrium between a high probability of finding requested red blood cell phenotypes and the excessive accumulation of red blood cell units that go unclaimed and ultimately expire” (claim 1);
“classify patients into groupings” (claims 2-10 and 22-24);
“determine if patient's blood typing information is sufficient to perform donor matching” (claim 11);
“evaluate the decision of a manually completed blood unit selection against the invention recommendation” (claim 12);
“measure its quality by comparing the patient unit match scores and difference in priority factors” (claim 12);
“consider additional patient donor matching logic for immunohematological conditions” (claim 16); and
“determine the recommended storage method of red blood cell units using phenotype classification” (claim 25).
Under the BRI, the recited limitations are mental processes because a human mind is sufficiently capable: evaluate data to make a recommendation; arrange data into groups; explain data; assess/determine sufficiency of information; classify patients into groupings according to a combination of data; evaluate a decision; compare scores obtained; consider additional information and determine a storage method.
Dependent claims 17-20 recite further details about the measurement of the priority factor and matching score; not reciting any additional non-abstract elements; all reciting further aspects of the information being analyzed, the manner in which that analysis is performed.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The instant claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Instant claims 1, 12-15, and 21 recite additional elements that are not abstract ideas:
“classification scheme” (claim 1);
“determine and measure patient unit compatibility and rank patient compatible units” (claim 13);
“determine and measure patient donor compatibility is based on the required demographic, phenotype, antibody information as specified by the patient's transfusion risk group” (claim 14),
“determine and measure patient donor match based on all available demographic, phenotype, antibody information” (claim 15); and
“determine and measure unit specific factors is based on the storage method, expiration date, and phenotype usage type” (claim 21).
In light of the instant specification, the recited limitations in these claims are interpreted to require the use of a computer by reciting “matching algorithm associated with the application of the classification scheme” [236]. The use of a computer is broadly interpreted and not actually described in the claims or specification. Under BRI, the “algorithm” recitation in the disclosure of this instant application amounts to applying computer methods. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions.
The described claims relate to computers or further aspects of the information being analyzed by computers, and do not describe any specific computational steps by which the computer performs or carries out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions. Claims directed to “outputting” data of whether “the sample contains the presence or absence of the complex genetic variant”” read on receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321
There are no additional limitations to indicate that the claimed computer, processor, or computer readable medium require anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)). None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed, the manner in which that analysis is performed, or the mathematical operations performed on the information. [Step 2A Prong Two: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of the 35 USC § 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claims 1, 12-15, and 21 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
The use of a classification scheme to determine donor/blood product compatibility is well-understood, routine and conventional (Carman et. al. “CE: a review of current practice in transfusion therapy” AJN The American Journal of Nursing 118(5): 36-44 (2018) – pg. 40 col. 1 para. 2)
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h). [Step 2B: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For these reasons, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the abstract idea, so instant claims 1-3, 8 and 10-25 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 11, 14-16, 21-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milkins "Guidelines for pre‐transfusion compatibility procedures in blood transfusion laboratories." Transfusion Medicine 23(1):3-35 (2013) as cited on the attached Form PTO-892.
Independent claim 1 recites “a method for blood transfusion information analysis for the purpose of recommending specific blood product units/donors for transfusion candidates including those of complex cases, rare blood types and emergent situations to achieve: a better patient - donor match, prevention of alloimmunization and more effective prevention of transfusion hemolytic reactions, as well as improved optimization of the long-term storage of red blood cell units; a classification scheme to be used to arrange patients into groups indicating the required antigen selection level by phenotype for optimal donor match, explaining which demographic, medical, and laboratory information should be considered, and assessing the sufficiency of a patient's available blood typing information; determination and measurement of patient donor compatibility, measurement and comparison of unit selection decisions; a classification scheme to be used to arrange donors by phenotype enabling optimization of unit selection for cryopreservation, and for maintaining an equilibrium between a high probability of finding requested red blood cell phenotypes and the excessive accumulation of red blood cell units that go unclaimed and ultimately expire”. Dependent claim 14 recites “to determine and measure patient donor compatibility is based on the required demographic, phenotype, antibody information as specified by the patient's transfusion risk group”. Dependent claim 15 recites “to determine and measure patient donor match based on all available demographic, phenotype, antibody information”. Dependent claim 16 recites “to consider additional patient donor matching logic for immunohematological conditions such as chimerism, and the presence of relevant alloantibodies and autoantibodies”. Dependent claim 21 recites “to determine and measure unit specific factors is based on the storage method, expiration date, and phenotype usage type”.
Milkins teaches the guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories (pg. 3 title); wherein recommendations are made for selection of blood (i.e. reading on specific blood product units/donors for transfusion candidates) (pg. 19 col.1 “Selection of blood”); which involves classifying patients into 11 recommended blood groups for transfusion explaining which demographic, medical, and laboratory information should be selected for each group (pg. 19 col. 1 “ABO selection”; pg. 19 col. 2 “D selection”; pg. 19 col. 2 “Females of child-bearing potential”; pg. 20 col. 1 “Patients with red cell alloantibodies of likely clinical significance”; pg. 20 col. 1 “Patients with known alloantibodies of likely clinical significance to low-frequency antigens, e.g. anti-Wra”; pg. 20 col. 1 “Patients with alloantibodies considered unlikely to be of clinical significance”; pg. 20 col. 1 “Patients with autoimmune haemolytic anaemia”; pg. 20 col. 2 “Panagglutination”; pg. 20 col. 2 “Massive blood transfusion”; pg. 21 col. 1 “Foetal transfusions”; pg. 21 col. 1 “Transfusions for neonates and infants up to 4months post-delivery”; pg. 21 col. 2 “Patients with sickle cell disease”; pg. 21 col. 2 “Other transfusion-dependent patients (excluding those with sickle cell disease”); wherein some of the objectives are: to minimize the risk of ed cell alloimmunization (pg. 21 col. 2 para. 7.19.1); to prevent risks for autoimmune haemolytic anaemia including reactions caused by alloantibodies (pg. 20 col. 2 para. 7.13.5); wherein patient’s phenotype is compared with the respective compatible donor (i.e. determination and measurement of patient donor compatibility, measurement and comparison of unit selection decisions) (pg. 15 col. 2 Table 4); wherein a compatibility tag contains the patient’s information regarding blood typing (i.e. assessing the sufficiency of a patient's available blood typing information) (pg. 22 col. 1 para. 7.21.2); wherein the combination of screening panels increases the probability of being able to identify a mixture of antibodies required for compatibility (i.e. maintaining an equilibrium between a high probability of finding requested red blood cell phenotypes) (pg. 15 col. 1 para. 6.33); wherein guidelines include recommendation to avoid expired red cells (pg. 19 col. 1 para. 7.6.5); which anticipates claims 1,14-16 and 21.
Dependent claim 2 recites “to classify patients into groupings to optimize donor selection to prevent the formation of unexpected antibodies so that the patient does not transition to an alloimmunized state, and to minimize the possibility of hemolytic transfusion reactions; this method combines relevant demographics and medical conditions taking into consideration: a) clinical criteria: blood diseases, long-term transfusion therapies, and drugs that cause nonspecific red blood cell agglutination, b) laboratory conditions: the presence of specific and multispecific antibodies, and c) demographics: woman's age in the absence of relevant clinical and laboratory conditions”. Milkins teaches principles of selection of red cells for transfusion to reduce risks (pg. 17 col. 1 para. 7.1.1); which involves classifying patients into recommended blood groups for transfusion explaining which demographic, medical, and laboratory information (i.e. blood diseases) should be selected for each group (pg. 19 col. 1 “ABO selection”; pg. 19 col. 2 “D selection”; pg. 19 col. 2 “Females of child-bearing potential”; pg. 20 col. 1 “Patients with red cell alloantibodies of likely clinical significance”; pg. 20 col. 1 “Patients with known alloantibodies of likely clinical significance to low-frequency antigens, e.g. anti-Wra”; pg. 20 col. 1 “Patients with alloantibodies considered unlikely to be of clinical significance”; pg. 20 col. 1 “Patients with autoimmune haemolytic anaemia”; pg. 20 col. 2 “Panagglutination”; pg. 20 col. 2 “Massive blood transfusion”; pg. 21 col. 1 “Foetal transfusions”; pg. 21 col. 1 “Transfusions for neonates and infants up to 4months post-delivery”; pg. 21 col. 2 “Patients with sickle cell disease”; pg. 21 col. 2 “Other transfusion-dependent patients (excluding those with sickle cell disease”); wherein some of the objectives are: to minimize the risk of ed cell alloimmunization (pg. 21 col. 2 para. 7.19.1); to prevent risks for autoimmune haemolytic anaemia including reactions caused by alloantibodies (pg. 20 col. 2 para. 7.13.5); wherein patient’s phenotype is compared with the respective compatible donor (i.e. determination and measurement of patient donor compatibility, measurement and comparison of unit selection decisions) (pg. 15 col. 2 Table 4); wherein blood/donor selection includes requirements based on demographics (col. 19 col. 1 para. 7.6.4); wherein some clinical conditions required long-term transfusion therapies (pg. 12 col. 2 para. 4.8.4); wherein some guidelines are applicable to patients with cold haemagglutinin disease (i.e. disease that cause blood agglutination) (pg. 16 col. 2 para. 6.5.4) and testing for specific antibodies (pg. 18 col. 2 para. 7.5.4); wherein compatibility tags are generated in the transfusion laboratory and attached to the blood component bags; containing the core patient identifiers and blood component details as well as additional information to support the safe administration of blood (pg. 32 col. 1 para. 6) and phenotype information (pg. 22 col. 1 para. 7.21.2); wherein the correct compatibility tag must be attached to the correct unit (pg. 22 col. 2 para. 7.21.6); which anticipates claim 2.
Dependent claim 3 recites “to classify a patient into one of seven (7) transfusion risk groups where each group has its own required blood typing criteria; wherein the group is selected from: a) four transfusion risk groups are defined according to the required antigen matching rules, b) two groups consider unexpected specific antibodies in the matching process”. Milkins teaches the classification of patients into 11 recommended blood groups for transfusion explaining which risk, demographic, medical, and laboratory information (i.e. blood disease and blood type recommendation) should be selected for each group (pg. 19 col. 1 “ABO selection”; pg. 19 col. 2 “D selection”; pg. 19 col. 2 “Females of child-bearing potential”; pg. 20 col. 1 “Patients with red cell alloantibodies of likely clinical significance”; pg. 20 col. 1 “Patients with known alloantibodies of likely clinical significance to low-frequency antigens, e.g. anti-Wra”; pg. 20 col. 1 “Patients with alloantibodies considered unlikely to be of clinical significance”; pg. 20 col. 1 “Patients with autoimmune haemolytic anaemia”; pg. 20 col. 2 “Panagglutination”; pg. 20 col. 2 “Massive blood transfusion”; pg. 21 col. 1 “Foetal transfusions”; pg. 21 col. 1 “Transfusions for neonates and infants up to 4months post-delivery”; pg. 21 col. 2 “Patients with sickle cell disease”; pg. 21 col. 2 “Other transfusion-dependent patients (excluding those with sickle cell disease”); wherein previous transfusions or pregnancy may may stimulate the production of unexpected antibodies against red cell antigens (i.e. reading on two groups consider unexpected specific antibodies in the matching process ) (pg. 7 col. 2 para. 3.7.1); wherein the specificity of controls should be reviewed against the antigen profile of any new lot of screening cells (i.e. reading on antigen matching) (pg. 14 col. 1 para. 5.4.7); which anticipates claim 3.
Dependent claim 11 recites “to determine if patient's blood typing information is sufficient to perform donor matching. This is determined by evaluating patient's available phenotype information against the patient's transfusion risk group antigen requirements”. Milkins teaches compatibility tags generated in the transfusion laboratory and attached to the blood component bags; containing the core patient identifiers and blood component details as well as additional information to support the safe administration of blood (pg. 32 col. 1 para. 6) and phenotype information (pg. 22 col. 1 para. 7.21.2); wherein the correct compatibility tag must be attached to the correct unit (pg. 22 col. 2 para. 7.21.6); which anticipates claim 11.
Dependent claim 22 recites “to classify donor phenotypes into five (5) phenotype usage type categories, each which describes how red blood cell units of that category should be stored and managed for optimal blood bank operations for the purpose of maintaining a blood bank long-term storage equilibrium between a high probability of finding red blood cells with the requested phenotype and the excessive accumulation of red blood cells that go unclaimed and ultimately expire”. Milkins teaches detailed instructions for storage of samples including working limits, time frame before sample is unfit for use (pg. 8 col. 2 para. 3.8) and instructions for manual separation of plasma for storage with adequate labels to ensure integrity of samples (pg. 8 col. 2 para. 3.8.3); wherein the combination of screening panels increases the probability of being able to identify a mixture of antibodies required for compatibility (i.e. maintaining a blood bank long-term storage equilibrium between a high probability of finding red blood cells with the requested phenotype) (pg. 15 col. 1 para. 6.33); wherein guidelines include recommendation to avoid expired red cells (pg. 19 col. 1 para. 7.6.5); which anticipates claim 22.
Dependent claim 24 recites “to classify donor phenotypes in an extraordinary category which are rarely used because they are not compatible with most recipient phenotypes, however, they may be required for patients who are alloimmunized to most common antigens”. Milkins teaches the guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories (pg. 3 title); wherein recommendations are made for selection of blood (i.e. reading on specific blood product units/donors for transfusion candidates) (pg. 19 col.1 “Selection of blood”); which involves classifying patients into 11 recommended blood groups for transfusion explaining which demographic, medical, and laboratory information should be selected for each group (pg. 19 col. 1 “ABO selection”; pg. 19 col. 2 “D selection”; pg. 19 col. 2 “Females of child-bearing potential”; pg. 20 col. 1 “Patients with red cell alloantibodies of likely clinical significance”; pg. 20 col. 1 “Patients with known alloantibodies of likely clinical significance to low-frequency antigens, e.g. anti-Wra”; pg. 20 col. 1 “Patients with alloantibodies considered unlikely to be of clinical significance”; pg. 20 col. 1 “Patients with autoimmune haemolytic anaemia”; pg. 20 col. 2 “Panagglutination”; pg. 20 col. 2 “Massive blood transfusion”; pg. 21 col. 1 “Foetal transfusions”; pg. 21 col. 1 “Transfusions for neonates and infants up to 4months post-delivery”; pg. 21 col. 2 “Patients with sickle cell disease”; pg. 21 col. 2 “Other transfusion-dependent patients (excluding those with sickle cell disease”); which anticipates claim 24.
No prior art has been applied to the following claims
No prior art is applied to claims 8, 10, 12-13, 17-20, 23, and 25.
The prior art does not teach the instant combination of particular steps/elements regarding on the specific transfusion risk groups described in said claims; and it is not clear that any combination of art would have rendered the claims obvious. Therefore, the claims are interpreted as free of the prior art.
Art made of record but not relied upon
The following art is listed on the attached form 892 and made of record but not relied upon:
Carman et. al. “CE: a review of current practice in transfusion therapy” AJN The American Journal of Nursing 118(5): 36-44 (2018) –teaching blood products that are commonly transfused; discuss potential complications of transfusion, as well as their associated signs and symptoms; and outline current recommendations for transfusion therapy that are widely supported in the medical and nursing literature (pg. 36 para. 1); wherein typing and compatibility is described per blood type (pg. 40 col. 1 para. 2) along with complications of transfusion therapy (pg. 40 col. 2 para. 1).
Conclusion
No claims are allowed.
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/F.F.L./Examiner, Art Unit 1685
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686