DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
In the reply filed 3/20/2026, Applicant elected claims 1-8 without traverse. Applicant also canceled claims 9-11.
Priority
As detailed on the Filing Receipt filed 1/11/2022, the instant application claims foreign priority to as early as 10/25/2021.
Applicant has not supplied an English translation of the listed foreign priority document (CN 202111239725.2; filed 10/25/20121). Applicant may be required to provide an English translation if an intervening prior art reference is applied. See 37 CFR 1.55(g)(3); MPEP 213.04 and 216.
Objection to the Drawings
The Drawings submitted by Applicant (filed 12/29/2021) contain Figures lacking necessary labels, and the significance of the information in constituent graphs is consequently unclear. Figures 3-4 contain graphs lacking axis or unit labels, and the consequently the nature of the represented information is unclear. The Examiner suggests submission of Replacement Sheets bearing additional labels to further clarify represented information.
Objection to the Specification
Applicant is reminded of the proper content of, language and format for an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because of the following informalities:
the abstract contains phrases which can be implied (e.g., “The invention belongs to the field of medical information technology”);
the abstract repeats information given in the title (e.g., “The invention… relates to an evaluation system for evaluating psoriasis and use thereof”); and
the abstract refers to purported merits of the invention (“Compared with other types of psoriasis-related methods and apparatuses, the sensitivity and specificity have obvious advantages”).
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Additionally, the specification is objected to for improper usage of trade names and/or marks used in commerce. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification includes the following terms which reference trade names and/or marks used in commerce:
“eppendorf” and “Eppendorf” (paras. 0021, 0029, 0058, 0071);
“Biovision EZQuant” (paras. 0021, 0029, 0057, 0073, 0074);
“SPSS” (para. 0027, 0029, 0079);
“R” (para. 0027, 0029, 0079);
“biotek” (paras. 0036 and 0080);
“flex station” (paras. 0037 and 0080);
“BD Vacutainer” (para. 0057);
“costar®” (para. 0057);
These terms should be uniformly capitalized and, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Claim Status
Claims 1-8 are pending, and under examination.
Claim Objections
Claim 4 is objected to because of the following informalities:
With respect to claim 4, the recited phrase “and a95% CI” (line 6) should read “and a 95% CI”.
Appropriate correction is required.
Claim Interpretation
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 of ordinary skill in the art (MPEP 2111-2111.01). An applicant may act as their own lexicographer, and if an applicant clearly sets forth a special definition of a claim term in the specification then "the inventor’s intention, as expressed in the specification, is regarded as dispositive” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc).
The claims recite the following terms:
“serum sample without phenotype” (claim 1, line 7; claim 2, line 3; claim 3, line 2; claim 4, line 2);
“phenotyped and cured serum sample” (claim 5, line 2); and
“phenotyped serum sample” (claim 6, lines 2, 7 and 12; claim 7, lines 2, 7 and 12).
The specification reads, in relevant part: “the expression ‘serum sample without phenotype’ refers to a serum sample from people who has not shown clinical symptoms on the skin; ‘phenotyped cured serum sample’ refers to a serum sample from people who has had clinical symptoms on the skin but have been cured; ‘serum sample with phenotype’ refers to a serum sample from people who have shown clinical symptoms” (para. 0030).
The cited claim terms are being interpreted according to definitions set forth in the cited passage of the specification. Specifically, the claim term “serum sample without phenotype” is being interpreted according to the definition provided for the exact term. The claim term “phenotyped and cured serum sample” is being interpreted according to the definition provided for “phenotyped cured serum sample”. The claim term “phenotyped serum sample” is being interpreted according to the definition provided for the term “serum sample with phenotype”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 USC § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-8 are rejected under 35 USC § 112(a) for failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that a joint inventor, at the time the application was filed, had possession of the claimed invention.
With respect to claim 1 and dependents thereof, the following limitations lack adequate support in the written description: “configured to acquire a double-stranded deoxyribonucleic acid (dsDNA) content of a serum sample to be detected” (lines 2-4). This is a functional limitation of the “data acquisition module”, a processor-executable software module.
To provide adequate support for a computer-implemented functional limitation, the specification must discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing (MPEP 2161.01 § I).
The specification describes human-performed methods of acquiring dsDNA content of a serum sample (e.g., para. 0021: “quantitative detection… includes: serum collection… fresh whole blood is collected using a vacuum coagulation-promoting tube”, and so on) but does not describe software implementation of this function. Therefore, the claims lack adequate written description.
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 1-8 are rejected under 35 USC § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor, or a joint inventor, regards as the invention.
With respect to claim 1 and dependents thereof, there is uncertainty regarding the metes and bounds of the claimed system. The claimed system comprises a number of modules configured to perform various functions, wherein the modules “are software modules stored in one or more memories and executable by one or more processors coupled to the one or more memories” (lines 9-11). Although referenced therein, memories and processors are not listed as elements of the claimed system per se.
It is unclear whether memories or processors are intended to be components of the claimed system, or external elements that interface with the claimed system. Thus, the scope of the claim is indefinite. For purposes of applying prior art, the recited one or more memories and one or more processors are interpreted as components of the claimed system.
With respect to claim 6, there is uncertainty regarding scope of recited limitations concerning the psoriasis area and severity index (PASI). The claim requires that the data analysis module is configured “to use a psoriasis area and severity index (PASI) method for evaluation” (lines 4-5). The claim also recites the terms “PASI-1” (lines 9-10) and “PASI-2” (lines 14-15) in reference to recited mathematical relationships that define correlations between dsDNA serum content metrics and predicted ratings of psoriasis severity according to PASI.
The Psoriasis Area and Severity Index (PASI) is a conventional standard employed for classification of psoriasis based on severity of particular skin symptoms. The claimed invention does not directly assess severity of subject symptoms, but rather measures and analyzes dsDNA content of subject serum.
Thus, although the claims require that the data analysis module is concretely configured “to use a psoriasis area and severity index (PASI) method”, the named clinical standard is not directly employed. The PASI standard is well-known in the field of the invention. The apparent requirement of the claimed system “to use a [PASI] method”, in the course of molecular data analysis, may confuse a person of ordinary skill in the art.
Thus, the claim is indefinite. The Examiner suggests clarifying amendments, for example:
amendment of “configured to use a psoriasis area and severity index (PASI) method for evaluation” (lines 4-5) to “configured to predict a psoriasis area and severity index (PASI) value”;
amendment of “the PASI method is” (line 6) to “wherein the prediction method is”;
amendment of “moderate by PASI-1 increases… severe by PASI-1 increases… and” (lines 9-11) to “moderate by the method (PASI-1) increases… severe by PASI-1 increases… or”;
amendment of “moderate by PASI-2 increases” (line 14) to “moderate by the method (PASI-2) increases”.
For purposes of applying prior art, the limitations are interpreted in accordance with the Examiner’s suggestions.
With respect to claim 7, there is uncertainty regarding scope of recited limitations concerning the Body Surface Area (BSA) method. The claim requires that the data analysis module is configured “to use a body surface area (BSA) method for evaluation” (line 4). The claim also recites the terms “BSA-1” (lines 9-10) and “BSA-2” (lines 14-15) in reference to mathematical relationships that define correlations between dsDNA serum content metrics and predicted ratings of psoriasis severity according to BSA.
Body Surface Area (BSA) is a conventional standard employed for classification of psoriasis based on amount of affected skin as a percentage of total subject surface area. The claimed invention does not directly assess affected surface area of subjects, but rather measures and analyzes dsDNA content of subject serum.
Although the claims require that the data analysis module is concretely configured “to use a Body Surface Area (BSA) method”, the named clinical standard is not directly employed. The BSA standard is well-known in the field of the invention. The apparent requirement of the claimed system “to use a [BSA] method”, in the course of molecular data analysis, may confuse a person of ordinary skill in the art.
Thus, the claim is indefinite. The Examiner suggests clarifying amendments, for example:
amendment of “configured to use a body surface area (BSA) method for evaluation” (line 4) to “configured to predict a body surface area (BSA) value”;
amendment of “wherein the BSA method is” (line 6) to “wherein the prediction method is”;
amendment of “moderate by BSA-1 increases… severe by BSA-1 increases… and” (lines 9-11) to “moderate by the method (BSA-1) increases… severe by BSA-1 increases… or”;
amendment of “moderate by BSA-2 increases” (line 14) to “moderate by the method (BSA-2) increases”.
For purposes of applying prior art, the limitations are interpreted in accordance with the Examiner’s suggestions.
With respect to claim 8, there is uncertainty regarding scope of the recited limitation of “whether there is a history of psoriasis” (line 3). For purposes of prior art, the limitation is interpreted as “whether there is a history of psoriasis associated with the corresponding subject”.
For the above reasons, the claims are indefinite.
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 1-8 are rejected under 35 USC § 101 because the claimed invention is directed to non-statutory subject matter.
"Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I).
Abstract ideas include mathematical concepts (including formulas, equations and calculations), and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
Natural phenomena and laws of nature and include principles, relations, and products that are naturally occurring or do not have markedly different characteristics compared to what occurs in nature (MPEP 2106.04(b)).
The claims as a whole, considering all claim elements both individually and in combination, are not directed to statutory subject matter (see Step 1). Additionally, under interpretation of the claims as being directed to statutory subject matter for the purpose of further analysis, the claims do not amount to significantly more than abstract ideas and natural phenomena (see Steps 2A-B).
Step 1: The Four Categories of Statutory Subject Matter (MPEP 2106.03)
The claims are directed to a system comprising software modules. Although the claims indicate that these modules are stored in “one or more memories” and executable by “one or more processors”, it is not clear that any “memories” or “processors” are part of the claimed system itself. In other words, the system as claimed amounts to software per se. The courts have held that “For all categories except process claims, the eligible subject matter must exist in some physical or tangible form” (Digitech Image Techs. V. Electronics for Imaging, 758 F.3d 1344, 1348 (Fed. Cir. 2014). Hence, the claims are not directed to statutory subject matter. See MPEP 2106.03 § I.
The Examiner suggests amendment to clearly recite “one or more memories” and/or “one or more processors” as components of the claimed system and indicate that the modules are stored on, and/or executable by, these constituent components. Recitation of hardware components would cause the claimed system to fall under the ‘machine’ category of statutory subject matter, and thus overcome this portion of the rejection..
However, such amendment alone would likely not overcome rejection for recitation of judicial exceptions without significantly more. In the interest of compact prosecution, the referenced “one or more memories” and “one or more processors” have been interpreted as components of the claimed system for further analysis below regarding recitation of judicial exceptions without significantly more.
Step 2A, Prong One: Whether the Claims Set Forth or Describe a Judicial Exception (MPEP 2106.04 § II.A.1)
‘Mathematical concepts’ are relationships between variables and numbers, numerical formulas or equations, or acts of calculation, which need not be expressed in mathematical symbols (MPEP 2106.04(a)(2) § I). The claims recite elements which encompass mathematical relationships, including:
“for every one standard deviation increase in the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point, a risk increases by 1.84 times which is corresponding to an odds ratio (OR) value of 2.84 and a 95% confidence interval (CI) of 2.01-4.01” (claim 3);
“for every 0.12 ng/ml increase in a difference between the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point… an odds ratio (OR) value of the risk of occurrence of psoriasis is 4.88 and a 95% CI is 3.85-6.20” (claim 4);
“for every 0.34 ng/ml increase in a difference between the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point… an OR value of the risk of occurrence of psoriasis is 1.97 and a 95% CI is 1.74-2.22” (claim 4);
“for every 1 ng/ml increase in the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point, the risk of being rated as moderate by PASI-1 increases by 0.66 times which is corresponding to an OR value of 1.66 and a 95% CI of 1.10-2.50 and the risk of being rated as severe by PASI-1 increases by 1.43 times which is corresponding to an OR value of 2.43 and a 95% CI of 1.77-3.35” (claim 6);
“for every 1 ng/ml increase in the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point, the risk of being rated as moderate by PASI-2 increases by 0.78 times which is corresponding to an OR value of 1.78 and a 95% CI of 1.29-2.46 and the risk of being rated as severe by PASI-2 increases by 1.38 times which is corresponding to an OR value of 2.38 and a 95% CI of 1.59-3.57” (claim 6);
“for every 1 ng/ml increase in the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point, the risk of being rated as moderate by BSA-1 increases by 0.83 times which is corresponding to an OR value of 1.83 and a 95% CI of 1.12-2.97 and the risk of being rated as severe by BSA-1 increases by 1.87 times which is corresponding to an OR value of 2.87 and a 95% CI of 1.90-4.33” (claim 7);
“for every 1 ng/ml increase in the dsDNA content at a succeeding time point from the dsDNA content at a preceding time point, the risk of being rated as moderate by BSA-2 increases by 0.66 times which is corresponding to an OR value of 1.66 and a 95% CI of 1.13-2.45 and the risk of being rated as severe by BSA-2 increases by 1.61 times which is corresponding to an OR value of 2.61 and a 95% CI of 1.84-3.72” (claim 7);
The recited mathematical relationships constitute mathematical concepts.
‘Mental processes’ are processes that can be performed in the human mind at least with use of a physical aid, e.g., a slide rule or pen and paper (MPEP 2106.04(a)(2) § III). The claims recite elements that encompass processes that are practicably performable in the human mind, at least under their broadest reasonable interpretation, including:
“evaluat[ing] psoriasis based on the dsDNA content” (claim 1), i.e., making a clinical conclusion based on a related value;
“us[ing] a psoriasis area and severity index (PASI) method for evaluation” (claim 6), i.e., making a clinical conclusion using a certain type of scoring method;
“us[ing] a body surface area (BSA) method for evaluation” (claim 7) i.e., making a clinical conclusion using a certain type of scoring method; and
“record[ing] the dsDNA content of the serum sample to be detected at different time points and whether there is a history of psoriasis” (claim 8), i.e., recording information.
The recited steps of evaluating information, which are practicably performable in the human mind, constitute mental processes.
Mathematical concepts and mental processes constitute enumerate d categories of abstract ideas (MPEP 2106.04(d)(2) §§ I and III). Hence, the claims recite elements that, individually and in combination, constitute an abstract idea.
The mathematical relationships cited above define correlations between serum parameters and disease severity, and so additionally constitute laws of nature. Furthermore, the claims indicate that:
“the serum sample to be detected is a serum sample without phenotype” (claims 1-4) , i.e., a sample of serum from a subject who has not exhibited clinical symptoms of psoriasis on their skin;
measured dsDNA content can be
“greater than or equal to 1.11 [ng/ml]” (claims 1 and 4-5),
“greater than or equal to 0.97 ng/ml and less than 1.11 ng/ml” (claim 2),
“greater than or equal to 0.86 ng/ml and less than 0.97 ng/ml” (claim 2),
“less than 0.86 ng/ml” (claim 2), and
“less than 1.11 ng/ml” (claim 4);
particular recited ranges of dsDNA content indicate the following clinical results:
“abnormal and extremely high risk” (claim 1),
“normal and high risk” (claim 2),
“normal” (claim 2),
“suspicious of other diseases” (claim 2),
“whether the dsDNA content is normal and a corresponding risk factor” (claim 3),
“whether the dsDNA content is normal and the corresponding OR value” (claim 4),
“very likely to relapse” (claim 5),
psoriasis severity as assessed by a psoriasis area and severity index (PASI) method (claim 6), and
psoriasis severity as assessed by a body surface index (BSA) method (claim 7).
“the serum sample to be detected is a phenotyped and cured serum sample” (claim 5), i.e., a sample of serum from a subject who has exhibited clinical symptoms of psoriasis on their skin and has been cured; and
“the serum sample to be detected is a phenotyped serum sample” (claims 6-7) i.e. a sample of serum from a subject who has exhibited clinical symptoms of psoriasis.
The above elements indicate naturally occurring phenomena, and naturally occurring relationships that the claimed invention allows a user of the claimed device or method to observe. Hence, the claims recite elements that constitute a natural phenomenon.
The claims must therefore be examined further to determine whether they integrate these judicial exceptions into a practical application (MPEP 2106.04(d)).
Step 2A, Prong Two: Whether the Claims Contain Additional Elements that Integrate the Judicial Exception(s) into a Practical Application (MPEP 2106.04 § II.A.2)
The claims recite additional elements that gather data necessary for performance of claimed functions or output results of claimed functions, including:
“acquir[ing] a double-stranded deoxyribonucleic acid (dsDNA) content of a serum sample to be detected” (claim 1), including:
“acquir[ing] the dsDNA content twice or more at different time points” (claims 3 and 6-7); and
“output[ting] one of results according to the evaluated psoriasis” (claim 1).
Necessary data gathering and output are considered to be insignificant pre-solution activities, and as such insufficient to integrate an abstract idea into a practical application (MPEP 2106.05(g)).
The claims further recite additional elements that constitute computer hardware for storing and executing software implementations of recited functions, including:
“one or more memories” (claim 1); and
“one or more processors” (claim 1).
The claims do not describe any specific computational steps by which computer hardware performs or carries out functions drawn to the judicial exceptions, nor do they provide any details of how specific structures of a computer are used to implement these functions. The claims state nothing more than that the above computer hardware elements store and execute software implementations of judicial exceptions, and therefore amount to mere instructions to apply the judicial exceptions using computer hardware. As such, the claims do not integrate the judicial exceptions into a practical application (see MPEP 2106.04(d) § I and 2106.05(f)).
No further additional elements are recited.
When the claims are considered as a whole: they do not improve the functioning of a computer, other technology, or technical field (MPEP 2106.04(d)(1) and 2106.05(a)); they do not apply the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)); they do not implement the judicial exceptions with, or in conjunction with, a particular machine (MPEP 2106.05(b)); they do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)); and they do not apply or use the judicial exceptions in some other meaningful way beyond linking the use of the judicial exceptions to a particular technological environment and/or field of use (e.g., evaluation of psoriasis; MPEP 2106.05(e) and 2106.05(h)).
Therefore, the claims do not integrate the recited judicial exceptions into a practical application. See MPEP 2106.04(d) § I.
Because the claims recite an abstract idea and a natural phenomenon, and do not integrate those judicial exceptions into a practical application, the claims are directed to those judicial exceptions. Claims that are directed to judicial exceptions must be examined further to determine whether the additional elements besides the judicial exceptions render the claims significantly more than the judicial exceptions. Additional elements besides the judicial exceptions may constitute inventive concepts that are sufficient to render the claims significantly more (MPEP 2106.05).
Step 2B: Whether the Claims Contain Additional Elements that Amount to an Inventive Concept (MPEP 2106.05)
As noted above, several recited additional elements amount to insignificant extra-solution activity. Mere addition of insignificant extra-solution activity does not amount to an inventive concept that would render the claims significantly more than the recited judicial exceptions, particularly when the activities are well-understood or conventional (MPEP 2106.05(g)). The conventionality of recited additional elements that amount to insignificant extra-solution activity must be further considered.
Recited additional elements amounting to insignificant extra-solution activity include the following process, which is indicated as activity that may be performed with commercially-available products by the instant specification (see MPEP 2106.07(a) § III):
acquiring a double-stranded deoxyribonucleic acid (dsDNA) content of a serum sample to be detected (para. 0021).
Additionally, recited additional elements amounting to insignificant extra-solution activity encompass the following computer-implemented functions, which the courts have held as coextensive with a general-purpose computer and/or well-understood, routine and conventional:
Displaying the result of data analysis (TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 612-13 (Fed. Cir. 2016)); and
Displaying electronic data (Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45 (Fed. Cir. 2018)).
Hence, the encompassed extra-solution activity is considered well-understood, routine and conventional. Well-understood, routine and conventional activity is insufficient to constitute an inventive concept that would render the claims significantly more than judicial exceptions (MPEP 2106.05(d)).
Mere instructions to implement judicial exceptions using a computer are, when considered individually, similarly insufficient to constitute an inventive concept that would render the claims significantly more than said judicial exceptions (see MPEP 2106.05(f)).
When the claims are considered as a whole, they do not integrate the judicial exceptions into a practical application; they do not confine the use of the judicial exceptions 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 judicial exceptions to a particular technological environment and/or field of use (e.g., evaluation of psoriasis). See MPEP 2106.05(h).
Therefore, the claims do not include additional elements sufficient to provide an inventive concept and/or amount to significantly more than the recited judicial exceptions. See MPEP 2106.05.
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole, are directed to judicial exceptions and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the judicial exceptions, so the claims are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Conclusion
At this point in prosecution, no claim is allowed.
The following prior art, made of record and not relied upon, is considered pertinent to applicant's disclosure:
Anani et al (Psoriasis: Targets and Therapy 10: 13-21; published 5/21/2020) presents a study of correlation between serum concentrations of circulating cell-free DNA and psoriasis severity as defined by PASI, and suggests its employment as a biomarker to monitor psoriasis severity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore C. Striegel whose telephone number is (571)272-1860. The examiner can normally be reached Mon-Fri 12pm-8pm ET.
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/T.C.S./Examiner, Art Unit 1685
/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 April 18, 2026
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