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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/17/2025 has been entered.
Response to Amendment
The amendment filed 11/10/2025 in which claims 1, 9-11 were amended, and claims 20 was canceled, new claims 22-24 were added, has been entered. Claims 7, 8, 11, 14-16, 18, and 21 were previously withdrawn. Claims 2-6, 12, 13, and 15 were previously canceled.
Amended claim 1 recites SEQ ID NO: 32 and SEQ ID NO: 9 which are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: as indicated in the Restriction Action issued 10/24/2024, the species are independent or distinct because: (SEQ ID NO:) sequences encoding different proteins are structurally distinct chemical compounds and are unrelated to one another. These sequences are thus deemed to constitute independent and distinct inventions within the meaning of 35 U.S.C. § 121. Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement pursuant to 35 U.S.C. § 121 and 37 CFR 1.141 et seq. (MPEP § 803.04).
Applicant elected the peptide pair of SEQ ID NO: 32 and SEQ ID NO: 83; in the reply filed on 12/12/2024.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, SEQ ID NO: 9 on claim 1 is withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and MPEP § 821.03. The present Office Action is constructed to address the originally presented invention comprising the peptide pair of SEQ ID NO: 32 and SEQ ID NO: 83.
Similarly, amended claim 9 recites SEQ ID NO: 3 and SEQ ID NO: 26 which are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: as indicated in the Restriction Action issued 10/24/2024, the species are independent or distinct because: (SEQ ID NO:) sequences encoding different proteins are structurally distinct chemical compounds and are unrelated to one another. These sequences are thus deemed to constitute independent and distinct inventions within the meaning of 35 U.S.C. § 121. Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement pursuant to 35 U.S.C. § 121 and 37 CFR 1.141 et seq. (MPEP § 803.04).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 9 is withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 1, 10, 17, 22-24 are under examination on the merits.
Claim Objections
(New objection, as to new claim 22). Claim 22 is objected to because of the following informalities:
On claim 22, the recitation of “determining whether a sample of the subject reacts with a peptide P,” bears a grammatical mistake because the conjunction ‘whether’ is used to introduce a choice between two or more options. The above recitation should read “determining whether a sample of the subject reacts with a peptide P or not.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
(Previous rejection withdrawn as to claims 1, 10, 17 and 20) Claims 1, 10, 17 and 20 were 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.
See claims 1, 10, 17, 20 as submitted on 11/10/2025.
The previous rejection of claim 20 is moot in view of Applicant’s cancelation of this claim.
Applicant’s amendments to the instant claims filed on 11/10/2025 have overcome the previous rejection to claims 1, 10, 17.
(New rejection necessitated by amendment as to claims 1, 10, 17 and 22-24) Claims 1, 10, 17 and 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 1, 10, 17, 22-24 as submitted on 11/10/2025.
Claims 1 and 23 recite the term “corresponding peptide C”, it is not clear what this term refers to or how the term is to be understood. Specifically, it is not clear which peptides are encompassed by this term. The scope of the claimed invention is indefinite where the meets and bounds of the term were not defined. The Specification at page 19 refers to sequence homology between peptides P and C, however it is not defined what is considered ‘homologous’ in reference to these two peptides. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claims 1 was herein interpreted as referring to a peptide P and a peptide C.
Further amended claim 1 recites “the peptide” on multiple instances and it is unclear which peptide is being referred to. Specifically, it is unclear if “the peptide” at the beginning of line 9 refers to the P or the C peptide or a different peptide. Further, “it is unclear if “the peptide” at the beginning of lines 13 and 16 refers to the P or the C peptide or a different peptide. For the purposes of compact prosecution and applying prior art, the instances where claims 1 recites “the peptide” were herein interpreted as referring to “a peptide”.
Claim 1 recites "the ZIKV-specific peptide" and "the DENV-specific peptide" on lines 11 and 14, respectively. There is insufficient antecedent basis for these recitations in the claim because there is no previous mention of such peptides in the claim. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claims 1 was herein interpreted as referring to "a ZIKV-specific peptide" and "a DENV-specific peptide" on lines 11 and 14, respectively.
Amended claim 1 recites “the DENV-specific peptide of SEQ ID NO: 9…” This recitation is unclear because it is inconsistent with the Specification (page 8) which lists the sequence of SEQ ID NO: 9 as a ZIKV-specific peptide. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claims 1 was herein interpreted as referring to a DENV-specific peptide.
Claim 1 recites “a relative binding capacity” and claim 22 recites “a relative binding capacity BCrelative ≤0.05 or ≥ 0.1”. It is unclear what is meant by these recitations, the terms are not adequately defined in the Specification and a standard for ascertaining the requisite degree is not provided. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, the relative binding capacity is recited to be ≤ 0.05 or ≥ 0.1, however the Specification refers to values ≥ 0.05 and ≤ 0.1 (Table 3). The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claims 1 and 22 were herein interpreted as referring to a binding read out.
On claims 22 and 23 the recitation of “ZIKV-derived peptide” and “DENV-derived peptide” are not clear because it is not indicated what the term “derived” means. The Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claims are indefinite. For purposes of compact prosecution and applying prior art, claims 22 and 23 were interpreted herein as referring to a ZIKV peptide and a DENV peptide.
Claim 22 recites the functional limitation “capable of giving a relative binding capacity BCrelative ≤0.05 or ≥ 0.1”. It is unclear what is meant by this recitation because as indicated above the term “relative binding capacity” is not defined in instant application. The specification appears to indicate that a “relative binding capacity” is used to assess the specificity of an epitope of a given antibody to a flavivirus (page 18). However, it is not clear what is encompassed by the term “capable of giving a relative binding capacity BCrelative ≤0.05 or ≥ 0.1” The dependent claims do not add additional clarity and, therefore, are also indefinite.
On claims 22 and 23 the terms “reacts with a peptide P” (claim 22, line 2), “reacts with the peptide that is capable of giving..” (claim 22, lines 25, 28), “having a sequence homologous” (claim 22, lines 8, 11, 16, 19), “a common flavivirus peptide” (claim 22, line 23) and “binding activity” (claim 23, lines 1, 2, et.) are vague and do not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For instance, it is unclear what is encompassed by the term “reacts” or having sequence homology, or “common flavivirus peptide”, etc. Therefore, the claims are indefinite. The Specification does not provide a standard for ascertaining the requisite degree for these terms, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claims are indefinite.
Claim 24 recites “the subject indicated with ZIKV and/or DENV infection.” It is unclear what is meant by this recitation because it could refer to a subject diagnosed with ZIKV infection or a subject suspected to have a ZIKV infection, or a subject at risk of ZIKV infection, etc. The Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claim is indefinite.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
Claim Rejections - 35 USC § 112(a) - Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
(Previous rejection, withdrawn as to claims 1, 10, 17, 20) Claims 1, 10, 17, and 20 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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 the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 1, 10, 17, 20 as submitted on 11/10/2025.
The previous rejection of claim 20 is moot in view of Applicant’s cancelation of this claim.
Applicant’s amendments to the instant claims filed on 11/10/2025 have overcome previous rejection to claims 1, 10, 17.
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.
(Previous rejection, withdrawn as to claim 20; maintained and modified as necessitated by amendment as to claims 1, 10, 17; expanded as to new claims 22-24) Claims 1, 10, 17, 20, 22-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 1, 10, 17, 20, 22-24 as submitted on 11/10/2025.
The previous rejection of claim 20 is moot in view of Applicant’s cancelation of this claim.
Regarding amended claims 1, 10, 17 and new claims 22-24, these claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ).
The claims are directed to a process, which is one of the four statutory categories of invention (Step 1: YES).
The amended claims are directed to the natural correlation between the binding of antigen binding proteins to a peptide P and a peptide C in a sample, as recited in claim 1. The instant claims are further directed to the mental step of appreciating the natural correlation to determine or assess if the subject to whom the sample belongs has a flavivirus infection, and further to the mental step of appreciating the natural correlation to distinguish between flavivirus infections and between two specific flavivirus infections, ZIKV infection or DENV infection. As such, the instant claims recite judicial exceptions (JEs) in the form of a law of nature and abstract idea (Step 2A, Prong One: YES).
Specifically, the amended claims are drawn, inherently or explicitly, to a method for identifying a flavivirus infection selected from Zika virus (ZIKV) or dengue virus (DENV) in a subject, the method comprising the following steps:
a) contacting a peptide P and a peptide C with an antigen binding protein,
b) detecting binding thereby obtaining a read out, determining a relative binding capacity wherein the step of determining comprises determining if the relative binding capacity is ≥ 0.1,
c) distinguishing a ZIKV infection from a DENV infection by
d) determining if the sample reacts with the peptides in SEQ ID NOs: 32, 9.
The crux of the claimed method is the appreciation of the natural correlation between the binding of antigen binding proteins to a peptide P and a peptide C in a sample. It is noted that the recitation in amended claim 1 of “the method further distinguishes” refer to the mental steps of appreciating the natural correlation between the binding of antigen binding proteins to a peptide P and a peptide C in a sample. The method itself does not distinguish nor determines. The steps of distinguishing and determining can be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Contacting and detecting the natural correlation in a biological sample would constitute insignificant extra-solution activities.
It is noted that the claims further require determining a “relative binding capacity.” This not a particular field of use, but, rather, a generic way to obtain a read out from the natural correlation in a biological sample. Hence, claim 1 does not recite additional elements that integrate the judicial exception (abstract idea) into a practical application. Integration into a practical application requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html). Further, the steps of “distinguishing” and “determining” in claim 1 are performed separately from the step of obtaining the read out. There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). Further, generally linking of the use of the judicial exception to a particular technological environment or field of use is not indicative of integration into a practical application – see MPEP 2106.05(h)”. Specifically regarding claim 24 and the recitation of “treating the subject indicated with ZIKV and/or DENV infection with an anti-inflammatory agent”, the claim as a whole is not limited to a particular treatment or prophylaxis because the recitation indicated above constitutes a generic instruction to treat. Further, generally linking of the use of the judicial exception to a particular technological environment or field of use is not indicative of integration into a practical application.
As such, the instant claims do not recite additional elements that integrate the JEs into a practical application (Step 2A, Prone Two: NO).
As discussed previously, it was well-understood, routine, and conventional (WURC) at the time of filing to perform an immunoassay. As such, beyond the JEs, the instant claims only recite WURC data-gathering steps and generic instructions to apply the JE. These constitute insignificant extra-solution activities, which do not reasonably provide an inventive concept.
As such, the instant claims do not recite significantly more than the JE (Step 2B: NO).
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C § 101.
Response to Arguments
Applicant's arguments filed 10/11/2025 have been fully considered but they are not persuasive.
Applicant contends on page 15 of the Remarks submitted on 10/11/2025:
“The amended method includes a practical application of identifying subjects with ZIKV and/or DENV infection by determining whether a sample of the subject reacts with the ZIKV- specific peptide of SEQ ID NO: 32 and/or the DENV-specific peptide of SEQ ID NO: 9 or not, When the sample reacts with ZIKV-specific peptide of SEQ ID NO: 32, the subject with ZIKV infection is identified and when the sample reacts with DENV-specific peptide of SEQ ID NO: 9, the subject with DENV-infection is identified. In view of the above, amended claim 1 clearly includes elements that can be integrated into a practical application and does not include a judicial exception solely.
In response:
As indicated above and previously, the crux of the claimed method is the appreciation of the natural correlation between the binding of antigen binding proteins to a peptide P and a peptide C in a sample. It is noted that the recitation in amended claim 1 of “the method further distinguishes” refer to the mental steps of appreciating the natural correlation between the binding of antigen binding proteins to a peptide P and a peptide C in a sample. The method itself does not distinguish nor determines. These steps of distinguishing and determining can be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Contacting and detecting the natural correlation in a biological sample by performing an immunoassay would constitute insignificant extra-solution activities. Further, the recitation of “identifying a flavivirus infection selected from Zika virus (ZIKV), or dengue virus (DENV)” does not constitute a practical application in the claim but rather it states the aim of the claimed method.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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