DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
2-9, 13-14, 16-22, 29, 31, 33, 36-39, 42-47
Pending:
1, 10-12, 15, 23-28, 30, 32, 34-35, 40-41
Withdrawn:
10-12, 15, 23-26, 28, 30, 35, 41
Examined:
1, 27, 32, 34 and 40
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
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 4/10/2023 filing receipt, this application claims priority to no earlier than 12/16/2020. All claims have been interpreted as being accorded this priority date.
Restriction/election
Applicant’s 9/17/2025 and 1/26/2026 elections are acknowledged. Because no errors in the restriction requirements were alleged distinctly and specifically, the elections have been treated as elections constructively 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 As listed above, claims are withdrawn as drawn to nonelected inventions pursuant to 37 CFR 1.142(b), and the remaining claims have been examined as listed above.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 requirements are made final.
Objection to the drawings
The 12/12/2022 drawings are objected to for lack of quality and/or readability in some figures, e.g. REPLACEMENT FIG. 4 (e.g. various numerical values) and original FIGs. 5-11 (e.g. various numerical values and axis labels). The drawings are of insufficient quality to permit examination. MPEP 608.02(b).I and generally 608 pertain. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. 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 filing electronically, then possibly higher resolution drawings should be filed as "Supplemental Content." Generally, it may help to replace all figures using supplemental figures. Labels and pertinent features of figures must be legible.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example: regression analysis. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim objections
Claim 34 is objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate.
The following issues are objected to:
Claim
Recitation
Comment
34
34. (Withdrawn - Currently amended) A method for
Should not be identified as withdrawn
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1, 27, 32, 34 and 40 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant 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. 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.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1, 27, 32
...are detected separately
In claim 1, unclear are the grammatical structure of this verb clause as well as its relationship to the rest of the step and claim. The relationship is unclear between "producing...," "the polymorphic genetic loci..." and "are detected..." The same issue occurs in claims 27 and 32.
1, 27
alleles at the specific polymorphic genetic loci
In claim 1, the relationship is unclear between this instance of alleles at that in A1. Same issue in claim 27.
27
predictor variable
The relationship is unclear to the similar recitation in claim 1, step A-4-1. Possibly claim 27 should recite "the predictor variable."
27
a numerical value of more than one or two
Not interpretable at least due to unclear optionality. It appears that it would suffice to recite only "more than one."
27, 32
a data set
The relationship is unclear between the instantiations of "a data set" in claims 1 vs. 27. The same issue recurs with each of the following:
composite variables
a nucleic acid mix sample
primary and secondary contributor nucleic acids
signals
multiple polymorphic genetic loci
one or more composite variables
a numerical group
a secondary contributor component signal intensity indicating
alleles at specific polymorphic genetic loci
a secondary contributor component mix rate
a ratio
Similarly issues to those above occur in claim 32 as well as the following new issues:
primary contributor nucleic acid
27
and the-composite variables
obtained in the following step B-2
The relationship is unclear between this recitation and the rest of the claim at least because this recitation appears to be a grammatical fragment.
27
wherein Equation 2 comprises
In the second instance, probably "...Equation [[2]]3..."
32
The step according to claim 27
The recitation requires but lacks clear antecedent.
32
may contain
Unclear optionality
34
Claim 34 is rejected for each of the same reasons listed above for claims 27 and 32, as applicable.
40
the data set that corresponds to the exclusion condition C1
Requires but lacks clear antecedent
No prior art has been applied to the following claims
No prior art is applied to claims 1, 27, 32, 34 and 40. Neither art in the search results nor art on the IDSs teaches the claim 1 combination of particular calculations, and it is not clear that any combinable art of record would have rendered the claims obvious.
Claim rejections - 101
35 USC 101 reads:
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.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Judicial exceptions (JE) to 101 patentability
Claims 1, 27, 32, 34 and 40 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 1, 27, 32, 34 and 40: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of creating a model function including the JE elements of step A-1, step A-2, step A-3-1, and step A-4-1, each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group) and/or obtaining and comparing intangible data (e.g. Cybersource, Ambry and Myriad CAFC) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI, Digitech, Benson, Flook, Diehr, FuzzySharp, In re Grams and In re Abele all as cited in MPEP 2106).
Instant examples of math concepts include, as examples, "producing one or more composite variables by linearly combining," "a ratio of... signal intensity...," "assigning a ratio... as a probability...," "performing regression analysis..." and obtaining a "model function..."
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle.
It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law.
[Step 2A, 1st prong, abstract idea: claim 1: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another 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).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [240, 253]).
[Step 2A, 2nd prong: claim 1: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
All elements of claim 1 are part of a JE as identified above such that no element is recited which is additional to the identified JE(s). Therefore, no claim recites significantly more than the identified JE(s), and it is not clear that any claim is otherwise sufficiently analogous to controlling case law identifying an example of an eligible claim.
Data gathering does not impose any meaningful limitation on the judicial exceptions or on how the judicial exceptions are performed. Data gathering are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE.
[Step 2B: claim 1: NO]
Summary and conclusion regarding claim 1
Summing up the above analysis of claim 1, viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 27, 32, 34 and 40 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
Inquiries
Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further information is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx.
The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686