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 .
Election/Restriction
Applicant's election without traverse of Group I (claims 1-10) in the reply filed on 08/11/2025, is acknowledged. Claims 22 and 23 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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's election of Group I (claims 1-10), Species A (claim 5), and Species B (claim 9) in the reply filed on 08/11/2025 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 § 818.03(a)).
Claims 4, 7, 8, and 11-20 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Status of Claims
Claims 1-20 are pending.
Claims 1-3, 5, 6, 9, and 10 are presently under examination.
Claims 4, 7, 8, and 11-20 are withdrawn.
Priority
The instant application does not claim the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to any prior applications. Accordingly, the effective priority date for the instant application is the filing date of 09/09/2021.
Advisory Notice
No IDS has been filed in the instant case. Applicant is reminded of the requirements of 37 CFR 1.56 and Li Second Family Limited Partnership v. Toshiba Corp., 56 USPQ2d 1681 (Fed. Cir. 2ooo); and McKesson Information Solutions, Inc. v. Bridge Medical, Inc. 487 F.3d 897, 913. (Fed.Cir.2007). If Applicant is aware of any materially relevant prior art, it should be submitted in an IDS for consideration.
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, 5, 6, 9, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Step 1
The instantly claimed invention (claim 1 being representative) requires performing a series of process steps. As such, the claims fall into one of the four statutory categories.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 1, the following limitations constitute the abstract idea for the following reasons:
performing Correlated Multiphasic Analysis (CMA) of autosomal DNA (atDNA) matches, independent of any specific testing provider or tabulating mechanism.
Mental Processes
In this case, the claimed performing step is not limited to any particular acts or operations to achieve the claimed functions. Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the above step encompasses the observation, collection, and manipulation of data, which may be practically performed in the human mind of a scientist. This position is further supported by the instant specification, which teaches CMA performed by applying various mathematical operations [pages 5-10]. Applicant is reminded that the Office's eligibility guidance does not set limit on the number of calculations that can or cannot be performed mentally. MPEP § 2106.04(a)(2)III. For these reasons, the above steps fall within the “mental processes” grouping of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim includes any additional steps/elements that integrate the recited judicial exception into a practical application of the exception.
In this case, the claims do not recite any additional steps/elements that integrate the abstract idea into a practical application. [Step 2A, Prong 2: NO].
MPEP 2106.04(d)(1) lists the following considerations for evaluating whether additional elements integrate a judicial exception into a practical application:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to affect 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).
Additionally, the courts have also identified limitations that did not integrate a judicial exception into a practical application:
Merely reciting a phrase such as "apply it" (or an equivalent) along with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP 2106.05(f);
Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP 2106.05(g); and
Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h).
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, as set forth above, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s). Notably, the claims do not even require the use of a computer processor for performing the claimed analysis. However, the courts have also explained that the use of generic computer elements do not alone transform an otherwise abstract idea into patent-eligible subject matter. See DDR Holdings (Fed. Cir. 2014) [Step 2B: NO].
Dependent Claims
Dependent claims 2-3, 5, 6, 9, and 10 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claims 2, 3, 5, 6, 9, 10, these claims all further limit the specificity of the abstract idea set forth above and/or recite additional process limitations that are also directed to a mental process or mathematical relationship (e.g. selecting data based on criteria, compounding based on a logical intersection, tallying data). Accordingly, these claims are also directed to abstract ideas for reasons set forth above (Step 2A, prong 1). Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 101- Lack of Utility
Claims 1-3, 5, 6, 9, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a substantial asserted utility or a well-established utility.
For an invention to be “useful” it must satisfy the utility requirement of section 101. The USPTO’s official interpretation of the utility requirement provides that the utility of an invention has to be (i) specific, (ii) substantial and (iii) credible. See MPEP § 2107 and Fisher, 421 F.3d at 1372, 76 USPQ2d at 1230.
In this case, the claims lack a specific and/or substantial utility for the following reasons. The claimed method recites a “process for performing CMA of autosomal DNA matches” (in the preamble) but does not even recite a single positive process limitation for achieving the purpose of the preamble (see also rejection under 35 USC 112(b) below). Accordingly, the claimed invention is not associated with any particular real-world context of use and the method as claimed would require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use. Accordingly, the claimed method does not define "substantial utilities". In addition, the claimed invention is deemed to be "inoperative" (i.e., it does not operate to produce the results claimed by the patent applicant) for the following reasons. In particular, the claimed invention does not require any particular computer, computer code, or programming logic for performing the claimed functions. Therefore, the claimed method is deemed to be inoperable since there is no defined computer or device for processing the claimed data. For the above reasons, the claimed invention is not supported by a specific and/or substantial utility.
Claims 1-3, 5, 6, 9, and 10 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, since the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention. [See MPEP 2106.02].
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.
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 1-3, 5, 6, 9, and 10 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 is/are also rejected due to said dependency.
Claim 1 recites (in the preamble) “A process for performing Correlated Multiphasic Analysis (CMA) of autosomal DNA (atDNA) matches, independent of any specific testing provider or tabulating mechanism.” The preamble is problematic for the following reasons. (1) The claimed process as written confusingly does not “comprise” any positive process limitations for actually achieving the purpose of the preamble but merely recites an intended use limitation. Applicant is reminded that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process (as is the case here) [See MPEP 2111.02], and that no patentable distinction (no limit on the claim scope) is made by an intended use or result recitation. Clarification is requested via amendment.
(2) It is unclear as to the metes and bounds of “Correlated Multiphasic Analysis”. A review of the specification does not provide any limiting definition. As a result, the claims fail to provide “a clear-cut indication of the scope of the subject matter embraced by the claim” by generically encompassing all known mathematical and/or computational techniques known in the art that. Therefore, the claim(s) is/are indefinite for failing to point out the requisite computational acts or operations that are included or excluded by the claim language, such that the artisan would know how to avoid infringement. Clarification is requested via amendment.
(3) It is unclear as to the metes and bounds of the terms “testing provider” and “tabulating mechanism”. A review of the specification does not provide any limiting definitions that would serve to clarify the scope, and the body of the claim does not use, define, or recite any of these limitations. Clarification is requested via amendment.
(4) As result of the above issues, the claim is also rejected under 35 USC 112(b) for missing essential matter since it fails to interrelate the essential elements of the invention. See also MPEP 2172.01. In particular, the essential matter that is missing includes positively recited active method steps that are required to practice the invention and achieve the intended result set forth in the preamble. Clarification is requested via amendment.
Claim 2 recites “The process of claim 1, where the atDNA matches of a Target Individual are logically compounded with the matches of other test subjects via unary operations including, but not limited to: intersection, union, and complementation.” In this case, parent claim 1 does not mention or recite any “Target Individual”. Accordingly, there is lack of antecedent basis for “the atDNA matches of a Target Individual”. In other words, the claim is relying upon information and/or claim elements that have not been previously introduced or obtained. Correction is requested via amendment.
Claim 3 recites “The process of claim 1, whereby additional test subjects are selected from the atDNA matches of the Target Individual based on criteria including, but not limited to: a) the ancestral family line shared by the Target Individual and test subject, b) the amount of atDNA linkage shared by the Target Individual and test subject, c) test subjects with extensive family trees verified by research and/or DNA, d) test subjects whose shared linkage with the Target Individual ranks them at the top of their genetic complex, e) test subjects whose atDNA may contain specific markers for biological traits or genetic predispositions relevant to epidemiology or genetic counseling.” This above “whereby” clause is problematic for the following reasons. Firstly, the phrase “whereby additional test subjects are selected” suggests that test subject were previously selected in parent claim 1. However, parent claim 1 does not recite any positive process limitations at all (and definitely not any steps for selecting test subjects), nor does it recite any test subjects. Therefore, it is unclear in what way claim 3 further limits the subject matter of parent claim 1. Clarification is requested via amendment. Secondly, there is lack of antecedent basis for “the atDNA matches of the Target Individual” because parent claim 1 does not mention or recite any “Target Individual”. In other words, the claim is relying upon information and/or criteria that has not been previously introduced or obtained. Correction is requested via amendment. Clarification is requested via amendment.
Claim 5 recites “The process of claim 1, whereby the analytic core set is cross-referenced against a roster of test subjects to generate a CMA Classification consisting of letter-name identifiers associated with each test subject.” In this case, there is no previous mention of any “analytic core” in parent claim 1. Accordingly, there is lack of antecedent basis for this limitation. Correction is requested via amendment. In addition, it is unclear as to the metes and bounds of the term “analytic core”. A review of the specification does not provide any limiting definition that would serve to clarify what structural limitation is intended. The specification teaches scripts and subroutines associated for populating core populating the analytic core set of the Summary Module [Figure 9]. However, examples are not limiting definitions and this does not clarify what structural limitation is intended by this term. Clarification is requested via amendment.
Claim 6 recites “The process of claim 1, whereby the CMA Classification of each element of the ACS is parsed to assign each element to a genetic complex (C).” In this case, there is no previous mention of any “CMA classification” in parent claim 1. Accordingly, there is lack of antecedent basis for this limitation. Correction is requested via amendment. As a result, it is also unclear in what way the above “whereby” clause further limits the subject matter of claim 1. Clarification is requested via amendment.
Claim 9 recites “The process of claim 1, whereby genetic complexes are tallied in a Table of Complexes (ToC) consisting of MRCA couples taken from the Target Individual's pedigree alongside their "generation number" - the number of generations each MRCA couple is removed from the Target Individual. In this case, there is no previous mention of any “genetic complexes” or “the Target Individual” in parent claim 1. Accordingly, there is lack of antecedent basis for these limitations. Correction is requested via amendment. As a result, it is also unclear in what way the above “whereby” clause further limits the subject matter of claim 1. Clarification is requested via amendment.
Claim 10 recites “The process of claim 1, wherein parsing the CMA Classification of an element of the ACS entails comparing the generation numbers of the MRCA couples of each letter-name in the CMA Classification and assigning that element of the ACS to the nominal genetic complex defined by the MRCA couple with the greatest generation number. In this case, there is no previous step of “parsing” anything or any mention of “the CMA Classification” in parent claim 1. Accordingly, there is lack of antecedent basis for these limitations. Correction is requested via amendment. As a result, it is also unclear in what way the above “wherein” clause further limits the subject matter of claim 1. Clarification is requested via amendment.
Claim rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3, 5, 6, 9, and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In particular, for reasons discussed above, each of the instantly rejected claims refers to particular steps and/or elements that are not previously recited in parent claim 1. Accordingly, these claims each fail to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Examiner' s Comment
In view of the indefiniteness and lack of clarity in the instant claims, as set forth in the 35 USC 112(b) rejections above, the Examiner has had difficulty in properly interpreting instant claims. However, to avoid piecemeal prosecution and to give applicant a better appreciation for relevant prior art if the claims are redrafted to avoid the 35 USC 112(b) rejections, the Examiner has broadly interpreted the claims as a method of performing multiphasic analysis for purposes of applying the following prior art rejections.
Claim Rejections - 35 USC § 102 or 103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 102(b) as being anticipated by or, in the alternative, under 35 U.S.C. 103(a) as being obvious over Park et al. (Park et al. BMC Genomics 2013, 14:191, pp.1-9).
Park teaches a method of analyzing whole exome sequencing. Regarding claim(s) 1, Park teaches performing multiphasic analysis of copy number variation (CNV), linkage, and single nucleotide variation (SNV) of whole exome sequencing (WES) data for the efficient discovery of DNA mutations [Abstract]. In particular, the SNV analysis includes matched autosomal SNVs (which reasonably suggests atDNA) [Results, page 2, col. 2, page 3, col. 1 and 2]. Accordingly, Park reasonably teaches or suggests the claimed process as the instant claims do not recite any positive process limitations for actually performing the claimed steps.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619