DETAILED ACTION
Notice of AIA Status
The present application, filed on 12/24/2022, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are pending.
Claims 1-6 and 13-20 are withdrawn.
Claims 7-12 are rejected.
Election/Restrictions
Applicant's election with traverse of Group II, claims 7-12, in the reply filed on 3/30/2026 is acknowledged. The traversal is on two separate grounds. The first ground is that there is a lack of serious burden and the second ground is Johnson does not teach or suggest authentication of sample volume, buffer sequence validation, or integration of validation zones as claimed and does not disclose authentication of sample volume via a validation membrane of fixed thickness, validation of buffer sequence and timing using imaging/video analysis, and integration of sample authentication and analyte detection in a single device.
However, neither ground is persuasive. The first ground is not found persuasive because the reason for restricting of the instant applicant filed under 35 U.S.C. §371 is not due to a lack of serious burden. As a result, serious burden considerations are moot. The second ground is also not found persuasive because groups I, II, III, IV, V, VI, VII and VIII lack unity of invention because even though the inventions of these groups require the technical feature of an immunoassay, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Johnson (US20170191996) which teaches an immunoassay (see [0009], which recites “EtG immunoassay lateral flow test strips, devices, methods, and/or reagents”).
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections under 35 U.S.C. § 112
Claims 7-12 are rejected under 35 U.S.C. §112 (b) as being indefinite for failing to particularly point out and distinctly claim 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(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 preamble of claim 7 recites “a method for performing authentication of a biological sample in an immunoassay device while performing an assay for a plurality of analytes of interest”. However, the body of claim 7 neither recite an authenticating a biological sample step nor a performing an assay for a plurality of analytes of interest. As a result, the limitation in the preamble renders claim 7 indefinite because it isn’t clear what step in the body of claim 7 comprises performing authentication of a biological sample in an immunoassay device and because it isn’t clear what step in the body of the claim 7 comprises performing an assay for a plurality of analytes of interest.
Claim 7 recites “chemicals/reagents/antibodies”. The limitation renders the claim indefinite because it isn’t ambiguous whether the limitations are alternatives or whether all three elements are cumulatively required. Consider rephrasing to ‘one selected from the group consisting: one or more chemicals, one or more reagents, and one or more antibodies, or a combination thereof’.
Claim 7 recites “allowing (404a) the biological sample to pass through a validation zone (102) on to a sample zone (104) or allowing (404b) the biological sample to pass to the validation zone (102) via the sample zone (104) or allowing (404c) the biological sample to split with one part going into the validation zone (102) and other part on to a reaction zone (108)”. The limitation renders claim 7 indefinite because it isn’t clear whether claim 7 encompasses using one of multiple immunoassay device each with a single path or encompasses a single immunoassay device and controlling a single path of the single device comprising multiple paths. In addition, it isn’t clear whether the limitation ‘allowing…’ comprises a further step of controlling flow in a single device or merely permits passive flow in alternative devices.
Claim 7 recites “a coloured, florescent or electrochemical reaction … imaging the coloured or fluorescent reaction to …”. The limitation renders claim 7 indefinite because it isn’t clear what the scope of imagining is when the caused reaction is an electrochemical reaction. Consider rephrasing to ‘a coloured reaction, a fluorescent reaction or a electrochemical reaction to … imaging the coloured reaction, the fluorescent reaction or the electrochemical reaction to …’ or to ‘a coloured reaction or a florescent reaction … imaging the coloured reaction or the fluorescent reaction to …’
Claim 8 recites “allowing (406b) the biological sample to pass through a conjugate zone (106)”. The limitation renders claim 8 indefinite because it isn’t clear whether limitation requires a further step of controlling flow or merely permits passive flow within alternative devices.
Claim 10 recites “primary antibodies/reagents … with secondary antibodies/antigens/reagents”. The limitation is ambiguous because it isn’t clear whether “/” means “and” or “or”.
Claim 10 recites “cause a coloured, fluorescent or electrochemical reaction”. It isn’t clear whether the “coloured, fluorescent or electrochemical reaction” correspond to the “coloured, fluorescent or electrochemical reaction” in claim 7 or something else. If the limitation in claim 10 is the same recited in claim 7, consider rephrasing to the limitation in claim 7 to “a coloured reaction, a fluorescent reaction or an electrochemical reaction’ and the limitation in claim 10 to “the coloured reaction, the fluorescent reaction or the electrochemical reaction”. If the limitation in claim 10 is different from the limitation in claim 7 consider rephrasing the limitation in claim 7 to “a first coloured reaction, a first fluorescent reaction or a first electrochemical reaction’ and the limitation in claim 10 to “a second coloured reaction, a second fluorescent reaction or a second electrochemical reaction”.
Claim 12 recites “electing a criterion for validation of the biological sample based on the detection of plurality of biological markers”. The limitation renders claim 12 because the limitation is no more than a purely mental act which is problematic because the electing is not objectively verifiable and isn’t tied to a concrete act.
Claim 12 recites the limitation "the detection of plurality of biological markers". There is insufficient antecedent basis for this limitation in the claim.
As a result, a person of ordinary skill in the art wouldn’t be reasonably apprised of the scope of the claimed invention.
Claims dependent on an indefinite base claim are indefinite because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
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 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Messmer (US20150293086).
With respect to claim 7, Messmer (US20150293086) teaches a method (400) for performing authentication of a biological sample in an immunoassay device (see claim 30, which recites “a method of determining the integrity of a biologic”) (the Meriam dictionary defines ‘to authenticate: to prove or serve to prove to be real, true, or genuine’, the broadest reasonable interpretation of performing authentication of a biological sample in a immunoassay device includes determining the integrity of a biological sample because determining the integrity of the biological sample in the context of an immunoassay necessarily results in authentication. A biologic that does not retain its defining structural or functional characteristics would not be recognized as the authentic biologic) (see [0034], which recites “the term “biologic” as used herein refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine”) while performing an assay for a plurality of analytes of interest (see [0030], which recites “more than one test line is applied for multi-analyte testing”), (the method) comprises:
adding (402) the biological sample to the immunoassay device (test device in claim 30, which “contacting the biologic with a test device”)(see claim 31, which recites “the test device is a lateral flow immunoassay”) (see [0046], which recites “In one embodiment, the sample pad of the test device receives a protein in a fluid selected from the group consisting of buffer, saline solution, pharmaceutical composition, and biological fluid. In another embodiment, the biological fluid received by the sample pad is selected from a group consisting of: blood, urine, lacrimal fluid, sweat, saliva, and amniotic fluid”);
allowing (404a) the biological sample to pass through a validation zone (102) on to a sample zone (104) or allowing (404b) the biological sample to pass to the validation zone (102) (control line αKappa in Fig. 1) via the sample zone (104) (sample pad in Fig. 1) or allowing (404c) the biological sample to split with one part going into the validation zone (102) and other part on to a reaction zone (108);
reacting (406a) the biological sample with chemicals/reagents/antibodies to cause a coloured, fluorescent or electrochemical reaction (see [0030], which recites “The term “test line” as contemplated herein, refers to a band or zone on the test membrane that contains at least one mimetope peptide. The mimetope peptide is usually immobilized in a band or zone such that after reaction with the antibody-detectable marker complex, the band or zone produces an observable or measurable signal reflecting the presence or amount of antibody present in the sample”); and
imaging (408) the coloured or fluorescent reaction to authenticate the biological sample (see [0036], which recites “the test device includes qualitative readout (e.g., presence/absence of a specific protein). … quantitative results is achieved by including a series of test lines of mimetopes of increasing concentration ….the signal is digitized and evaluated using a flatbed scanner or a CCD camera and appropriate software. … chemiluminescent or fluorescent labels are optionally used to increase the sensitivity”).
With respect to Claim 8, Messmer teaches the method as claimed in claim 7 further comprises allowing (406b) the biological sample to pass through a conjugate zone (106) (Conjugate Pad in Fig. 1) (see [0014], which recites “the sample comprising an antibody flows through a conjugate pad”).
With respect to Claim 9, Messmer teaches the method as claimed in claim 7, wherein the biological sample is a bodily fluid (see [0046], which recites “the sample pad of the test device receives a protein in … biological fluid”) (see [0025], which recites “the term “biological fluid” as used herein contemplates a liquid with biomolecules, bioparticles, blood, sweat, saliva, amniotic fluid, lacrimal fluid, or urine”).
Allowable Subject Matter
Claims 10-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
With respect to Claim 10, Messmer teaches the method as claimed in claim 7.
Messmer doesn’t teach authenticating a buffer by conjugating a plurality of constituents of buffer with labels conjugated with primary antibodies/reagents to obtain conjugated buffer; and reacting the conjugated buffer with secondary antibodies/antigens/reagents with the primary antibodies conjugated with labels to cause a coloured, fluorescent or electrochemical reaction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN BORTOLI whose telephone number is (571)270-3179. The examiner can normally be reached 9 AM till 6 PM EST Monday through Thursday.
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/JONATHAN BORTOLI/Examiner, Art Unit 1797 /JENNIFER WECKER/Primary Examiner, Art Unit 1797
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