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 .
Status of the Claims
Claims 1-12 are pending and examined herein.
No claims are canceled.
Priority
As detailed on the 04 January 2024 filing receipt, the application claims priority as early as 18 October 2022 to foreign application JP 2022-167238. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Information Disclosure Statement
Information disclosure statement (IDS) was filed on 10 January 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the references are being considered by the examiner.
Drawings
The drawings are objected to because the text is blurry and unclear, particularly Fig, 5-8 where the captions and/or legends are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are the input unit, analytical measurement unit, memory unit, data processing unit, and output unit of claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The input unit is disclosed as including a keyboard or mouse for the purpose of inputting data (paragraph [69]).
The analytical measurement unit is disclosed as performed by a CPU (paragraph [71]).
The memory unit for storing data is disclosed as RAM, ROM, flash memory like fixed drives and optical drives (paragraph [68]).
The data processing unit is disclosed as performed by a CPU (paragraph [71]).
The output unit is disclosed as a display or printer (paragraph [72]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 3 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-12 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements individually and in combination, are directed to a judicial exception at Step 2A, Prong 2, and the additional elements of the claims, considered individually and in combination, do not provide significantly more at Step 2B than the abstract idea of providing information about a detected virus.
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of
nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The claims are directed to a method (claims 1-11) and a computer system (claim 12), each of which falls within one of the categories of statutory subject matter. [Step 1: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Claim 1 recites making a determination based on an indicator, where making a determination based on the data is interpreted as data evaluation and thus a mental process.
Claim 2 recites the indicator is associated with a measurement value, a correction value, or correction formula. The indicator is considered to be data per se and thus abstract, and is associated with values or formulas, which are considered numerical and thus mathematical concepts.
Claim 3 recites correction of the indicator using a value or formula, where a numerical correction is considered a verbal description of a mathematical process.
Claim 4 recites a parameter of the correction formula, where the formula is a mathematical concept.
Claim 5 recites additional information regarding the indicator. The indicator is considered to be data per se and thus abstract.
Claim 6 recites additional information regarding the virus being detected. The virus detected is part of the data processing and data per se is abstract.
Claim 7 recites interpreting a trend, where interpreting a trend is data evaluation and a step practically performed by the human mind.
Claim 8 recites interpreting the indicator as decreasing, increasing, or oscillating with convergence as conveying a different viral state, which is data evaluation and a step practically performed by the human mind.
Claim 9 recites a comparison between the indicator and a criterion, which comparing data is a step practically performed by the human mind.
Claim 10 recites selecting information for display, where data selection is a step practically performed mentally.
Claim 11 recites data related to therapy for the viral infection, where data per se is abstract.
Thus, the claims recite abstract ideas and thus must be examined further to determine whether elements in addition to the abstract ideas integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Because the claims recite judicial exceptions, direction under Step 2A Prong Two provides that the claims must be examined further to determine whether they recite elements in addition to the abstract ideas which integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(III)).
Claim 1 recites providing information. Claim 12 recites a system comprising input including a keyboard and mouse, output such as a display or printer, memory, and a CPU, and thus is considered to be a general purpose computer. Claim 12 also recites inputting information, storing information, and outputting results.
The claims comprising computer components do not describe any specific computational steps by which the computer performs or carries out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than that a generic computer performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
The claim elements comprising inputting data and providing or outputting data are considered to be data gathering or outputting steps. These steps are insignificant extra-solution activities which do not integrate the abstract ideas into a practical application (MPEP 2106.05(g)). The claim element comprising storing reads are mere instructions to apply an exception using a computer, which does not integrate the abstract ideas into a practical application (MPEP 2106.05(f)).
Thus, the claims recite elements in addition to the abstract ideas which do not integrate the abstract ideas into a practical application, and must be examined further to determine whether elements in addition to the abstract ideas provide significantly more (MPEP 2106.05). [Step 2A Prong Two: Yes]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claim 1 recites providing information. Claim 12 recites a system comprising input including a keyboard and mouse, output such as a display or printer, memory, and a CPU, and thus is considered to be a general purpose computer. Claim 12 also recites inputting information, storing information, and outputting results.
The claims recite a computer, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions, which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
The courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93 (storing and retrieving information in memory), as discussed in MPEP 2106.05(d)(II)(i)).
Therefore, the recited additional elements, alone or in combination, do not appear to provide an inventive concept. [Step 2B: No]
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 an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as
being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102(a)(1)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-6, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Ezra (US 2009/0281042 A1; newly cited).
Claim 1 recites making a determination on the detection and/or stage classification of virus infection and/or virus infection disease in the subject using an indicator associated with a D-amino acid in the subject.
Claim 1 recites providing information about virus infection and/or virus infection disease in the subject based on the results of the determination.
Ezra teaches using peptides to detect viruses (abstract) including use of non-conventional amino acids such as D-alanine, D-proline, and D-serine (pg. 7, Table 2).
Ezra further teaches detection is diagnostic of a medical condition (paragraph [38]), and diagnosing refers to identifying disease presence, monitoring progression, and forecasting outcomes (paragraph [163]), all of which are information based on the test about the viral infection.
Claim 12 recites a system comprising an input unit, analytical measurement unit, a memory unit, a data processing unit, and output unit for performing the steps of claim 1, together considered to be a general purpose computer.
Ezra recites the steps of claim 1 but not a computer. However, when the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable (MPEP 2121) and a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments (MPEP 2123). Therefore, one of ordinary skill in the art would have known to perform the steps using a computer.
Claim 5 recites the D-amino acid is one or more D-amino acids selected from the group consisting of D-proline, D-serine, D-alanine, and D-asparagine.
Ezra teaches D-alanine, D-proline, and D-serine (pg. 7, Table 2).
Claim 6 recites the virus is a virus belonging to a family selected from Orthomyxoviridae, Coronaviridae, Paramyxoviridae, Rhabdoviridae, Arenaviridae, Bunyavirales, Filoviridae, Retroviridae, Togaviridae, Flaviviridae, Picornaviridae, Astroviridae, Caliciviridae, Reoviridae, Parvoviridae, Adenoviridae, Papillomaviridae, Polyomaviridae, Herpesviridae, Hepadnaviridae, and Poxviridae.
Ezra teaches detection of Orthomyxoviridae, Coronaviridae, Paramyxoviridae, Rhabdoviridae,, Bunyavirales, Filoviridae, Retroviridae, Togaviridae, Flaviviridae, Picornaviridae, Astroviridae, Caliciviridae, Reoviridae, Parvoviridae, Adenoviridae, Polyomaviridae, Herpesviridae, and Hepadnaviridae (paragraph [99]).
Claim 10 recites the information about virus infection and/or virus infection disease in a subject is information on an event selected from the group consisting of whether or not virus infection and/or virus infection disease in the subject is detected; stage classification of virus infection disease in the subject; validation of test results and/or diagnosis results on virus infection and/or virus infection disease in the subject; and selection of therapeutic means for virus infection disease in the subject.
Ezra teaches detecting references to identifying the presence of the virus (paragraph [162]), where detecting the virus reads on identifying its presence.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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 U.S.C. 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ezra as applied to claims 1, 5-6, 10, and 12 under 35 USC 102 above and further in view of Hesaka (Scientific Reports 9(5104): 8 pgs., 2019; previously cited on the 10 January 2024 IDS form).
Claim 2 recites the indicator associated with a D-amino acid is a measurement value for the D-amino acid in blood or its correction value or correction formula.
Hesaka teaches blood levels of D-serine (abstract).
Claim 3 recites the indicator associated with a D-amino acid is a value or formula obtained by correcting the amount of the D-amino acid by a parameter associated with a biological substance (e.g., an L-amino acid) in the subject.
Hesaka teaches relating D-amino acids to total amino acids (%D) (pg. 3, third paragraph).
Claim 4 recites the indicator associated with a D-amino acid is a value or formula obtained by correcting the amount of the D-amino acid by a parameter associated with a kidney function in the subject.
Hesaka teaches relating D-amino acid amount to total amino acid amount (%D) is related to chronic kidney disease (pg. 3, third paragraph).
Claim 9 recites the determination on the detection and/or stage classification of the virus infection and/or virus infection disease is carried out by comparing the indicator associated with a D-amino acid in the subject with a determination criterion for virus infection and/or virus infection disease.
Ezra teaches D-amino acids as virus indicators and Hesaka teaches comparison of D-amino acid levels differing in individuals with and without the disease state (Fig. 1a), where the criterion is interpreted as the significant difference between the groups.
Combining Ezra and Hesaka
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the work of the Ezra, which is directed to using non-conventional amino acids such as D-amino acids in virus detection and diagnosis, with the work of Hesaka because Hesaka teaches using D-amino acids as liquid biopsy detected biomarkers rather than performing cleavage experiments, with the advantages being using urine in particular can be used to detect D-amino acids not previously found in blood (pg. 3, third paragraph). Furthermore, plasma concentrations of D-amino acids are demonstrated by Hesaka to readily distinguish subjects with and without the disease state (Fig. 1). Ezra and Hesaka are both directed to the shared field of endeavor of typing disease conditions using biomolecular data and their combination is considered prima facie obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ezra as applied to claims 1, 5-6, 10, and 12 under 35 USC 102 above and further in view of Curiel (US 20220008276 A1; newly cited).
Claim 11 recites the therapeutic means for virus infection disease include means selected from antivirus drug, blood purification therapy, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO).
Curiel teaches treatment of viral infections, such as COVID-19, by antiviral drugs (paragraph [8]), mechanical ventilation (paragraph [25]), and ECMO (paragraph [25]).
Combining Ezra and Curiel
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the work of the Ezra, which is directed to using non-conventional amino acids such as D-amino acids in virus detection and diagnosis, with the work of Curiel because while Ezra teaches therapeutic agents and pharmaceutic compositions which interfere with the virus (Ezra: paragraphs [231-232]), Curiel teaches numerous more specific methods for treating viruses, particularly COVID-19 (Curiel: paragraph [25]). This would be prima facie obvious to combine with Ezra because Ezra specifically teaches application to Coronaviridae (paragraph [99]).
Subject Matter Free of the Prior Art
Claim 7 recites the determination on the detection of the virus infection and/or virus infection disease includes when the indicator associated with a D-amino acid in the subject has exhibited a decreasing trend, determining that the subject has become infected with virus and/or affected with virus infection disease. Claim 8 teaches additional interpretations of the disease state based on D-amino acid levels. While Hesaka teaches increased D-serine due to advancement of chronic kidney disease (pg. 5, fifth paragraph), a decrease in the D-amino acid amount indicating the disease condition is not taught or fairly suggested, and so claims 7-8 are considered free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert J Kallal whose telephone number is (571)272-6252. The examiner can normally be reached Monday through Friday 8 AM - 4 PM EST.
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/Robert J. Kallal/Examiner, Art Unit 1685
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