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 .
Herein, “the previous Office action” refers to the Non-Final Rejection filed 4/22/2026.
Amendments Received
Amendments to the claims were received on 6/18/2026.
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’s provision of an English translation of the listed foreign priority document (CN 202111239725.2; filed 10/25/20121)is acknowledged.
Withdrawn Objections/Rejections
The objection to the drawings is hereby withdrawn in view of Applicant’s submission of Replacement Sheets bearing additional labels to further clarify represented information.
The objection to the specification is hereby withdrawn in view of Applicant’s amendment of the specification to correct the abstract (in accordance with MPEP § 608.01(b)) and correct improper usage of trade names and marks.
The objection to claim 4 is hereby withdrawn in view of Applicant’s amendment of the claim to correct a minor typographic error.
The rejection of claims 1-8 under 35 USC § 112(b), as being indefinite, is hereby withdrawn in view of Applicant’s amendment of the claims to clarify indefinite language (see Remarks filed 6/18/2026 at pg. 12, paras. 3-5).
Claim Status
Claims 1-8 are pending, and under examination.
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”.
Response to Arguments - Claim Rejections Under 35 USC § 112
In the Remarks filed 6/18/2026, Applicant traverses the rejection under 35 USC § 112(a) and presents supporting arguments.
Applicant notes amendment of claim 1 to explicitly define the data acquisition module as performing the quantitative dsDNA detection method, points to description of said method in the specification (at para. 0021), and alleges that one of ordinary skill in the art can readily implement the described detection steps as automated processes controlled by the processor (Remarks at pg. 11, para. 7 – pg. 12, para. 2).
The recited detection steps, by Applicant’s own admission in the Remarks (at pg. 11, para. 7), involve specialized hardware components (e.g., a centrifuge) beyond the recited one or more processors and one or more memories. It is unclear how one of ordinary skill in the art could implement these detection steps, via a processor, in the absence of all necessary specialized hardware components.
For the above reasons, the arguments are found unpersuasive and the rejection under 35 USC 112(a) is maintained.
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 claims 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. This rejection is maintained from the previous Office action and has been revised for additional clarity.
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 by performing… serum collection, staining with a dsDNA staining solution” (lines 2-5). This is a functional limitation of the “data acquisition module”, a processor-executable software module.
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 using the recited hardware. Para. 0013 of the specification also indicates that the DNA “content” is measured in units of ng/ml, and thereby indicates that the measurement is physical rather than mere gathering of information content (i.e., data).
It is unclear how the claimed system accomplishes this physical function, given that the specification describes the accomplishment of said function using components (e.g., a vacuum coagulation-promoting tube) that are not recited by the claims and furthermore does not describe how these components would be employed by the claimed system. Therefore, the claims lack adequate written description.
Response to Arguments - Claim Rejections Under 35 USC § 101
In the Remarks filed 6/18/2026, Applicant traverses the rejection under 35 USC § 101 and presents supporting arguments.
Applicant notes that claim 1 recites tangible, physical hardware components (e.g., one or more processors) as integral, mandatory elements of the claimed evaluation system, and that the system performs a physical method (pg. 12, para. 9 – pg. 13, para. 3).
The tangibility of recited subject matter does not necessarily demonstrate its patent eligibility under section 101. As noted by the Court in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224 (2014), “[t]he fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point. There is no dispute that a computer is a tangible system… But if that were the end of the § 101 inquiry, an applicant could claim any principle of the physical or social sciences by reciting a computer system configured to implement the relevant concept… thereby eviscerating the rule that ‘[l]aws of nature, natural phenomena, and abstract ideas are not patentable” (573 U.S. at 224). The claims recite elements that encompass abstract ideas and naturally-occurring phenomena, and the tangibility of the system does not, by itself, integrate these judicial exceptions into a practical application or provide an inventive concept sufficient to render the claims as significantly more. Thus, the argument is found unpersuasive.
Applicant alleges that the system provides concrete medical-diagnostic functions with real-world benefits (pg. 13, para. 3). The prospective usefulness of an invention within a particular field is not equivalent to integration into a practical application. The claimed invention does not, for example, administer a particular treatment to a patient based on the recited analysis. The patent eligibility of the claims under § 101 concerns any integration and/or inventive concepts provided by recited additional elements, not speculative applications or utility. Thus, the argument is found unpersuasive.
Applicant alleges that the recited dsDNA quantification protocol is not well-understood, routine and conventional (pg. 13, para. 4). The recited dsDNA quantification process is data-gathering activity, which is performed to acquire input data necessary for the performance of further analysis steps. The specification indicates that said process can be performed with commercially-available products, e.g., a BioVision EZQuant™ dsDNA detection kit (see specification at paras. 0021 and 0057). As claimed, said process is considered insignificant extra-solution activity (see MPEP 2106.05(g)). Thus, the argument is found unpersuasive.
For the above reasons, the arguments are found unpersuasive and the rejection is maintained.
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. This rejection is maintained from the previous Office action, and has been revised to address the amended claims.
"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 which falls under the ‘machine’ category of statutory subject matter.
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 processors” (claim 1); and
“one or more memories coupled to the 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 September 18, 2026
