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 species in A), B), and C), without traverse, filed October 15, 2025 is acknowledged and has been entered. Applicant elected Species A) chaotropic salt: Magnesium Chloride, Species B) chaotropic salt cation: Magnesium, and Species C) chaotropic salt anion: Chloride. Currently, claims 1-15 are pending.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a). The application is a continuation of PCT/EP2021/061929 filed 05/06/2021 which claims the benefit of foreign application EUROPEAN PATENT OFFICE (EPO) 20173599.0 filed 05/08/2020. Based on the filing receipt, the effective filing date of the instant application is May 8, 2020 which is the filing date of (EPO) 20173599.0 from which the benefit of foreign priority is claimed.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
4. The disclosure is objected to because of the following informalities: in this case, a brief description of the drawings appears to be missing.
Appropriate correction is required.
Information Disclosure Statement
5. The listing of references in the specification at pages 26 and 27 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
6. Claims 4-15 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim and/or should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claims 4-15 have not been further treated on the merits.
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.
7. Claims 1-3 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, step a) in lines 1-2 is indefinite in reciting “in the range of and including 1 N to 12 N” because the recitation of “and including” appears to encompass further values outside the range of 1 N to 12 N, the metes and bounds of which is unclear; thereby, rendering the scope of the claim unascertainable.
Claim 1, step b) is vague and indefinite in reciting “adding a tracer antibody to the sample … to form a tracer antibody-target antibody complex” because it fails to clearly define how the tracer antibody binds the target antibody so as to form the tracer antibody-target antibody complex. Does the tracer antibody bind to the Fc portion of the target antibody in forming the claimed complex in b)?
Claim 1, step c) is further vague and indefinite in reciting “incubating the tracer antibody-target antibody complex … with a detection antibody … to form a tracer antibody-target antibody-detection antibody complex” because it fails to clearly define which antibody component between the tracer antibody and the target antibody in the tracer antibody-target antibody complex formed in b) the detection antibody binds to so as to form the claimed complex c). Does the detection antibody bind specifically or selectively to the target antibody or the tracer antibody?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “a medium strength chaotropic salt,” and the claim also recites “preferably with a cation between potassium and calcium in the lyotrophic series … and an anion between hydrogen phosphate and nitrate in the lyotrophic series….” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
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.
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.
8. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (US 2020/0300852 A1) in view of Tsang et al. (Optimum dissociating condition for immunoaffinity and preferential isolation of antibodies with high specific activity. Journal of Immunological Methods 138: 291-299 (1991)- IDS) and THERMO FISHER INC. (Optimize elution conditions for immunoaffinity purification. TECH TIP Number 27 (Product Spec Sheet TR0027.1: 1-2 (2009)- IDS).
Dahl et al. disclose a method for the detection of a target antibody in a sample; wherein the target antibody is an anti-drug antibody (ADA) or a therapeutic antibody [0128]. The method comprise incubating the sample with a capture antibody conjugated to biotin and tracer antibody conjugated to digoxigenin (i.e. label) to form a capture antibody-target antibody-tracer antibody complex. The method further comprises incubating the capture antibody-target antibody-tracer antibody complex with a detection antibody in the form of anti-digoxigenin antibody that specifically binds to the digoxigenin label of the tracer antibody; wherein the anti-digoxigenin detection antibody is conjugated to a detectable enzyme label. Dahl et al. further teach adding a substrate to the complex mixture in order to detect and indicate the presence of the target antibody that formed a complex with the tracer antibody and the detection antibody in the tracer antibody-target antibody-detection antibody complex [0130-0133, 0140].
Dahl et al. differ from the instant invention in failing to teach incubating the sample with a chaotropic agent at a final cation charge normality in the range of 1 N to 12 N.
Tsang et al. teaches using magnesium chloride (MgCl2) as a chaotropic agent (dissociation or elution reagent) for immune complexes (Abstract; Table 1). According to Tsang et. al. dissociation reagents can be selected for their ability to perturb all or parts of the physical forces needed for the maintenance of immune complexes (p. 293, left col. 1st full ¶).
THERMO FISHER INC. teaches that appropriate buffer conditions for binding and elution steps in affinity purification are as varied as the types of molecules concerned and their chemical binding properties. According to THERMO FISHER INC, the type of elution condition (pH, ionic strength, chaotrope, or denaturant) is most effective for a particular antibody-antigen interaction depends on the specific composition of ionic or cationic, hydrophobic, and hydrogen bonds involved; and that a chaotrope is a salt that disrupts the structure of water and is often related to ionic or cationic strength and denaturing effects (Introduction). In Table 1, THERMO FISHER INC shows the ionic strength and chaotropic effects of MgCl2, lithium chloride (LiCl), as well as sodium chloride (NaCl) and potassium chloride (KCl) to summarize elution conditions in accordance to Hoffmeister series commonly used for immunoaffinity purification.
With respect to the cationic charge of 1 N to 12 N in claim 1; generally, the differences in concentrations and ionic or cationic strengths will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating that such concentrations or temperatures are 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.). ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). Since Applicant has not disclosed that the specific limitation recited in instant claim 1 is for any particular purpose or solve any stated problem and the prior art teaches that reagent parameters such as concentrations and properties required often vary according to the sample being analyzed, and various matrices, solutions and parameters appear to work equally as well; absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures.
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 teachings of Tsang and THERMO FISHER INC. in using chaotropic agents for optimal dissociation conditions for immunoaffinity purification into the anti-drug antibody assay method of Dahl because both of Tsang and THERMO FISHER INC provide that appropriate elution or dissociation conditions are needed for effective antibody binding interactions in immune complexes. One of ordinary skill would have had reasonable expectation of success in combining the teachings of Tsang and THERMO FISHER INC with the method of Dahl because all of Dahl, Tsang, and THERMO FISHER INC. teach analogous art involving immune antibody interactions.
9. No claims are allowed.
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
November 14, 2025