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 .
Priority
This application is a 371 of PCT/US2022/046216 10/11/2022 which claims benefit of
63/254,284 10/11/2021. Based on the filing receipt, the effective filing date of this application
is October 11, 2021 which is the filing date of 63/254,284 from which the benefit of priority is
claimed.
Information Disclosure Statement
The information disclosure statement filed 04/09/2024 has been considered.
Status of Claims
Claims 1-16 are pending and examined herein.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites, “Brain Natriuretic Peptide, and D-Dimer, immunosuppression drugs, Tacrolimus;”. The claim should recite, “Brain Natriuretic Peptide,,”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-8 are 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. See MPEP 2163.
The claims are directed to antibodies and aptamers for binding “immunosuppression drugs” (claim 3) and antibodies and aptamers “effective to impedimetrically detect simultaneously a plurality of biomarkers in the bodily fluid sample” (claim 7). The claims impose no restriction on the size or structure of the antibodies and antibodies other than their binding specificity.
The scope of the claims therefore covers methods comprising a large genus of aptamers and antibodies characterized by substantial variability.
Regarding the predictability or unpredictability in the art, antibodies can often be functionally promiscuous or multi-specific which can lead to antibodies binding to more than one antigen, as evidenced by Jain (“Antibody specificity and promiscuity”, published 2019-02-05). Regarding aptamers, Liu (“The specificity and selectivity of aptamer depends on the binding epitope: insights from aptamer Hislxl-2a”, published 2026-06-22) discloses, “due to their structural diversity and the still-limited understanding of their recognition mechanisms, they continue to face challenges related to specificity and selectivity in practical applications” (see, p. 1, under “ABSTRACT”). Due to multi-specificity and challenges related to specificity, antibodies and aptamers possess a level of unpredictability that requires the applicant to provide evidence that they have considered a sufficient number of antibodies and aptamers.
The specification does not disclose the reduction to practice of a sufficient number of specific antibodies and aptamers having the necessary functional characteristics. The specification merely discloses, “It is recognized that complexation and affinity are a matter of degree; however, in this context, ''target-specific" means that the aptamer or antibody binds to the target with a much higher degree of affinity than it binds to contaminating materials. As used herein, the term "binding" refers to an interaction or complexation between the target compound or molecule of interest and the aptamer or antibody. Aptamers or antibodies are used in diagnosis by employing them in specific binding assays for the target compound or molecule of interest” (see, para. spanning p. 16 to p. 17). The specification discloses aptamers for Brain Natriuretic Peptide and TroponinT in example 2, starting p. 28. A tacrolimus antibody was reduced to practice on p. 27-28.
More than specific structure or molecular arrangement, aptamers and antibodies for use in the described method must be able to specifically, simultaneously bind to a “plurality of biomarkers” and “immunosuppression drugs”. The terms "bind specifically" and "specific binding" refer to the ability of an antibody to bind to a target molecular species in preference to binding to other molecular species with which the specific binding agent and target molecular species are admixed. A specific binding agent is said specifically to recognize a target molecular species when it can bind specifically to that target. However, the simultaneous binding of a plurality of biomarkers is not disclosed in the specification.
The applicant suggests art-recognized methods of using antibodies and provides scant examples. However, considering the vast genus of antibodies and aptamers claimed by the invention, there is insufficient disclosure of aptamers and antibodies falling within the claimed genus.
The disclosure of general methods that use antibodies is insufficient to describe the claimed broad genus of aptamers and antibodies. The Federal Circuit addressed an analogous situation in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir. 2004), finding that disclosure of “assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product,” did not satisfy the written description requirement for claims requiring administration of a “compound that selectively inhibits PGHS-2.” Rochester, 119 F.3d at 918, 927; see also Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company, 598 F.3d 1336, 1344 (Fed. Cir. 2010) (recognizing distinction between requirements for written description and enablement).
Furthermore, there is also no disclosure of any partial structure common to the members of the genus of aptamers and antibodies that would correlate with function (in this case, the claimed functions of selectively binding to “immunosuppression drugs” or a “plurality of biomarkers”).
The importance of structure/function correlations was recently highlighted by the courts (Abbvie Deutschland v. Janssen Biotech and Centocor Biologics, App. No. 2013-1338, -1346 (Fed. Cir., July 1, 2014)). The Abbvie case involved antibodies and written description. The court stated: “We have held that “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568– 69).”. The courts then further stated: “With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” (emphasis added) and then state: " Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein). It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002).
There is no partial structure or other identifying characteristics disclosed, common to the members of the genus of aptamers and antibodies having sufficiently high binding affinity, that would allow one skilled in the art to envision that Appellant has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus.
For all of these reasons, the specification does not demonstrate possession of the entire genus of aptamers and antibodies having the claimed functional characteristics of specifically binding to “immunosuppression drugs” or “a plurality of biomarkers”.
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 1, 4-5, 9, 11-12, and 15 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.
Claims 1 and 9 refer to “an immobilization agent” twice. The first recitation of “an immobilization agent” is referring to the application of an immobilization agent to a surface. The second recitation of “an immobilization agent” refers to a component of “a biological sensor agent”. It is unclear whether the immobilization agents are identical in each recitation or are different.
Claims 4 and 15 recite the limitation "the immobilization agent" in the wherein clauses. There is insufficient antecedent basis for this limitation in the claims because claims 4 and 15 depend on independent claims 1 and 9, both of which refer to “an immobilization agent” twice. It is unclear which immobilization agent is referred to by “the immobilization agent”. Therefore, the metes and bounds of the claims cannot be ascertained.
Claim 5 contains the trademark/trade name “neutravidin”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the binding agent and, accordingly, the identification/description is indefinite.
Regarding claim 11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 recites, “correlating the visual change with a chart or key”. It is unclear what method steps would have met this limitation. The specification does not ameliorate the indefiniteness. Therefore, the metes and bounds of the claim cannot be ascertained.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites, “wherein the immobilization agent is a binding agent”. In light of the applicant’s specification and under the broadest reasonable interpretation of “immobilization agent” and “binding agent”, the claim is not further limiting because the two terms have the same meaning. The immobilization agent is a binding agent by definition. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kumta (US 20180292400 A1, published 2018-10-11) in view of Easley (US 10852274 B2, published 2020-12-01).
Kumta teaches a biosensor system to detect biomarkers of interest in a patient and reduce or preclude non-biomarker interference, comprising:
a sensing biosensor, comprising:
a conductive material interface having a surface, and a biological sensor agent applied to the surface of the conductive material interface, the biological sensor agent comprising:
an immobilization agent; and
at least one aptamer or antibody selected to interact with the
immobilization agent and selected to bind with the biomarkers of interest;
a signaling agent comprising an electrochemical impedance signal
generated by binding of the aptamer or antibody with the biomarkers of interest; and
a bodily fluid sample derived from the patient and in contact with at least one aptamer or antibody of the sensing biosensor, wherein the sensing biosensor detects a presence of the cardiac biomarker of interest in the bodily fluid sample, as in claim 1 (see, e.g., biosensor system – under “ABSTRACT”; sensing biosensor – para. [0011]: “An end of the platinum wires serves as the point of contact for the electrochemical impedance signals to be transduced, allowing for an interpretable reading of the output”, and para. [0025]: “The aptasensors are in-vitro (ex-situ) devices that utilize the bodily fluid sample derived from the patient for impedimetric detection of the one or more cardiac biomarkers. The impedance changes are measured using electrochemical impedance spectroscopy (EIS), which is a highly sensitive, label-free technique that allows for changes in electrochemical impedance resulting from the binding of the aptamer to the antigen to be transduced into an interpretable read-out value”, and para. [013]: “The aptamer can be conjugated with biotin. The immobilization agent can be selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof”, and claim 1; signaling agent - para. [0025]: “The impedance changes are measured using electrochemical impedance spectroscopy (EIS), which is a highly sensitive, label-free technique that allows for changes in electrochemical impedance resulting from the binding of the aptamer to the antigen to be transduced into an interpretable read-out value”, and para. [0013]: “The aptamer can be conjugated with biotin. The immobilization agent can be selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof. The immobilization agent can be applied to a treating agent, and the treating agent can be applied to the surface of the conductive material interface including the multi-array of vertically aligned platinum wires”; bodily fluid sample - para. [0025]: “The aptasensors are in-vitro (ex-situ) devices that utilize the bodily fluid sample derived from the patient for impedimetric detection of the one or more cardiac biomarkers”).
Kumta teaches wherein the bodily fluid sample is selected from blood animals or humans, as in claim 2 (see, e.g., para. [0012]).
Kumta teaches wherein the biomarkers are selected from C-reactive protein, Creatinine Kinase, Creatinine Phosphokinase, TroponinT, Myoglobin, IL-6, IL-18, Brain Natriuretic Peptide, and D-Dimer, as in claim 3 (see, e.g., para. [0012]).
Kumta teaches wherein the immobilization agent is a binding agent, as in claim 4 (see, e.g., para. [0013]: “The aptamer can be conjugated with biotin. The immobilization agent can be selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof”).
Kumta teaches wherein the binding agent is selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof, as in claim 5 (see, e.g., para. [0013]: “The aptamer can be conjugated with biotin. The immobilization agent can be selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof”).
Kumta teaches wherein the conductive material interface comprises a multi-array of vertically aligned platinum wires, as in claim 6 (see, e.g., para. [0013]: “The immobilization agent can be applied to a treating agent, and the treating agent can be applied to the surface of the conductive material interface including the multi-array of vertically aligned platinum wires”).
Kumta teaches wherein the aptamer or antibody is effective to impedimetrically detect simultaneously a plurality of biomarkers in the bodily fluid sample (see, e.g., para. [0015]: “The aptamer can be effective to impedimetrically detect simultaneously a plurality of cardiac biomarkers in the bodily fluid sample”).
Kumta teaches wherein the multi-arrays of vertically aligned platinum wires are arranged in a circular configuration, as in claim 8 (see, e.g., para. [0014]: “The multi-array of vertically aligned platinum wires can be arranged on the surface of the substrate in a circular configuration”).
Kumta teaches a biosensing method of detecting biomarkers of interest in a bodily fluid
sample of a patient and to reduce or preclude non-biomarker interference, comprising:
obtaining the bodily fluid sample from the patient;
forming a detection device, comprising:
a sensing biosensor, comprising:
a conductive material interface having a surface, and
a biological sensor agent applied to the surface of the conductive material interface, the biological sensor agent comprising:
an immobilization agent; and
at least one aptamer or antibody selected to interact with the immobilization agent and selected to bind with the biomarkers of interest;
contacting the aptamer or antibody of the sensing biosensor with the bodily fluid sample;
generating an electrochemical impedance signal for each of the sensing biosensor, as in claim 9 (see, e.g., biosensor system – under “ABSTRACT”; sensing biosensor – para. [0011]: “An end of the platinum wires serves as the point of contact for the electrochemical impedance signals to be transduced, allowing for an interpretable reading of the output”, and para. [0025]: “The aptasensors are in-vitro (ex-situ) devices that utilize the bodily fluid sample derived from the patient for impedimetric detection of the one or more cardiac biomarkers. The impedance changes are measured using electrochemical impedance spectroscopy (EIS), which is a highly sensitive, label-free technique that allows for changes in electrochemical impedance resulting from the binding of the aptamer to the antigen to be transduced into an interpretable read-out value”, and para. [013]: “The aptamer can be conjugated with biotin. The immobilization agent can be selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof”, and claim 1; signaling agent - para. [0025]: “The impedance changes are measured using electrochemical impedance spectroscopy (EIS), which is a highly sensitive, label-free technique that allows for changes in electrochemical impedance resulting from the binding of the aptamer to the antigen to be transduced into an interpretable read-out value”, and para. [0013]: “The aptamer can be conjugated with biotin. The immobilization agent can be selected from the group consisting of avidin, streptavidin, neutravidin and mixtures thereof. The immobilization agent can be applied to a treating agent, and the treating agent can be applied to the surface of the conductive material interface including the multi-array of vertically aligned platinum wires”; bodily fluid sample - para. [0025]: “The aptasensors are in-vitro (ex-situ) devices that utilize the bodily fluid sample derived from the patient for impedimetric detection of the one or more cardiac biomarkers”).
Kumta teaches wherein the electrochemical impedance signal is transduced to a read-out value, as in claim 10 (see, e.g., para. [0017]: “The electrochemical impedance signal can be transduced to an interpretable read-out value. The electrochemical impedance signal can be connected to a hand-held device that is effective to display the read-out value”).
Kumta teaches wherein the electrochemical impedance signal is connected to a portable device such as a hand-held device that is effective to display the read-out value, as in claim 11 (see, e.g., para. [0017]: “The electrochemical impedance signal can be transduced to an interpretable read-out value. The electrochemical impedance signal can be connected to a hand-held device that is effective to display the read-out value”).
Kumta teaches wherein the detection device is in the form of a test strip and the method, comprises:
contacting the bodily fluid sample with the test strip;
assessing a visual change to the test strip;
correlating the visual change with a chart or key; and
based on said correlating, determining if the visual change is indicative of
the presence of a change in electrochemical impedance and the presence of the cardiac biomarkers in the bodily fluid sample, as in claim 12 (see, e.g., para. [0018]: “The detection device can be in the form of a test strip and the method, can include contacting the bodily fluid sample with the test strip; assessing a visual change to the test strip; correlating the visual change with a chart or key; and based on said correlating, determining if the visual change is indicative of the presence of a change in electrochemical impedance and the presence of the cardiac biomarkers in the bodily fluid sample”).
Kumta teaches wherein the visual change is a color change, as in claim 13 (see, e.g., para. [0018]: “The visual change can also be a color change”).
Kumta teaches wherein the electrochemical impedance signal is generated as a result of the biomarker of interest interacting with the aptamer or antibody, as in claim 14 (see, e.g., under “ABSTRACT”: “The biosensors are contacted with a portion of the bodily fluid sample, and the aptamer binds to the cardiac markers of interest in the bodily fluid sample. As a result, an electrochemical impedance signal is generated and therefore, a change in electrochemical impedance is indicative of the presence of the cardiac markers of interest in the bodily fluid sample”).
Kumta teaches wherein prior to applying the immobilization agent, the surface of the conductive interface material is treated with a thiol-based compound, as in claim 15 (see, e.g., para. [0033]: “The surface then can be treated with a thiol-based compound, such as, an aminothiol, including but not limited to, cysteamine and/or glutaraldehyde”).
Kumta teaches wherein the thiol-based compound is an aminothiol selected from cysteamine and/or glutaraldehyde, as in claim 16 (see, e.g., para. [0033]: “The surface then can be treated with a thiol-based compound, such as, an aminothiol, including but not limited to, cysteamine and/or glutaraldehyde”).
Kumta fails to teach a baseline biosensor, comprising:
an electrically conductive material interface having a surface, an immobilization agent applied or deposited onto the surface of the conductive material interface; and biotin conjugated with the immobilization agent; wherein the baseline biosensor detects interference in the bodily fluid sample, and the sensing biosensor detects a presence of the cardiac biomarker of interest
in the bodily fluid sample; and a correction applied to the baseline biosensor and the sensing biosensor to reduce or preclude non-biomarker interference from the bodily fluid sample, as in claims 1 and 9.
However, Easley teaches a baseline sensor to remove background noise, as in claim 1 (see, e.g., col. 1, lines 48-67: “According to one aspect of the disclosure, an apparatus for target molecule detection includes a sample cell configured to receive a sample, a reference electrode in communication with the sample cell, a counter electrode in communication with the sample cell, a first working electrode, a second working electrode, and a differential amplifier circuit. The first working electrode is in communication with the sample cell and is coated with a first recognition element that is to interact with a target molecule in the sample. The first working electrode is configured to measure a first signal responsive to interaction of the first recognition element with the target molecule. The second working electrode is in communication with the sample cell is not coated with the first recognition element. The second working electrode is configured to measure a second signal indicative of background noise from the sample. The differential amplifier circuit is configured to generate a modified signal that is proportional to a difference between the first and second signals. The modified signal indicates an amount of the target molecule present in the sample”).
Kumta and Easley are analogous to the field of the claimed invention because they are both in the field of electrochemical sensors. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to remove the recognition element of Kumta as taught by Easley. An artisan would have been motivated to do so because Easley discloses “Accounting for background noise with the conventional potentiostat 10 is difficult” (see, col. 5, lines 30-31) and “The second working electrode is in communication with the sample cell is not coated with the first recognition element. The second working electrode is configured to measure a second signal indicative of background noise from the sample. The differential amplifier circuit is configured to generate a modified signal that is proportional to a difference between the first and second signals. The modified signal indicates an amount of the target molecule present in the sample” (see, col. 1, lines 59-67). An artisan would have had a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
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/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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