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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group I, claims 1, 7, 8, 12, 13, 19, 20, 22, and 23 filed January 21, 2026 is acknowledged and has been entered. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 24-28, 31, 32, and 34-38 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1, 7, 8, 12, 13, 19, 20, and 22-28, 31, 32, and 34-38 are pending. Claims 1, 7, 8, 12, 13, 19, 20, 22, and 23 are under examination.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Based on the Filing Receipt, the present application claims the benefit of priority of Provisional Application Number 63/311,510 filed on February 18, 2022 and Provisional Application Number 63/315,588 filed on March 2, 2022. Accordingly, the effective filing date of the instant application is February 18, 2022 which is the filing date of Provisional Application Number 63/311,510 from which the benefit of domestic priority is claimed.
Specification
3. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). In this case, the recitations of “a first threshold value” and “a second threshold value” lack clear antecedent basis in the specification. Paragraph [0052] in Applicant’s disclosure provides that “T1, T2, and T3 are various thresholds that are chosen by the user as part of the algorithm and are assessed based on the best performance metrics such as AUC, NPV, and PPV.” Paragraph [0137] also discusses thresholds without reference to a first value or a second value and also are deemed “chosen to optimize the negative predictive value of the resulting linear regression model.” Paragraph [0137] further shows that “Units for the IgE thresholds are KU/L” and that “The threshold for the logistic regression model for more than one epitope is unitless.” As such, it is deemed that the specification fails to provide proper antecedent basis to adequately define what is encompassed by the recitations of “first threshold value” and “second threshold value” in the claimed subject matter.
Claim Objections
4. Claim 1 is objected to in reciting ““a first threshold value” and “a second threshold value.” As set forth herein supra, the recitations of “a first threshold value” and “a second threshold value” are not provided with definitive values to clearly define the metes and bounds encompassed by the recitations. Paragraph [0052] in Applicant’s disclosure provides that “T1, T2, and T3 are various thresholds that are chosen by the user as part of the algorithm and are assessed based on the best performance metrics such as AUC, NPV, and PPV.” Paragraph [0137] also discusses thresholds without reference to a first value or a second value and are deemed “chosen to optimize the negative predictive value of the resulting linear regression model.” Paragraph [0137] only shows that “Units for the IgE thresholds are KU/L” and that “The threshold for the logistic regression model for more than one epitope is unitless.”
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.
5. Claims 1, 7, 8, 12, 13, 19, 20, 22, and 23 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.
Claim 1 is vague and indefinite in reciting “a first amount of a peanut protein” and “a second amount of a peanut protein” because it is unclear, as recited, which peanut protein in the method it refers to or intends. In particular, claim 1 lacks clear antecedent basis for the recitation of “peanut protein” since the claimed method recites “A method for determining a threshold cumulative reactive dose of a peanut peptide” in the preamble and “contacting a first peanut peptide” and “contacting a second peanut peptide” with a first and a second biological sample.
Claim 1 is indefinite in reciting “a first threshold value” and “a second threshold value” to provide a cumulative reactive dose because it is unclear, as recited, what is encompassed in these threshold values. In particular, “a first threshold value” and “a second threshold value” are subjective terms lacking a comparative basis for defining their metes and bounds.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. Claims 1, 7, 8, 12, 13, 19, 20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/428,273 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method for determining a threshold cumulative reactive dose (CRD) of a peanut peptide for a subject that provides determination of anaphylaxis risk in the subject which comprises: contacting at least one first peanut peptide coupled to a first solid support including microbead with at least one first biological sample obtained from the subject under conditions that permit binding of at least one allergy associated immunoglobulin (AAIg-1) which is either one of IgG or IgE in the first biological sample to the first peanut peptide to form an AAIg-1- first peptide complex bound to the first solid support, wherein the first peanut peptide comprises amino acid sequence WELQGDRRCQSQLER (SEQ ID NO: 1) or an amino acid sequence comprising SEQ ID NO: 1 having one to four conservative amino acid substitutions therein; contacting at least one second peanut peptide coupled to a second solid support including microbead with at least one second biological sample obtained from the subject under conditions that permit binding of at least one second allergy associated immunoglobulin (AAIg-2) which is either one of IgG or IgE in the second biological sample to the second peanut peptide to form an AAIg-2- second peptide complex bound to the second solid support, wherein the second peanut peptide comprises amino acid sequence EYDEDEYEYDEEDRR (SEQ ID NO:2) or an amino acid sequence comprising SEQ ID NO:2 having one to four conservative amino acid substitutions therein; contacting the at least one AAIg-1-first peptide complex with at least one AAIg-1-specific labeling reagent which is a first antibody conjugated to a first fluorophore under conditions that permit binding of the AAIg-1 specific labeling reagent to the AAIg-1-peptide complex, and contacting the at least one AAIg-2-peptide complex with at least one AAIg-2-specific labeling reagent which is a second antibody conjugated to a second fluorophore under conditions that permit binding of the AAIg-2 specific labeling reagent to the AAIg-2-peptide complex; measuring the binding of the at least one first fluorophore labeled AAIg-1-specific antibody to the at least one AAIg-1-peptide complex, thereby determining at least one AAIg-1-peptide binding value; and measuring the binding of the at least one second fluorophore labeled AAIg-2-specific antibody to the at least one AAIg-2-peptide complex, thereby determining at least one AAI-2-peptide binding value. When a) the at least one AAIg-1 binding value and the at least one AAIg-2 binding value are combined to generate a combined binding value (CBV) and the CBV is greater than a first threshold value, the subject has a cumulative reactive dose (CRD) of less than a first amount of a peanut protein, b) when the at least one AAIg-1 binding value and the at least one AAIg-2 binding value are combined to generate a CBV and the CBV is less than or equal to the first threshold value but greater than a second threshold value, the subject has a CRD of greater than or equal to about the first amount of a peanut protein to less than a second amount of a peanut protein; and c) when the at least one AAIg-1 binding value and the at least one AAIg-2 binding value are combined to generate a CBV and the CBV is less than or equal to a second threshold value, the subject has a CRD of greater than or equal to the second amount of a peanut protein; thereby providing risk of anaphylaxis in the subject. Measurement of the binding of the first fluorophore labeled AAIg-1-specific antibody to the at least one AAIg-1-peptide complex comprises measuring a first median fluorescent intensity (MFI-11), a MFI-12, and a MFI-13) of the first fluorophore. Measuring the binding of the second fluorophore labeled AAIg-2-specific antibody to the at least one AAIg-2-peptide complex comprises measuring a MFI-21, a MFI-22, and a MFI-23) of the second fluorophore.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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.
7. Claims 1, 7, 8, 12, 13, 19, 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Getts et al. (US 2019/226600) in view of Witmer et al. (Predicting eliciting dose at food challenge using epitope mapping in peanut allergic children. Allergy: European Journal of Allergy and Clinical Immunology, Vol. 74, Supp. Supplement 106, pp. 152. Abstract Number: PD0249. (August 2019)).
Getts et al. disclose a method for determining reactivity to peanuts (peanut allergy) and tolerance thereto of peanut peptides (biomarker peptides) for a subject. The method comprises contacting at least one first peanut peptide coupled to a first solid support with at least one first biological sample obtained from the subject under conditions that permit binding of at least one allergy associated immunoglobulin (AAIg-1) in the first biological sample to the at least one first peanut peptide to form an AAIg-1- first peptide complex bound to the first solid support, wherein the first peanut peptide comprises amino acid sequence WELQGDRRCQSQLER or an amino acid sequence comprising SEQ ID NO: 1 (SEQ ID NO: 39) having at least 15 amino acids; wherein the AAIg-1 is specifically immunoglobulin E (IgE) (IgE analyte), the SEQ ID NO: 1 (SEQ ID NO: 39) comprises an IgE reactive region (epitope Ara h 2.008), and the first solid support is a Luminex microsphere (Abstract; [0037, 0039, 0042, 0054, 0067, 0084, 0104, 0117]; Table 2; claim 18). Getts et al. also teach contacting at least one second peanut peptide coupled to a second solid support with at least one second biological sample obtained from the subject under conditions that permit binding of at least one second allergy associated immunoglobulin (AAIg-2) in the second biological sample to the at least one second peanut peptide to form an AAIg-2- second peptide complex bound to the second solid support, wherein the second peanut peptide comprises amino acid sequence EYDEDEYEYDEEDRR or SEQ ID NO: 2 (SEQ ID NO: 64), having at least 15 amino acids; wherein the AAIg-2 is specifically IgE (IgE analyte), and the SEQ ID NO: 2 (SEQ ID NO: 64) comprises an IgE reactive region (epitope Ara h 3.102), and the second solid support is a Luminex microsphere (Abstract; [0037, 0039, 0042, 0054, 0067, 0084, 0104, 0117]; Table 2). Getts et al. further teach contacting the at least one AAIg-1-first peptide complex with at least one AAIg-1-specific labeling reagent which is a first anti-human AAIg-1 antibody conjugated to a first fluorophore (fluorescent dye) under conditions that permit binding of the AAIg-1 specific labeling reagent to the AAIg-1-peptide complex, and contacting the at least one AAIg-2-peptide complex with at least one AAIg-2-specific labeling reagent which is a second anti-human AAIg-2 antibody conjugated to a second fluorophore under conditions that permit binding of the AAIg-2 specific labeling reagent to the AAIg-2-peptide complex [0054, 0056, 0065, 0084]; and measuring, by multiplex peptide-bead flow cytometric analysis, the binding of the at least one first fluorophore labeled AAIg-1-specific antibody to the at least one AAIg-1-peptide complex and the binding of the at least one second fluorophore labeled AAIg-2-specific antibody to the at least one AAIg-2-peptide complex, to thereby determine an at least one AAIg-1-peptide complex binding value and an at least one AAIg-2-peptide complex binding value [0058-0060]. The first peanut peptide is specifically SEQ ID No. 1 (SEQ ID No. 39) and the second peanut peptide is specifically SEQ ID No. 2 (SEQ ID No. 64) ([0117]; Table 2). The measurement of the first peanut peptide and the second peanut peptide may also be performed by a care point immunochromatographic device or lateral flow assay strip) [0061].
Getts et al. is silent in teaching that “when the at least one AAIg-1 binding value and the at least one AAIg-2 binding value are combined to generate a combined binding value (CBV) and the CBV is greater than a first threshold value, the subject has a cumulative reactive dose (CRD) of less than a first amount of a peanut protein; when the at least one AAIg-1 binding value and the at least one AAIg-2 binding value are combined to generate a CBV and the CBV is less than or equal to the first threshold value but greater than a second threshold value, the subject has a CRD of greater than or equal to about the first amount of a peanut protein to less than a second amount of a peanut protein; and when the at least one AAIg-1 binding value and the at least one AAIg-2 binding value are combined to generate a CBV and the CBV is less than or equal to a second threshold value, the subject has a CRD of greater than or equal to the second amount of a peanut protein.”
Witmer et al. performed studies to assess the ability and utility of bead-based epitope assay (BBEA) in predicting eliciting doses (Eds) in peanut allergic children who underwent double-blind, placebo-controlled oral food challenges (DBPCFC). Witmer et al. analyzed two data sets: 1) subject's ED was predicted by matching their epitope map to the closest epitope map in each of the ED sensitivity subtypes across the complete cohort; and 2) classifiers for determining whether a subject's cumulative ED was ≤143 mg threshold and ≥443 mg threshold peanut protein were developed for individual epitope biomarkers: ara h1-h3, h8, h9, serum IgE to peanut, and logistic regression models of multiple peptide biomarkers. The performance characteristics data was compared in terms of predicting as to whether any given individual is likely or unlikely to have an objective allergic reaction at a specific dose. Witmer et al. found that 95% of subjects were mapped to the correct ED level +/-one dosing level and that 19 subjects underwent repeat DBPCFC around 1 year later, with 90% (17/19) of the subjects having an ED +/- one dosing level and collected optimal multiple peptide biomarker classifiers for determining ED. Witmer et al. teach that the logreg model predicted an ED ≤143 mg with AUC 0.89, NPV 80%, and PPV 94%. and an ED ≥443 mg with AUC 0.93, NPV 73%, and PPV 89%. Witmer et al. concluded that epitope mapping by BBEA was able to predict ED (+/- one dosing level) at DBPCFC for 95% of participants and suggested that BBEA provides a relatively accurate and reproducible method in determining a patient’s reaction threshold. See entire document and Table 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have incorporated the teaching of Witmer in using epitope mapping via BBEA to classify different peanut peptide reactivities to serum IgEs into the BBEA method taught by Getts to select and combine the SEQ ID NO. 1 peptide and the SEQ ID NO. 2 peptide to determine a threshold CRD of a peanut protein in a subject because Getts taught using one or more peanut peptide biomarkers including SEQ ID NO. 1 and showed SEQ ID NO. 2 as a further peanut peptide biomarker in Table 2 and Witmer taught that optimal multiple peanut peptide biomarker classifiers in BBEA shows advantage in providing a relatively accurate and reproducible method in determining thresholds for a subject’s CRD. It is further submitted that multivariant analysis of two or more known predetermined protein biomarker combinations using BBEA such as shown by Getts as modified by Witmer can significantly enhance the accuracy and reproducibility of determining a subject’s reactivity to peanut allergy which is precisely the power of multivariant analysis.
As to incorporation and application of the teaching of Witmer into software algorithms in claims 22 and 23; it is deemed that "[T]he adaptation of an old or known idea or invention such as the combined teachings of Getts and Witmer using newer technology in the form of programmed software algorithm that is commonly available and understood in the art" would be obvious to persons of ordinary skill in that art. Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007)."
It is proper for purposes of the obviousness rejection to interpret the combined teachings of Getts and Witmer in acquiring combined binding values of the SEQ ID NO. 1 peanut peptide and the SEQ ID NO. 2 peanut peptide and measuring reaction thresholds to arrive at determining CRD in a subject using conventional software algorithms applied in BBEA methods because unpatented claims are given the broadest reasonable interpretation consistent with the specification.
8. No claims are allowed.
Remarks
9. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Turner et al. (Increase in IgG4 following peanut Oral Immunotherapy is primarily limited to a single specific epitope against Ara h 2. Journal of Allergy and Immunology 145 (2): Supp Supplement pp AB339 (February 2020)) teach using BBEA in epitope mapping to evaluate changes in epitope profile of IgE and IgG4 during peanut oral immunotherapy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
April 14, 2026
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