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 .
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.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/GB2021/052451, filed 09/21/2021. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2014880.5, filed on 09/21/2020 in the United Kingdom.
Information Disclosure Statement
The information disclosure statement (IDS) filed 03/21/2023 is considered, initialed and is attached hereto.
Status of the Claims
Claims 1-2, 4, 7-10, 12-18, 20-22 and 24 are pending; claims 3, 5-6, 11, 19, 23 and 25 are canceled; claims 1, 4, 7-10, 12-18, 20-22 and 24 are amended. Claims 1-2, 4, 7-10, 12-18, 20-22 and 24 are examined below.
Claim Objections
Claims 2, 4, 7-9, 12, 15-18 and 20-22 are objected to because of the following informalities:
Claims 2, 4, 7-9, 12, 15-18 and 20-22 each recite the language “the method according to claim 1” in referring back to the independent claim which they are intended to further limit. The claims are objected to because the term “according to”, while suggesting conformity with, does not clearly state that all the claimed elements/steps are referenced. It is suggested that applicant amend claim language to recite “the method of claim 1” so that there is no ambiguity that the claim refers back to the independent claim including all of its steps and limitations, and as such improving clarity of the record.
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 1-2, 4, 7-10, 12-18, 20-22 and 24 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 recite at step IV) “releasing…iii. unbound capture agent, wherein the capture agent is released from the surface”, the claim language is indefinite because it is not readily clear what “unbound” is in reference to in terms of “unbound capture agent”. It appears this language is intended as capture agent at the surface that did not bind biomarker in the sample. If this is Applicant’s intended meaning, then it is suggested Applicant amend in order to make the language clear.
See similarly claim 10 at step IV), iii, the same issue as discussed above also applies at claim 10, as a result claim 10 is similarly indefinite.
Claims 4 and also claim 7 each recite “a detection area (see claim 4, “application of a release agent to a detection area”, claim 7, “a detection area of the surface”), the language “a detection area” is indefinite claims language because claim 1 from which 4 depends previously recites “a first detection area”. As a result, it is not clear if “a detection area” at claim 4 is in reference to “the first detection” area of claim 1 or some other detection area.
Claim 8 recite “determining the number of particles of the expected mass or contrast released from the surface”, it is not clear what is meant by “the contrast” or what characteristic “the contrast” is in reference to/represents.
Claim 8 recites the limitation "the expression product" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. It is not clear what “expression product” the claim is making reference to, since the claim fails to earlier recite an expression product.
Claim 8 also recites “the method comprises i) determining the expected mass of the particle of claim 1, determining the number of particles of the expected mass or contrast released from the surface, and optionally iii) comparing the results of ii) to a standard curve”, the recited language is indefinite because one cannot readily determine what is encompassed/how to perform the recited steps at this claim. For example, it is not clear what steps are performed (encompassed by this language) in determining the expected mass of a particle, and what steps are involved in determining the number of the particles of the expected mass such to fairly compare it to the closest prior art (however, upon clarification, further prior art rejection may apply later during examination). The claim is confusing because it would be expected that following claim 1, detecting release and determining a change in light scattering would result in an obtained signal/output, and then this output signal is what would be used in a comparison step to determine/extrapolate a determined number. The originally filed specification fails to clarify the recited language, see for example, only at page 9 of the originally filed specification refers to the expected mass of the biomarker, but provides no additional context relative to the claim.
Claim 10 recites “optionally wherein said method is defined in claim 1”, however claim 10 repeats all the same steps as recited at claim 1. It is unclear what is meant by “repeats all the same steps as recited at claim 1” since claim 10 already recites steps consistent with claim 1.
Claim 12 recites “providing a surface” and “immobilizing on the surface a capture agent”, however, claim 12 depends from claim 1 and claim 1 already recites an active step of providing a surface (see at I) providing in solution a surface comprising a capture agent”) and also already recites “immobilised” capture agent (see at I), a capture agent “immobilised thereon”). As a result, claim 12 is indefinite because it does not clearly refer back to the same surface as at claim 1 and the same immobilized capture agent as at claim 1.
Claim 14 recites “the method comprising a method of diagnosis as defined in claim 10”, the language “a method of diagnosis” and “as defined by” are indefinite claim language because it is not clear that applicant is referring to diagnosis as achieved by the method of claim 1, rather “a method as defined in claim 10”, the language does not clearly limit to the method of the earlier claim. It is suggested that Applicant amend the language to recite something such as “The method of claim 10, further comprising selecting a subject…” or some other language that clear refers to the earlier claimed method at claim 10.
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 17 recites the broad recitation an “organic or in organic chemical”, and the claim also recites “protein a fragment thereof, a peptide, a polypeptide, a proteoglycan, a glycoprotein, a lipoprotein a carbohydrate, a lipid, a nucleic acid”, all of which are the narrower statement of the range/limitation (similarly “peptide” and “polypeptide” are narrower limitations of “protein fragment”. 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 claims.
Claim 18 recite “to release a biomarker”, the language “a biomarker” is indefinite because the earlier claims from which 18 depend already refer to a biomarker, as such it is not clear if the claim is in reference to the biomarker of the earlier claims, or for example another additional/or other biomarker.
Claim 21 recites “detecting interactions between two or more biological molecules in a sample comprising a method according to claim 1, wherein the biomarker is indicative of the presence of an interaction between the two or more molecules”, the claim is indefinite because it is unclear from the recited language if the biomarker is one of the claimed “biological molecules”, or if biomarker is distinct from the claimed biomarkers. As a result, the claim language is indefinite because it is not readily clear what is and is not encompassed by the recited language.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4, 7-9, 12-13, 17-18 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas
Claims 10 and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Regarding the abstract ideas recited at claim 1, see the claim recites comparison steps, for example see at step V), “determining the change in light scattering in the surface”, this limitation is referring to the change observed at the test surface between the measurement taken following the binding step and the release step.
Such a comparison step is categorized as an abstract idea (see MPEP 2106.04), namely a mental process/concept performed in the human mind (such as a practitioner performing the assay simply thinking about the measured level relative to the earlier measured level and making an evaluation, judgment or an opinion). The claims, under their broadest reasonable interpretation, cover performance of the determination solely within the human mind.
Similar concepts involving comparing information regarding have been held to be an "abstract mental process", as in University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014) which involved "comparing BRCA sequences and determining the existence of alterations", the collecting and comparing of known information in Classen, the comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC, as well as Mayo.
Claim 2 recites “determining the loss of mass from the surface”, however this is directed to the abstract idea (mental process) as indicated above. In particular, this limitation further narrows the abstract idea (the determining step involves determining the change, the change represents loss of mass).
See similarly claim 8, further reciting limitations directed at determining the expected mass, determining the number of particles of the expected mass or contrast release, and optionally comparing the results to a standard or calibration curve. As discussed above, comparing results to a standard/calibration curve (a comparison to reference data) is considered to be a judicial exception as this type of limitation is categorized as an abstract idea.
Regarding independent claim 10, in addition to the abstract idea limitations as noted above for claim 1 (the same abstract idea limitation is also recited at claim 10, see “determining the change in light scattering”), see also the claim is directed to laws of nature/natural phenomena. The claim recites that the method is “a method of diagnosing a disease or condition associated with the presence or amount of a biomarker”, the claim recites “wherein the presence or absence of i) or ii) is indicative of the presence, severity, or likelihood of developing the disease or condition”.
The claim is directed to the natural relationship between an undefined biomarker (see the claim not limited to any particular species, and broadly encompasses any disease associated biomarker) and an undefined disease/condition. The natural relationship to which the claims are directed is a law of nature. Similar concepts have been held by the courts to constitute law of nature/ natural phenomena, as in the identification of a correlation between the presence of a biomarker in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017). In Mayo, the Supreme Court found that a claim was directed to a natural law, where the claim required administering a drug and determining the levels of a metabolite following administration, where the level of metabolite was indicative of a need to increase or decrease the dosage of the drug. See Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66, 74 (2012).
The present claims are similar to those in Mayo as they involve "relation itself [which] exists in principle apart from any human action" (id. at 77), namely the relationship between the naturally occurring biomarker and the presence, severity or likelihood of a disease/condition. The correlation between the biomarker and the disease/condition is a judicial exception as it exists in principle apart of any human interaction; the correlation itself therefore cannot form the basis for eligibility.
Further, claim 14 is directed to abstract ideas, namely mental processes. The claim recites “selecting a subject to whom a substance or composition is to be administered, or to whom a treatment or dosage regimen is to be prescribed”, the claims encompass activity performed in the human mind, namely observing the results and forming an observation, evaluation or judgment.
Step 2A, Prong 2
The above discussed limitations are themselves insufficient to integrate the judicial exceptions into a practical application because those limitations themselves represent the judicial exceptions (not an application thereof).
Regarding claim 1, in addition to the judicial exception, the claim recites active method steps for performing the binding/the assay itself (see steps I through V, the detecting released particles). However, the additionally recited assay method steps referenced are considered to be extra-solution activity, these steps are performed in order to gather/obtain the data. These limitations are performed in order to obtain the data which is used in the comparison to observe the change. None of these steps practically apply the judicial exception because none of these steps/elements apply, rely on or using the judicial exception in a sufficiently meaningful way required under 2A, Prong 2. This is similarly the case regarding remaining dependent claim limitations which depend from claim 1. For example, referring to claim 4, e.g., application of release reagent, claim 7, regarding the detection area (passivated, activated, coated, treated or derivatized), claim 9, repeating steps of claim 1, claim 12 providing components necessary for the gathering of the data/for performing the assay, claim 13 incubation in order to allow binding, claims 17 and 18 as well as claims 20-22, directed to limitations which further narrow the limitation to the type of biomarker/capture agent. None of the additional recited limitations (recited in addition to the judicial exception(s) themselves, apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
This is similarly the case at claim 10, the claim encompasses the same steps/elements for obtaining the data used in the abstract idea and natural correlation.
Regarding claim 14, there is no additional step, for example, of using the judicial exception(s) to effect a particular treatment or prophylaxis for a disease or medical condition.
Additionally, while claim 15 does recite “a method of treating or preventing a disease or condition in a subject diagnosed with a disease or condition or likelihood of developing said disease or condition… the method comprises administering a substance or composition to the subject, or carrying out a regimen thereon, which is effective to treat or prevent said disease or condition in the subject”, these limitations are also not sufficient limitations, as they do not amount to a particular treatment or prophylaxis for a disease or medical condition. As noted previously, these limitations are not limited in terms of a particular disease/condition or treatment. When evaluating limitations specific to treatment/prophylaxis, it is necessary to consider the particularity or generality of the treatment or prophylaxis limitations, whether the limitations have more than a nominal or insignificant relationship to the exceptions, and whether the limitations are merely extra-solution activity or field of use. In the present case, the treatment limitations recited at claim 15 do not meet the requirements set forth by the relevant considerations for treatment limitations. The recited administration limitations are not particular, and instead merely encompass instructions to “apply” the exception in a generic way.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Additionally, the remaining elements/limitations recited by the claims in addition to the judicial exceptions do not add significantly more to the judicial exceptions. In particular, the assay method steps performed in order to obtain the change in scattering amount to insignificant presolution activity, steps performed in order to gather the data.
In addition, such steps/elements were considered to be routine and conventional in the assay art relevant to observing light scattering/interferometric measurements, see which is as supported by Prober et al., WO2004/044232A1 (IDS entered 03/21/2023). Prober, as cited in detail below, is teaching methods consistent with the present claims (Prober published prior to the effective filing date of the claimed invention, see specifically 2004). Prober et al. teach a method for detecting a biomarker (analyte) in a sample using single molecule interferometric light scattering (see page 13, e.g., lines 15-37), the method comprising providing in solution a surface (particle surface) comprising a capture agent immobilized on the surface, wherein the capture agent is capable of binding to the biomarker present in the sample, contacting the surface with the sample to allow binding to the capture agent, defining a first detection area (the area with the capture agent), taking a measurement of the surface using a light scattering, the method further comprising releasing the particle bound to the surface (the particle being the analyte/biomarker, see page 13, dissociating at least the analyte from the capture probe), detecting the particle released from the detection area (capture agent) by determining the light scattering at the surface (see page 13, detecting dissociation by comparing the differences between the resonant light scattering signatures).
See also at page 62, lines 12-33 Prober et al. teach dissociation using means known in the art, including temperature, or treatment with an acid or base or chaotropic agent (i.e., release reagent applied). Prober et al. is also teaching a detection area (the area containing the capture agent, i.e., particle surface) is activated/treated for conjugation with the capture agent (see e.g., end of page 38-40, see page 40 up to line 17).
It does not appear to be the case that the active steps recited, alone or as an ordered combination, amount to more than that which well known in the assay art before the effective filing date of the claimed invention. For the reasons as indicated above, the claims fail to include additional elements/steps that are sufficient to either integrate the judicial exception into a practical application thereof, or amount to significantly more than the judicial exceptions themselves.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 7, 10, 12-14, 17-18 and 22 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Prober et al., WO2004/044232A1.
Prober et al. teach a method for detecting a biomarker (analyte) in a sample using single molecule interferometric light scattering (see page 13, e.g., lines 15-37), the method comprising providing in solution a surface (particle surface) comprising a capture agent immobilized on the surface, wherein the capture agent is capable of binding to the biomarker present in the sample, contacting the surface with the sample to allow binding to the capture agent, defining a first detection area (the area with the capture agent), taking a measurement of the surface using a light scattering, the method further comprising releasing the particle bound to the surface (the particle being the analyte/biomarker, see page 13, dissociating at least the analyte from the capture probe), detecting the particle released from the detection area (capture agent) by determining the light scattering at the surface (see page 13, detecting dissociation by comparing the differences between the resonant light scattering signatures).
Regarding claim 2, the determination of the difference between the signals is a determination of the mass change (loss of mass at the surface as a result of the dissociation), see page 61-62, particularly at lines 19-28.
Regarding claim 4, the dissociation, see page 62, lines 12-33 Prober et al. teach dissociation using means known in the art, including temperature, or treatment with an acid or base or chaotropic agent (i.e., release reagent applied).
Regarding claim 7, Prober et al. is teaching a detection area (the area containing the capture agent, i.e., particle surface) is activated/treated for conjugation with the capture agent (see e.g., end of page 38-40, see page 40 up to line 17).
Regarding claim 10, see as cited in detail above, Prober teach a method comprising the steps as claimed (claim 10 reciting same steps as claim 1), Prober further teaching their methods applicable for disease diagnosis (page 45, line 17, to page 46, line 22; see also page54, lines 17-20). As such, the invention of Prober et al. addresses presence indicative of presence of disease.
Regarding claim 12, see as cited above, Prober’s methods comprise providing a surface (e.g., particles, however, see even further Prober et al. pages end of 33 to 34, line 10, encompasses also surfaces comprising two dimensional formats), providing a sample to be analyzed for presence/amount of particle, immobilizing on the surface capture agent specific for the target/biomarker (see as cited above).
Regarding claim 13, see also Prober et al. teach their assay methods may comprising additional steps such as incubations (page 46, line 27), see also at examples, Prober describe at the contacting step, incubating for suitable time and under suitable conditions to allow binding (page 79, step D).
Regarding claim 14, see also Prober teach application including screening for drug candidates (which is considered to address selecting a subject to be administered/receive a treatment).
Regarding claim 17, Prober et al. teach analytes that are proteins, peptides, nucleic acid, etc. (see e.g., page 20, liens 26-32).
Regarding claim 18, Prober et al. teach capture agent such as antibody, or protein, etc., see page 21, lines 19-27.
Regarding claim 22, see further Prober’s method encompass detecting analytes inclusive of bacteriophage or virus, as such the method encompass detecting contamination of sample (i.e., due to bacterial or viral infection, for example).
Claim(s) 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cornillie et al., Ten years of infliximab (Remicade) in clinical practice: The story from the bench to the bedside, European Journal of Pharmacology, 623, Supplemental 1, (2009), 4 pages.
Claim 16 is directed to a product, namely “a substance or composition for use in a method of treating or preventing disease or condition in a subject diagnosed with a disease or condition or likelihood of developing said disease or condition in the subject according to claim 10”. Any substance or composition capable of being used to treat a disease or condition detectable by the method of claim 10 (which claim 10 is unlimited with regard to any particular disease/condition or biomarker), i.e., any known treatment known in the prior art for any biomarker diagnosable disease/condition, known before the effective filing date, would read on the claimed invention. For example, see Cornillie et al., teaching infliximab (abstract, first introduced in 1999 to treat Crohn’s disease), antibody that binds and blocks TNF.
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.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Prober et al.
Prober et al. teaches a method substantially as claimed (see above), however fails to teach further comprising repeating steps IV) and V) for a second or further detection area of the surface.
However, Prober et al. does suggest their method applied for multiplex detection, see for example end of page 33 to 34, Prober describe using a multiplicity of particles, the microparticles distributed in a two-dimensional format, identifying individual particles according to a pattern, identities established by position, for example (see page 34, line 4).
It would have been obvious, when identifying based on position in a two dimensional format, that the assay steps be repeated for a second/the additional position (i.e., repeating the same steps, but for additional microparticles as described in Prober. It would have been obvious that the steps be repeated for the additionally positioned microparticles in order to obtain result for those additional particles. One having ordinary skill in the art having a reasonable expectation of success because Prober support this format as an ability of their invention.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Prober et al. in view of Fung et al., US PG Pub No. 2008/0274481A1.
Regarding claim 15, although Prober et al. teach their methods for applications including diagnostic assays and screening drug candidates (referring to citations above), Prober et al. does not teach a step comprising administering a substance or composition which is effective to treat or prevent disease.
Fung et al. is an example of using a biomarker for determining a patient’s therapy, see specifically (para [0015]), Fung et al. teach methods comprising detecting biomarkers and correlating the measurements with ovarian cancer status, the methods further comprise managing subject treatment based on the status. Specifically, if the measurement correlates with ovarian cancer, administering a chemotherapeutic agent to the subject (para [0015]). See at para [0002], ovarian cancer is among the most lethal gynecologic malignancies, having a mortality rate that has remained virtually unchanged over two decades, the prior art recognizing the importance of early detection for long-term survival.
It would have been prima facie obvious to one having ordinary skill before the effective filing date of the claimed invention to have modified the method of Prober et al. in order to detect markers that correlate with ovarian cancer, namely to determine and subsequently treat those subjects with ovarian cancer with a chemotherapeutic agent, one motivated to do so because ovarian cancer is recognized as being among the most lethal gynecologic malignancies, having a mortality rate that is remained virtually unchanged over two decades, the prior art recognizing the importance of early detection for long-term survival. One would have been motivated to detect and further treat said subject in order to improve their outcome (survival). One having ordinary skill in the art would have a reasonable expectation of success because Prober’s method is taught as broadly applicable for diagnostic assay (see as cited previously above), and because Fung et al. is evidence that supports detecting ovarian cancer related biomarkers is known to the art, and because treatments for this type of cancer are known (chemotherapy).
Claim(s) 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Prober et al., in view of Luciw et al., US PG Pub No. 2004/0229284A1.
Regarding claim 20, Prober et al. teach a method substantially as claimed, detecting targeted analytes (see as cited above). However, Prober et al. fail to teach their assay methods applied in order to detect a biomarker indicative of the presence of the modified biological molecule.
Luciw et al. teach methods for multiplexed detection of one or more posttranslational modification of a plurality of protein (detecting biomarker indicative of modified molecule) for the purposes of diagnosis, prognosis and monitoring of disease (see abstract and para [0006] and [0008]). See at para [0004], aberrant modification of cellular proteins (e.g., aberrant glycosylation or phosphorylation) is a feature of many diseases
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Prober et al. in order to apply their method for the detection of post-translationally modified proteins (i.e., modified biological molecules) in order to diagnose diseases related to aberrant modification (Luciw et al.). One having ordinary skill in the art would have a reasonable expectation of success because Prober’s method is taught as broadly applicable for diagnostic assay (see as cited previously above).
Regarding claim 21, a post translationally modified protein is indicative of interaction of that protein with another molecule (indicative of interaction between molecules).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Prober et al. in view of Zuk et al., US 4,256,834 Callister et al., US PG Pub No. 2010/0184086A1 and Fischer et al., US PG Pub No. 2009/0233309A1.
Prober et al. is teaching assay components that include a surface, a capture reagent (see as cited in detail above). Further Prober et al. teach determining the amount of analyte in a sample from a calibration curve prepared using known standards (page 59, lines 29-31, i.e., standards for calibration). Prober et al. also teach their assays comprising steps including washings, miscellaneous reagents, etc. (see page 46, lines 26-28, see for example, steps including a wash buffer, page 73, line 36, further washed using PBS buffer, page 80, line 35).
However, Prober fails to teach a sample collection device, and fails to teach the components necessary for the assay provided in kit form with instructions for use in accordance with the method as in claim 1.
However, Zuk et al. teach that in performing assays, it is convenient and to combine the necessary reagents together in a kit (column 22, lines 20-68 in particular). Zuk et al. further teach that this may improve assay accuracy.
See for example, Callister at paras [0030]-[0032] teaching kits for diagnostic detection of a targeted biomarker. At para [0031] Callister teach providing reagents for an assay and instructions for performing an assay (using the reagents) in kit form provides convenience. See at para [0032] Callister teach kits conveniently providing carrier immobilized reagent, detection reagent, use instructions, etc.
Further, see for example Fischer et al., para [0086], Fischer teach providing as part of an assay kit collection devices for sample or specimen collection (collection devices and collection vessels to collect samples).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have provided the assay components (namely, the surface, capture agent, buffer), of Prober et al., including instructions for performing methods intended by the kit, as in Callister et al., together in kit form for convenience and accuracy as taught by Zuk et al. and Callister et al. Further one having ordinary skill in the art would have been motivated to have included as part of the kit a collection device, as in Fischer et al., in order to facilitate a way to collect the sample for the method.
One having ordinary skill in the art would have had a reasonable expectation of success because the modification, to provide the components in kit form, would be considered an improvement (in terms of convenience and accuracy), and as such there would be no expectation that providing in the form of a kit would in any way interfere or obstruct the intent of the assay.
Additionally, regarding the limitations directed to instructions for use of the kit (in accordance with the method of claim 1), see MPEP 2111.05, regarding functional and non-functional descriptive material. Referring to MPEP 2111.05, “For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.” Nonetheless, see as noted above, based on the prior art as cited above, when providing the components for assay as part of a kit, it would have been obvious to have included instructions for performing the method intended for that kit.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
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