DETAILED ACTION
This application is being examined under pre-AIA first-to-invent provisions.
Status of claims
Canceled:
none
Pending:
1-20
Withdrawn:
none
Examined:
1-20
Independent:
1 and 19
Allowable:
none
Rejections applied
Abbreviations
x
112/2nd Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/2nd "Means for"
BRI
Broadest Reasonable Interpretation
112/1st Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
x
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/1st
35 USC 112, 1st para. and similarly for 112, 2nd para., etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 5/14/2021 filing receipt, this application claims priority to no earlier than 3/8/2012. All claims have been interpreted as being accorded this priority date.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications. 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
Claims 1 and 19 are 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
1, 19
for each size of a plurality of sizes:
Probably the colon should be a comma and should not be followed by a newline
Claim rejections - 112/2nd
The following is a quotation of 112/2nd:
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 14-15 and 19-20 are rejected under 112/2nd, 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 112/2nd as indefinite:
Claim
Recitation
Comment (suggestions in bold)
14-15
massively
The recited "massively" is a term of relative or vague degree or form of association, neither defined in the specification ([3, 126]) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.)
15
further comprising performing massively parallel
sequencing
The relationship is unclear between claim 15 and the "receiving" step of claim 1.
19
...instructions that when executed control a computer system...
Claim 19 is rejected as directly reciting a machine and a process in the same claim. A claim to a machine, e.g. here a "computer readable medium," cannot directly recite a process step such as "control..." MPEP 2173.05(p).II pertains. It would suffice to add some form of "configured to" before the process step so as properly focus on claimed structure. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
19
to analyze a
plasma sample of an organism
The subsequently recited steps begin with "receiving ... sequence reads," and the recited "analyze a plasma sample" appears to refer to a wet assay step preceding receiving reads. The relationship is unclear between the recited "to analyze..." and the recited "receiving..." Depending on resolution of this rejection, a 112/1st written description rejection also may apply regarding software control of the wet assay, e.g. control of the sequencing.
Claim rejections - 112/4th
The following is a quotation of 112/4th:
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 12-14 are rejected under 112/4th as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend. Claim 1 recites only "receiving" the results of sequencing which does not occur as part of the method. Therefore, claims 12-14 recite product-by-process limitations, and it is not clear that their recitations affect the structure of the received data. Therefore, it is not clear that their recitations further limit the claims. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements. MPEP 608.01(n).III pertains. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 is incorrect, any correction of the statutory basis 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 35 USC 103 which forms the basis for all obviousness rejections set forth in this office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 1-9 and 17-20
Claims 1-9 and 17-20 are rejected under 35 USC 103(a) as unpatentable over Jiang (as cited on the 12/29/2021 IDS #327) in view of Chan (as cited on the 12/29/2021 IDS #327) and Fan (as cited on the 12/29/2021 IDS #327).
Regarding claim 1, Jiang teaches measuring cell-free DNA size distribution as a "ratio in relative abundance of 400 versus 100 bp PCR products of a housekeeping gene..." (§"DNA strand integrity analysis;" and entire document), characterizing that distribution as "DNA integrity index was determined" (§"DNA strand integrity analysis;" and entire document), comparison to a reference as "comparison of the difference in plasma DNA integrity index between HNSCC patients and non-HNSCC control groups" (§"Statistical analysis;" and entire document) and cancer classification as "using plasma DNA strand integrity index as a diagnostic" (§"Statistical analysis;" and entire document).
Fan teaches paired-end sequencing (Fan: title; and entire document).
Chan teaches "PCR assays to amplify different-sized amplicons ... " (Chan: p. 89, §"SIZE DISTRIBUTION ANALYSIS OF TOTAL PLASMA DNA IN PREGNANT WOMEN;" all of §"Results;" and entire document).
Claim 1 recites "size," which reads on at least "range" "length."
Claim 1 recites "a first parameter," which reads on at least a relative amount of small versus large fragments."
Chan teaches "median relative concentration" (Chan: p. 90, §"SIZE DISTRIBUTION OF FETAL-DERIVED DNA IN MATERNAL PLASMA;" all of §"Results;" and entire document), in which the median relative concentration is one example statistical result of the analysis of Chan.
Chan teaches "the absolute concentration of DNA determined in the PCR system with the shortest amplicon used (105 bp for the leptin gene and 107 bp for the SRY gene)" (Chan: p. 90, §"QUANTITATIVE PCR FOR FRAGMENT SIZE ANALYSIS;" all of §"Results;" and entire document), in which the recited calibration value and its application to the data read on the "absolute" (i.e. calibrated) values of Chan.
Chan teaches "the relative concentration for each amplicon size was calculated such that the size distribution of DNA in each individual could be compared" and "relative to the 105 bp amplicon for leptin and to the 107 bp amplicon for SRY" (Chan: p. 90, §"QUANTITATIVE PCR FOR FRAGMENT SIZE ANALYSIS;" Fig. 1B y-axis label and caption; all of §"Results;" and entire document).
Chan teaches "relative concentration" and the binned "fractional concentrations" of Figs. 1-2 (Chan: p. 90, §"QUANTITATIVE PCR FOR FRAGMENT SIZE ANALYSIS;" all of §"Results;" and entire document).
The art is applied to claims 19-20 as described in the rejection of claim 1 and as follows. The recited computer product and processor are taught by Chan as "software" and its inherent environment (Chan: p. 89, 2nd col., 1st para.; and entire document).
The art is applied to claims 2-9 and 17-18 as described above for claim 1 and as further discussed below.
Regarding claims 2-5, Fan teaches fragments which naturally occur according to each of the recited limitations. Thus, the claims read on Fan.
Regarding claim 6, Jiang teaches cancer and "control subjects" (Jiang: abstract; and entire document).
Regarding claim 7, Jiang teaches a "ratio in relative abundance of 400 versus 100 bp PCR products" (Jiang: p. 2674; and entire document).
Regarding claim 8-9, repetition of previously recited steps would have been prima facie obvious (MPEP 2143 E., Example 9 pertains).
Regarding claim 17, Fan teaches application to humans (Jiang: title and abstract; and entire document).
Regarding claim 18, Fan teaches the recited number of fragments (Fan: Fig. 1; and entire document).
Combining Jiang and Chang
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the cell-free sequence analysis teaching of Jiang using the related teaching of Chang. As motivation to combine, an advantage taught by Chang of modifying methods such as those of Jiang would have been the teaching of Chang that "...new information on the molecular characteristics of the different DNA species present in maternal plasma may facilitate understanding of the release and elimination of plasma DNA and the future development of new plasma DNA-based markers." (Chang: p. 92, 3rd para.). Thus, PHOSITA would have been motivated to modify Jiang using the above techniques of Chang in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Jiang and Chang are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Chang to the related teaching of Jiang.
Combining Jiang and Fan
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the cell-free sequence analysis teaching of Jiang using the related teaching of Fan. As motivation to combine, an advantage taught by Fan of modifying methods such as those of Jiang would have been the teaching of Fan that "...new information on the molecular characteristics of the different DNA species present in maternal plasma may facilitate understanding of the release and elimination of plasma DNA and the future development of new plasma DNA-based markers." (Fan: p. 92, 3rd para.). Thus, PHOSITA would have been motivated to modify Jiang using the above techniques of Fan in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Jiang and Fan are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Fan to the related teaching of Jiang.
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 1-20 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 1-20: 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 analyzing DNA sequences including the JE elements of "aligning...," "using...," "determining...," "calculating...," "comparing..." and "estimating...," 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.
Claims 19-20 are analyzed similarly.
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 determining an amount, calculating a first value, comparing and estimating a fractional concentration, as well as relationships inherent in recitations as the only supported embodiments.
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.
Regarding inherency of abstract ideas, MPEP 2106.04.II.A.1 includes: "the claims in Alice Corp. v. CLS Bank, 'described' the concept of intermediated settlement without ever explicitly using the words 'intermediated' or 'settlement'" (emphasis added, p. 1). Similarly, inherency can effectively be recitation, as in, for example, "By claiming simply 'crystalline paroxetine hydrochloride hemihydrate' with no reference to how it was produced, SKB effectively claimed 'crystalline paroxetine hydrochloride hemihydrate whether non-naturally occurring or arising through natural conversion.' Claim 1, as issued, therefore combines patentable and unpatentable subject matter, and is invalid under Section 101." (capitalization added, SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1321-33, Fed. Cir. 2004).
In the instant type of data processing claims, the specification is not merely adding background explanation as to how a claimed process works, e.g. a physical process based on, involving or further explained by abstract ideas and natural laws. Rather, the specification is detailing the only disclosed way that a programmer may proceed from the recited inputs to the recited outputs, e.g. through actual performance of the disclosed judicial exceptions (JEs).
Regarding the "Meaning of 'Recites,'" MPEP 2106.04.II.A.1 states:
In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement."
While the "set forth" language approximates explicit recitation, it also is fundamental that all recitation must be interpreted and that to be patent eligible a claim must satisfy 101 according to its properly interpreted scope, e.g. for all embodiments on which the claim reads, e.g. according to any inherency pertinent to a given claim and disclosure accompanying that claim, i.e. consistent with the "described" meaning of "recites" as in the MPEP. Thus, within a BRI, the identified abstract idea elements read on one or more embodiments which only involve manipulation of data. It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim.
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: claims 1 and 19-20: 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? -- law of nature -- MPEP 2106.I and 2106.04
Preliminarily, at this 1st step of the analysis, elements of independent claim 1 are directed to a law relating fragment size distribution to fractional concentration of tumor DNA, including the JE element of "estimating..."
Claims 19-20 are analyzed similarly.
A BRI of the instant claims is analogous to a law of nature as found, for example, in Mayo (as cited in the MPEP above). It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim. It is not clear that the above identified law of nature including the identified elements, taken together and within a BRI, must in all embodiments represent other than a law of nature according to any relevant analysis or case law. Therefore, in answer to the 1st Mayo/Alice question, the above elements are directed to a law of nature.
[Step 2A, 1st prong, natural law: claims 1 and 19-20: 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: [7]).
[Step 2A, 2nd prong: claims 1 and 19-20: 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
Addressing the second Mayo/Alice question, all elements of claims 1 and 19-20 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions:
The recited "receiving" is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input/output elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g), and as exemplified by Jiang (as cited on the 12/29/2021 IDS #327), and generally it is understood that the examples in the reference are well-known and routine.
Data gathering does not impose any meaningful limitation on the judicial exceptions or on how the judicial exceptions are performed. Data gathering is insufficient 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: claims 1 and 19-20: NO]
Summary and conclusion regarding claims 1 and 19-20
Summing up the above analysis of claims 1 and 19-20, each 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 2-18 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.
None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used.
A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double patenting rejections of instant claims 1-20
Instant claims 1-20 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents 11,031,100 (from application 16/913,510); 10,741,270 (from application 15/411,695); 10,297,342 (from application 15/587,662); and 9,892,230 (from application 13/789,553), each in view of Jiang (as cited on the 12/29/2021 IDS #327).
Each reference patent as well as the instant application recite claims which involve receiving and analyzing cell-free DNA sequence reads, aligning the reads to a reference genome and calculating tumor DNA concentration or cancer level.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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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
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