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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the species of peanuts in the reply filed on 7 April 2026 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions/species, there being no allowable generic or linking claim.
Claims 1-13 are examined upon their merits.
Priority
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. This application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63/343,276, filed on May 18, 2022.
Claims 1-13 have an effective filing date of 18 May 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 January 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-5 are objected to because of the following informalities: These claims each contain abbreviations that are not spelled out in their first appearance within the claims (ex. IgG, bPG, SA, etc.). Appropriate correction is required.
Claim 5 is further objected to because it recites “at a tIgG:PG molar ratio of 2.0”, which is assumed to be “at an IgG:PG molar ratio…” but 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.
Claims 7-8 and 11-13 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 7 uses the “quick spin centrifugation” which a relative term which renders the claim indefinite. The term “quick” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree what constitutes “quick spin” as opposed to any other types of centrifugation spinning. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 8 recites “using a 10nm filter”; Claims 11 and 12 recite “using a biolayer interferometry system”. MPEP 2173.05(q) states: “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.” The case law applies to the instant claims which recite: “using a …filter” or “using a biolayer interferometry system” without setting forth any active, positive steps delimiting how these uses are actually practiced. This affects all depending claims.
Further, claim 12 is indefinite wherein it recites, “is configured to detect binding of a gold nanoparticle to a sensor”. It is unclear what material/structural limitation “configured to…” imposes. Additionally, it is unclear what active method steps are encompassed by “configured to detect binding…”. This affects the scope of depending claim 13.
Claim Rejections - 35 USC § 102
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 1-2 and 9-10 are rejected under rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al., J Allergy Clin Immunol., 134(6): 1339–1345, 2014.
Regarding claim 1, the Song et al. prior art teaches a method of allergen testing comprising: obtaining a subject sample, specifically, Song et al. collect sera from blood (pg. 4, Measurement of peanut-specific antibodies). The prior art teaches: “To measure serum peanut-specific IgE, serum IgG antibodies were first depleted by protein G–Sepharose (BioVisio, Milpitas, CA) centrifugation”, which teaches depleting IgG in the subject sample. The Song prior art further teaches, “Peanut-specific IgE levels in protein G–depleted sera were measured using previously described ELISA methods.(37;38)”. This teaches the claimed, “determining a level of IgE specific to an allergen in the subject sample”.
Regarding claim 2, Song et al. teach adding an IgG binder, namely Protein G) to the subject sample; and adding an IgG binder aggregator, namely, Sepharose beads, to the subject sample (pg. 4, Measurement of peanut-specific antibodies).
Regarding claim 9, Song et al. teaches “the subject sample comprises serum isolated from blood”, which teaches the blood and serum of the instant claims.
Regarding claim 10, Song et al. teaches the instantly-elected peanut allergen (Abstract).
Thus, the method of the invention fails to distinguish over the methods disclosed in the prior art.
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.
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al., J Allergy Clin Immunol., 134(6): 1339–1345, 2014; taken with Thermofisher product sheet for Recombinant Protein G, Biotinylated, published online 16 September 2019; and Lee et al., Immunology, 97:232-240, 1999.
The teachings of Song et al. as they pertain to claims 1 and 9-10 are outlined in the rejection above. The Song et al. prior art teaches a method of allergen testing comprising: obtaining sera from blood samples, measuring serum peanut-specific IgE, serum IgG antibodies by first depleting by protein G–Sepharose (BioVisio, Milpitas, CA) centrifugation, measuring peanut-specific IgE levels in protein G–depleted sera by ELISA methods, that were previously published (citing the Lee et al. reference).
Regarding claim 3, the method of Song et al. prior art comprise Protein G depleted serum but it does not teach the “bPG”, which the specification defines as “biotinylated Protein G”(paragraph [0017]), of instant claim 3. However, the Thermofisher product sheet remedies this deficiency. The product sheet teaches Recombinant Biotinylated Protein G (hereafter bPG) was commercially available prior to the effective filing date of the application. A person having ordinary skill would have been able to substitute this bPG for the Protein G used in the method of Song et al. Motivation to use this recombinant bPG is explicit in the Thermofisher product sheet wherein it states it can be used in “ELISA techniques” and confers distinct advantages over Protein G, stating: “native Protein G identifies two IgG-binding domains and sites for albumin and cell surface binding. The albumin and cell surface binding domains have been eliminated from Recombinant Protein G to reduce nonspecific binding and, therefore, can be used to separate IgG from crude samples … Because Protein G has greater affinity than Protein A for most mammalian IgGs, it may be used for the purification of mammalian IgGs that do not bind well to Protein A. Protein G binds with significantly greater capacity than Protein A to several IgG subclasses such as human IgG3”. Thus, the bPG is performing the same function as the Protein G in the Song et al. method (depleting IgG) and a person having ordinary skill would have been able to use bPG with predictable success to separate IgG from crude samples.
Regarding claim 4, while the Song et al. prior art teaches ELISA methods for the detection of peanut-specific IgE and IgG it refers to the Lee prior art for the specific methodology. Song et al. fails to teach streptavidin, which the instant specification defines as the “SA” IgG binder aggregator of instant claim 4 (paragraph [0018]). The Lee et al. prior art remedies this deficiency by teaching the method of Song comprises “After further washes, streptavidin-conjugated alkaline phosphatase ( 1 : 2000, Sigma, St Louis, MO) was added for an additional 2 hr at room temperature. After extensive washing, wells were developed by phosphatase substrate p-nitrophenyl phosphate (pNPP) and absorbance at 405 nm was determined using a microplate reader. The levels of antibody were compared with IgGl, IgE and IgG2a standards with predetermined concentrations” (pg. 234, first full paragraph). Thus, the method of Song comprises the SA of the instant claim.
Regarding claim 5, which recites, “wherein bPG is added at a tIgG:PG [sic] molar ratio of 2.0 and SA is added at a PG:SA molar ratio of 2.0”. Neither the Song et al. or the Lee et al. disclose the specific ratios of IgG:PG or PG:SA, the courts have stated that, generally, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
MPEP 2144 sets forth Applicant's burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount. In the instant case, the specification as filed provides no evidence that the particular amount or range recited within the claims is critical because the 2.0 ratio of the instant claims appears to be an exemplary value within the specification as filed rather than a critical element (see paragraph [0019]).
Regarding claims 6 and 7, the method of Song et al. teaches further comprising removing compounds from the subject sample “as a function of their size” (instant claim 6), wherein it teaches protein G–Sepharose and serum were mixed and incubated at room temperature for 10 minutes, then centrifuged at 1200 rpm for 10 minutes at room temperature (pg. 4, Measurement of peanut-specific antibodies). Centrifugation separates particles by size and density. This method also teaches the “quick spin centrifugation” requirement of instant claim 7.
Thus, the invention of the instant claims is obvious in view of known methods disclosed in the prior art, and in view of alterations in those methods made through routine experimentation.
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al., J Allergy Clin Immunol., 134(6): 1339–1345, 2014 as applied to claims 1-2 and 9-10 above, and further in view of Gomez-Arribas et al., Sensors, 18:1087, published 4 April 2018.
The teachings of Song et al. as they pertain to claims 1-2 and 9-10 are outlined in the rejection above. The Song et al. prior art teaches a method of allergen testing comprising: obtaining sera from blood samples, measuring serum peanut-specific IgE, serum IgG antibodies by first depleting by protein G–Sepharose (BioVisio, Milpitas, CA) centrifugation, measuring peanut-specific IgE levels in protein G–depleted sera by Enzyme-Linked Immunosorbent Assay (ELISA) methods. In a standard sandwich ELISA, a biotinylated detection antibody binds to a target protein. Avidin/streptavidin is linked to an enzyme (like HRP), and when added, the avidin binds tightly to the biotin, tethering the enzymes to the detection antibody. Detection is performed using the enzyme to catalyze a colorimetric or fluorescent signal.
Song et al. is silent with respect to determining the level of IgE specific to the allergen in the subject sample comprising a biolayer interferometry system (instant claim 11); wherein the biolayer interferometry system is configured to detect binding of a gold nanoparticle to a sensor (instant claim 12).
The Gomez-Arribas et al. prior art, however, remedies these deficiencies. Gomez-Arribas teach food allergen detection comprising biosensors and particularly, gold nanoparticles (pg. 8, second paragraph under bullet 3). Figure 1 of the prior art depicts the schematic by which nanoparticles are used, and a key feature of the mechanism is the use of tetrameric avidin and a biotin-labelled nanoparticle. The prior art further discloses the development of an optical immunochip using AuNPs as signal transducers in a highly sensitive interferometric setup (pg. 21, last paragraph). Table 6 of Gomez-Arribas et al. teaches Interferometric Reflectance Imaging Sensor methods for the detection of the Ara h 1 peanut allergen. Specifically, the table teaches a sandwich assay comprising a biotinylated Ara h 1 aptamer and gold nanoparticles (“AuNP” of the reference) decorated with anti-Ara h 1 antibody (see pg. 11 for discussion of these experiments). Both Song and Gomez-Arribas disclose Ara h 1 is an IgE-binding epitope.
It would have been obvious to a person having ordinary skill in the art that the sandwich assay comprising a biotinylated Ara h 1 aptamer and gold nanoparticles decorated with anti-Ara h 1 antibody, and detected by Interferometric Reflectance Imaging Sensor, could be substituted for the ELISA assay disclosed in Song. Given the guidance and direction in each reference, a person having ordinary skill in the art of food allergen immunoassays, would have been able to combine the elements according to known methods and predictably detect IgE that bind peanut epitopes.
Thus, the method of instant claims 11-12 is rendered obvious by the methods disclosed in the prior art.
Conclusion
No claims is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
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