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
Applicant’s claim for priority to a provisional application 62/644,467 is acknowledged. The effective filing date for claims 1-2, 5, 7, 9, 12, 15 and 17-22 is 3/17/2018.
Status of the Claims
In the response filed March 10, 2025, Applicant has amended claims 1 and 22, and canceled claims 10-11, 13-14, 16, and 23-66, and filed new claims 67-70.
Claims 3-4, 6, and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of metal particles, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jan. 9, 2024.
Currently, claims 1-2, 5, 7, 9, 12, 15, 17-22, and 67-70 are under examination.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The rejection of claims 1 and 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jean Burckhardt (Patent Number: 5,501,963; published Mar. 26, 1996, hereinafter as Burkhardt) is withdrawn because Burckhardt is silent regarding wherein the assay substance binds to at least one molecular component by non-specific interactions.
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, 5, 7, 9, 12, 15, and 17-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This rejection is repeated with regard to claims 1, 2, 5, 7, 9, 12, 15, and 17-22 for the same reasons of record as set forth in the Official action mailed on Dec. 10, 2024. A response to applicant' s traversal follows the reiterated rejection below.
Claim 1 recites “a method of evaluating function, status and/or activity of an immune system of a subject, the method comprising; mixing an assay substance with a blood or blood component from the subject to form an assay product that comprises at least one unit of the assay substance and at least one molecular component of the blood or blood component; analyzing the assay product under conditions to determine an assay product property, the assay product property comprising a physical, chemical, optical, electrical, magnetic, and/or mechanical property; and comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value, wherein the comparative data value indicates the function, status and/or activity of an immune system of the subject.”
Per the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 7, 2019 (84 Fed. Reg. 50), if a claim recites a limitation that can practically be performed in the human mind, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. Claims recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.
The courts consider a mental process (thinking i.e. comparing) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work' that are open to all.' " 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work' " (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
Regarding claim 1, the “comparing” step is considered to embrace a mental process. See also MPEP 2106.04(a-b).
Step 1-Statutory Category: According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter). Claim 1 is drawn to a method for evaluating function, status and/or activity of an immune system of a subject. Thus, the process meets the requirements for step 1 of the analysis as it is drawn to a method.
Next the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019 PEG, “directed to" is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application", requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 210 6.05 for examples of integration of practical application).
Step 2A Judicial Exception-Prong 1 (claim is directed to a judicial exception): Prong 2A asks whether the claim recites an abstract idea, law of nature, or natural phenomenon (product of nature).
Regarding claim 1, recites a judicial exception in the step of “comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value, wherein the comparative data value indicates the function, status and/or activity of an immune system of the subject”, which requires a mental step. The claim 1, “comparing” step of comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value is an abstract idea involving mental processes because a simple comparison of the data values obtained can be performed mentally. Claims can recite a mental process even if they are described in the specification and/or claimed as being performed on a device. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 2, dependent on claim 1, recites “wherein the at least one unit of the assay substance comprises at least one metal particle.” Claim 2 just describes the assay substance. Therefore, claim 2 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 5, dependent on claim 1, recites “wherein the assay substance comprises a surface of a material which is able to interact with one component of a blood through specific or nonspecific interaction”. Claim 5 just describes the assay substance. Therefore, claim 5 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 7, dependent on claim 1, recites “wherein the assay substance is a gold nanoparticle”. Claim 7 just describes the assay substance. Therefore, claim 7 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 9, dependent on claim 1, recites “wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product”. Claim 9 just describes the analyzing step. Therefore, claim 9 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 12, dependent on claim 1, recites “wherein the unexposed assay substance comprises at least one metal particle”. Claim 12 just describes the unexposed assay substance. Therefore, claim 12 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 15, dependent on claim 1, recites “wherein the at least one molecule component comprises an antibody or complement protein, or combination thereof”. Claim 15 just describes the molecule component. Therefore, claim 15 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 17, dependent on claim 1, recites “further comprising obtaining an average control data value or range of control data values from a population having a known immune system function, status and/or activity; and wherein when the comparative data value deviates from the average control data value or range of control data values indicates a higher or lower immune function, status and/or activity in the subject”. Claim 17 just describes the average control data value or range of control data values from a population. Therefore, claim 17 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 18, dependent on claim 1, recites “wherein when the comparative data value is lower than the average control data value or range of control data values indicates a decrease in immune function”. Claim 18 just describes the comparative data values. Therefore, claim 18 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 19, dependent on claim 1, recites “wherein the known immune system function, status and/or activity comprises a population known to have a healthy immune function, status and/or activity; and wherein when the comparative data value is higher than the average control data value or range of control data values indicates an elevated immune response”. Claim 19 just describes the comparative data values. Therefore, claim 19 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 20, dependent on claim 1, recites “wherein the elevated immune response is a result of an infection”. Claim 20 just describes the elevated immune response. Therefore, claim 20 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 21, dependent on claim 1, recites “wherein the function, status, and activity of the immune system indicates a health condition of the subject”. Claim 21 just describes the health condition of the subject. Therefore, claim 21 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 22, dependent on claim 1, recites “wherein the health condition comprises detection and/or diagnosis of diseases that involve an immune response”. Claim 22 just describes the health condition. Therefore, claim 22 does not remedy the deficiency of claim 1. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Furthermore, there is nothing about claims 1, 2, 5, 7, 9, 12, 15, and 17-22 that include additional elements that are sufficient to amount to significantly more than the judicial exception since the invention as claimed does not introduce or recite any step of compositions that is beyond that which is well understood, routine and conventional.
Step 2A Judicial Exception-Prong 2 (Judicial exception is integrated into a practical application): The phrase, "integration of a practical application", requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful Iimitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application). Prong 2 asks whether a claim recites additional elements that integrate the judicial exception into a practical application.
In claim 1, there is no step after the step of “comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value, wherein the comparative data value indicates the function, status and/or activity of an immune system of the subject”, there is no additional steps requiring a practical application (e.g. applying a treatment, action, or substance). The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 2, dependent on claim 1, recites “wherein the at least one unit of the assay substance comprises at least one metal particle.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 5, dependent on claim 1, recites “wherein the assay substance comprises a surface of a material which is able to interact with one component of a blood through specific or nonspecific interaction”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 7, dependent on claim 1, recites “wherein the assay substance is a gold nanoparticle”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 9, dependent on claim 1, recites “wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 12, dependent on claim 1, recites “wherein the unexposed assay substance comprises at least one metal particle”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 15, dependent on claim 1, recites “wherein the at least one molecule component comprises an antibody or complement protein, or combination thereof”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 17, dependent on claim 1, recites “further comprising obtaining an average control data value or range of control data values from a population having a known immune system function, status and/or activity; and wherein when the comparative data value deviates from the average control data value or range of control data values indicates a higher or lower immune function, status and/or activity in the subject”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 18, dependent on claim 1, recites “wherein when the comparative data value is lower than the average control data value or range of control data values indicates a decrease in immune function”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 19, dependent on claim 1, recites “wherein the known immune system function, status and/or activity comprises a population known to have a healthy immune function, status and/or activity; and wherein when the comparative data value is higher than the average control data value or range of control data values indicates an elevated immune response”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 20, dependent on claim 1, recites “wherein the elevated immune response is a result of an infection”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 21, dependent on claim 1, recites “wherein the function, status, and activity of the immune system indicates a health condition of the subject”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 22, dependent on claim 1, recites “wherein the health condition comprises detection and/or diagnosis of diseases that involve an immune response”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Thus, claims 1, 2, 5, 7, 9, 12, 15, and 17-22 meet the requirements of step 2A as being directed to a judicial exception.
Step 2B Significantly More: The "significantly more" analysis determines that a claim is patent eligible if the claims recite structures or functions that transform the natural product in a manner that make the product markedly different from the judicial exception. The nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state.
Claim 1 does not add significantly more than the judicial exception. The claim recites “comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value, wherein the comparative data value indicates the function, status and/or activity of an immune system of the subject.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Claim 2, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the at least one unit of the assay substance comprises at least one metal particle.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 5, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the assay substance comprises a surface of a material which is able to interact with one component of a blood through specific or nonspecific interaction”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 7, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the assay substance is a gold nanoparticle”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 9, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 12, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the unexposed assay substance comprises at least one metal particle”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 15, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the at least one molecule component comprises an antibody or complement protein, or combination thereof”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 17, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “further comprising obtaining an average control data value or range of control data values from a population having a known immune system function, status and/or activity; and wherein when the comparative data value deviates from the average control data value or range of control data values indicates a higher or lower immune function, status and/or activity in the subject”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 18, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein when the comparative data value is lower than the average control data value or range of control data values indicates a decrease in immune function”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 19, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the known immune system function, status and/or activity comprises a population known to have a healthy immune function, status and/or activity; and wherein when the comparative data value is higher than the average control data value or range of control data values indicates an elevated immune response”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 20, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the elevated immune response is a result of an infection”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 21, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the function, status, and activity of the immune system indicates a health condition of the subject”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 22, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the health condition comprises detection and/or diagnosis of diseases that involve an immune response”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 1 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
It is well established that data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant activity (see also MPEP 2106.05(g)).
Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. (see MPEP 2106.04(a)(2)(III).)
In conclusion, claims 1, 2, 5, 7, 9, 12, 15, and 17-22 recites abstract ideas which are not considered to disclose eligible subject matter under 35 U.S.C. 101, and therefore are deemed not patent eligible.
Response to Traversal:
Applicant asserts that “the assay substance lacking specific interaction with a molecular component” is not natural, and thus is patent eligible under prong 2B (Remarks, page 6-7). Applicant asserts that claim 1 has been amended to clarify that “the assay substance is one that binds to the molecular component by non-specific interactions and that an assay substance that lacks specific interactions with at least one molecular component is a unique, unconventional substance that is not natural” (Remarks, page 6). Further, Applicant argues that “claim 1 recites a mixing step that mixes a natural substance with an unconventional non-natural substance to form a non-natural assay product, and then a step that involves subjecting the non-natural assay product to techniques to determine an assay product property of the non-natural assay product” (Remarks, page 7).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
Applicants’ arguments regarding the assay substance lacking specific interactions (i.e. non-specific interaction) are not natural is acknowledged. However, this argument is deemed unpersuasive since the 101 rejection was made due to an abstract idea in Prong 2A and the claim not reciting an additional element that amounts to significantly more than the judicial expectation in prong 2B (see the "significantly more" analysis above and the comparing step in claim 1, line 10). In response, to Applicants argument that the claim incorporates a non-natural substance to form a non-natural assay product under prong 2B, the claim incorporates an abstract step and requires a mental step (i.e. comparing). The 101 rejection is direct to the claim reciting the step of comparing an assay product property with a correlative property which recites mental steps (see e.g. claim limitations “analyzing” and “comparing”) that are not integration of a practical application. Thus, the 101 rejection is still maintained due to the claim reciting the last step is a “comparing” step that reads on a mental step.
As stated above, although the mixing step involves subjecting the non-natural assay product to techniques to determine an assay product property of the non-natural assay product, claim 1 has no step after the step of “comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value, wherein the comparative data value indicates the function, status and/or activity of an immune system of the subject”, there is no additional steps requiring a practical application (e.g. applying a treatment, action, or substance).
Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception MPEP § 2106.05(g) and are generic computing components merely carrying out the abstract idea - see MPEP § 2106.0S(f) and (b)). Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception and do not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements, as discussed above.
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)(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.
Claims 1-2, 5, 7, 9, 12, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huo (US20130052661A1 App. No. 13/522,391, published 2013).
This rejection is repeated with regard to claims 1, 2, 5, 7, 9, 12, and 15 for the same reasons of record as set forth in the Official action mailed on Dec. 10, 2024. A response to applicant' s traversal follows the reiterated rejection below.
Regarding Claim 1, Huo teaches a method of evaluating function, status and/or activity of an immune system of a subject (para. 21). Hou discloses non-specific nanoparticle-enabled dynamic light scattering assay (NanoDLSay™) for biomolecule detection and analysis (see e.g. Fig. 1). Further, Huo discloses that the binding of proteins to the gold nanoparticles (AuNP) is through non-specific interactions (e.g. non-specific adsorption interactions such as electrostatic interactions, Au—N, and Au—S bonding)(see e.g. para. 9-11, fig. 1-2), which will lead to the formation of a protein corona on the nanoparticle surface, or nanoparticle clusters (see e.g. para. 9-11, Fig. 1-2) corresponding to the claim limitation wherein the assay substance binds to at least one molecular component of the blood or blood component is by non-specific interactions.
In regard to the mixing step, Huo teaches mixing an assay substance with a blood or blood component from the subject to form an assay product (see e.g. para. 21). Further, Huo teaches that comprises at least one unit of the assay substance and at least one molecular component of the blood or blood component (para. 33).
In regard to the analyzing step, Huo teaches analyzing the assay product under conditions to determine an assay product property, the assay product property comprising a chemical property (para. 24).
In regard to the comparing step, Huo teaches comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value, wherein the comparative data value indicates the function, status and/or activity of an immune system of the subject (abstract, para. 15, 37 and Fig. 6).
Regarding Claim 2, Huo teaches wherein the at least one unit of the assay substance comprises at least one metal particle (i.e. Au)(para. 33).
Regarding Claim 5, Huo teaches wherein the assay substance comprises a surface of a material which is able to interact with one component of a blood through specific or nonspecific interaction (paras. 9-11, Fig. 1-2).
Regarding Claim 7, Huo teaches wherein the assay substance is a gold nanoparticle (para. 9-11, 33; Fig. 1-2).
Regarding Claim 9, Huo teaches wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product (para. 9, Fig. 1).
Regarding Claim 12, Huo teaches wherein the unexposed assay substance comprises at least one metal particle (para. 9-11, 33; Fig. 1-1).
Regarding Claim 15, Huo teaches wherein the at least one molecule component comprises an antibody (para. 7-11, Fig. 1-2, 4).
Accordingly, Huo anticipates the instant claims.
Response to Traversal:
Applicant argues that Hou is “silent concerning mixing blood or blood component with an assay substance, wherein at least one molecular component binds to the assay substance by non-specific interactions" (Remarks, page 7-8). Applicant asserts that Hou “focuses on mixing probes that specific bind to certain molecule of interest in a biological sample” (Remarks, page 8).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to Applicant argument, Hou discloses detecting biomolecules in a biological sample (i.e. serum) with an assay substance (i.e. AuNPs to make a metal nanoparticle or immunoprobe)( see e.g. para. 21,33, Examples 3-4) and through non-specific interactions or adsorption of biomolecules to the AuNPs (see para. 10, Fig. 1). Contrary to Applicants assertion, Hou discloses the binding of proteins to the gold nanoparticles (AuNP) through non-specific interactions (see e.g. para. 10, fig. 1).
In response to Applicant argument that Hou focuses on mixing probes with specific binding, contrary to Applicants assertion Hou discloses a AuNP probe solution that discloses non-specific binding (i.e. non-specific adsorption interactions such as electrostatic interactions, Au—N, and Au—S bonding )(see e.g. fig. 1, para. 10). As discussed above, Huo discloses that the assay substance comprises a surface of a material which is able to interact with one component of a blood through nonspecific interaction (para. 9 and 33, Fig. 1-6). Further, the breadth of the claims reciting mixing an “assay substance”, which is very broad, and reads on the AuNPs immunoprobes (i.e., metal nanoparticles). Furthermore, the Specification asserts that the term "non-specific interaction" is the adsorption process of a layer of proteins from blood to the surface of a citrate ligand capped gold nanoparticle is often called non-specific interaction, or non-specific adsorption (Specification para. 48, page 9).
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.
Claim 1-2, 5, 7, 9, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al (US 2007/0238102 A1; published Oct. 11, 2007), in view of Schramm, Elizabeth C., et al. ("A quantitative lateral flow assay to detect complement activation in blood." Analytical biochemistry 477 (2015): 78-85, published 2015; hereinafter as Schramm et al) and “Tech Tip #65 ELISA technical guide and protocols" (Thermo Scientific Manual 747: 815; published 2010, hereinafter as “Thermo”).
This rejection is repeated with regard to claims 1, 2, 5, 7, 9, 12, and 15 for the same reasons of record as set forth in the Official action mailed on Dec. 10, 2024. A response to applicant' s traversal follows the reiterated rejection below.
Regarding Claim 1, Song et al teaches a method of evaluating function, status and/or activity of an immune system of a subject (para. 1).
In regard to the mixing step, Song teaches mixing an assay substance with a blood or blood component from the subject to form an assay product (para. 16, 29). Song discloses substrate (i.e. blood component)(e.g. para. 22) include a substrate conjugates that are joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter (i.e. assay substrate)(see e.g. para. 35). Further, Song discloses that “it should also be understood that, besides covalent bonding, other attachment techniques, such as physical adsorption, may also be utilized in the present invention.” (see e.g. para. 35). The specification recites that when non-specific interaction is involved between a substance and a molecular unit, it can be also called as a physical adsorption process (see para. 48). Therefore, the substrates (i.e. molecular blood component) non-specific interaction (i.e. adsorption process) to a reporter (i.e. assay product) as taught by Song reads on the claim limitation of non-specific interactions.
In regard to the unit of assay substance, Song teaches a biological sample comprising an enzyme to a biological substance such as a substrate (i.e. blood component)(e.g. para. 22) to produce a product conjugated with a label (i.e. reporter), and analyzing the labeled product (see e.g. para. 62 and 65) corresponding to the claim limitation that the method comprises at least one unit of the assay substance and at least one molecular component of the blood or blood component.
In regard to the analyzing step, Song teaches analyzing the assay product under an immunoassay or fluorescence spectroscopy (para. 62-63).
In regard to the comparing step, Song teaches comparative data value wherein detecting normal versus abnormal enzyme concentrations may also indicate other conditions, such as a bacterial, viral infection or cancer (para. 1), corresponding to the claim limitation of indicating the status of an immune system of the subject.
Regarding Claim 1, Song is silent regarding the comparing the assay product property with a correlative property of an unexposed assay substance to generate a comparative data value.
However, Thermo teaches that it is important to balance the amount of enzyme giving specific signal versus that giving background signal and this is best controlled by optimizing the enzyme conjugate, antibodies and blocking solution. It is also important to note that optimal conditions for one antigen may not be optimal for another” (page 7, last para.)
Regarding Claim 1, Thermo teaches performing an ELISA one of ordinary skill in the art would use a blocking buffer, which “usually consist of formulations of proteins designed to prevent non-specific binding of proteins to the plate. An optimal blocking buffer maximizes the signal-to-noise ratio and does not react with the antibodies or target protein” (page 6, part C).
Accordingly, it would have been obvious to modify the method of Song et al and prepare a negative control as taught by Thermo et al because Thermo teaches that it is important to balance the amount of enzyme that is giving specific signal versus that giving background signal in order to obtain the optimal results (page 6, part C). Furthermore, a person of ordinary skill in the art would have been motivated to perform a negative control of an unexposed assay substance in order to generate a comparative data value as taught in the ELISA protocol of Thermo et al because it would have been important to account for a high background signal (page 7, last para.). Thus, it could have been done with a reasonable expectation of success.
Regarding Claim 2, Song teaches teaching using reporter or labels such as metallic particles, i.e. gold (see [0023]), corresponding to the claim limitation wherein at least one unit of the assay substance comprises at least one metal particle.
Regarding Claim 5, Song wherein the assay substance comprises a surface of a material which is able to interact with one component of a blood through specific or nonspecific interaction.
Regarding Claim 7, Song wherein the assay substance is a gold nanoparticle (para. 34).
Regarding Claim 9, Song wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product.
Regarding Claim 12, Song is silent wherein the unexposed assay substance comprises at least one metal particle.
However, the prior art of Schramm discloses a quantitative lateral flow assay to detect complement activation in blood (See e.g. title and abstract).
Regarding Claim 12, Schramm teaches immobilized capture antibody forms a test line on the exposed nitrocellulose by capturing the antigen–antibody–gold complex in a concentration- and time-dependent manner (see assay principle). Further, Schramm teaches a test-line and a control line is composed of anti-IgG (immunoglobulin G) antibodies and captures any gold-conjugated antibodies (Fig. 2, legend), corresponding to the claim limitation wherein the unexposed assay substance comprises at least one metal particle.
Accordingly, it would have been obvious to modify the method of Song and prepare a negative control as taught by Thermo and Schramm with a reasonable expectation of success. A person of ordinary skill would have been motivated to do so for several reasons. First, Thermo et al teaches that important to balance the amount of enzyme giving specific signal versus that giving background signal. Secondly, Schramm teaches a “control line is composed of anti-IgG (immunoglobulin G) antibodies and captures any gold-conjugated antibodies, thereby demonstrating that the reaction conditions and technology worked (see lateral flow assay section). Thus, a person of ordinary skill in the art would have performed a negative control of an unexposed assay substance with the metal particle to generate a comparative data value and account for a high background signal to prove that the technology did not have false positive results or unwanted interactions.
Regarding Claim 15, Song wherein the at least one molecule component comprises an antibody or complement protein, or combination thereof (para. 70).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant asserts that “Song fails to teach the formation of an assay product that involves mixing a molecular component from blood or blood component with an assay substance that binds to the molecular component by non-specific interactions” (Remarks, page 8-9). Further, Applicant argues that “Song teaches the opposite, specific binding of any enzyme to its substrate” (Remarks, page 9).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
Contrary to Applicants assertion, Song discloses substrates (i.e. blood component)(e.g. para. 22) include a substrate conjugates that are joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter (i.e. assay substrate)(see e.g. para. 35) and form an assay product, as discussed above. Further, Song teaches mixing an assay substance with a blood or blood component from the subject to form an assay product (see e.g. para. 16, 29).
In response to Applicants argument regarding Song failing to teach non-specific interactions, Song discloses a substrate and/or conjugates (i.e. molecular component)(e.g. para. 22) that include non-specific interactions that are joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter (i.e. assay substrate) (See e.g. abstract, para. 35). Further, Song discloses that “it should also be understood that, besides covalent bonding, other attachment techniques, such as physical adsorption, may also be utilized in the present invention.” (see e.g. para. 35). Contrary to the Applicants assertion, the specification recites that when non-specific interaction is involved between a substance and a molecular unit, it can be also called as a physical adsorption process (see para. 48). Therefore, the physical adsorption interaction as taught by Song reads on the claimed non-specific interaction, as discussed above.
In response to Applicants argument regarding Song teaching away from non-specific interactions (i.e. specific binding of any enzyme to its substrate). Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Therefore, lack of evidence to the contrary, a person of ordinary skill in the art would understand that a blood sample would comprise a molecular component like enzymes. Furthermore, Applicant does not recite where Song teaches away.
Further, Applicant argues that “the cited Schramm and Tech Tip references do not modify the teachings of the primary Song reference because Schramm is limited to teachings of quantitative lateral flow assays that involve specific binding of lgG antibodies by anti-lgG antibodies” (Remarks, page 9).
In response to Applicants arguments regarding Schramm and Tech Tip, the references are cited for teaching the importance of balance in an assay substance and the amount of enzyme giving specific signal versus that giving background signal, as discussed above. Accordingly, a person of ordinary skill in the art would have performed a negative control of an unexposed assay substance with the metal particle to generate a comparative data value and account for a high background signal to prove that the technology did not have false positive results or unwanted interactions, as discussed above. Therefore, a person of ordinary skill in the art would have had a reasonable expectation of success because both Song, Schramm and Tech Tip disclose detection methods with antibodies. Furthermore, an artisan of ordinary skill in the art of (i.e. detection techniques) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claims 17-22 and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Huo (US20130052661A1 App. No. 13/522,391, published 2013, prior art of record) in view of as applied to Claim 1-2, 5, 7, 9, and 12-15, in further view of Casabianca, Anna, et al. (PLoS One 9.11: e111919., published 2014, prior art of record) and Liu, Xiong, et al. (Journal of the American Chemical Society 130.9: 2780-2782, published 2008).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on Dec. 10, 2024, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of Hou et al., are applied here as discussed above.
Regarding claim 17-22, Hou does not explicitly state obtaining an average control data from a population having a known immune system or regarding a higher or lower immune function in a subject.
However, Casabianca et al teaches further comprising obtaining an average control data value or range of control data values from a population having a known immune system function, status and/or activity; and wherein when the comparative data value deviates from the average control data value or range of control data values indicates a higher or lower immune function, status and/or activity in the subject regarding HIV and an increase in CD4+ T cells (abstract, Tables 1-3 and Fig. 4).
Regarding claim 17-22, Casabianca et al teaches wherein when the comparative data value is lower than the average control data value or range of control data values indicates a decrease in immune function (abstract, Tables 1-3 and Fig. 4). Casabianca et al teaches wherein the known immune system function, status and/or activity comprises a population known to have a healthy immune function, status and/or activity; and wherein when the comparative data value is higher than the average control data value or range of control data values indicates an elevated immune response (abstract, Tables 1-3 and Fig. 4). Casabianca et al teaches wherein the elevated immune response is a result of an infection (see conclusions section). Casabianca et al teaches wherein the function, status, and activity of the immune system indicates a health condition of the subject (see conclusions section). Casabianca et al teaches wherein the health condition comprises detection and/or diagnosis of diseases that involve an immune response (see conclusions section).
Accordingly, it would have been obvious to modify the method of Hou et al and further obtain an immune system population as taught by Casabianca et al because Casabianca et al teaches that HIV-1 RNA levels and CD4+ T lymphocyte counts are the standard markers used in clinical practice for the management and the monitoring of HIV-1 infected patients (see intro para. 3). Furthermore, Huo teaches that the elucidation of the significance of biomolecule complexes for certain disease states, which in turn enables the diagnosis of disease states based on the identity and complexing level of a biomolecule complex in a particular biological sample (see e.g. abstract). Therefore, a person of ordinary skill in the art would have combined similar methods of detection for diseases, which would have led to predictable results with a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. medical diagnostics) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claims 67-68, as stated supra, Huo discloses wherein the at least one molecule component comprises an antibody (para. 7, Fig. 4). Further Hou et al., discloses that “protein aggregate formation is a significant and challenging problem in biopharmaceutical development. To use proteins as therapeutic agents, they need to be formulated into high concentration solutions” (see e.g. para. 31). Further, Huo discloses the rapid increase of the nanoparticle probe size corresponds to specific binding of target protein EGFR to the probe, while the slow and small size increase of mouse IgG1-AuNP probe is indicative of non-specific interactions (para. 27, fig. 4). Additionally, Huo discloses that in the IgG assay, mice with small tumor grown from LnCaP cells exhibit higher level of IgG than the other two groups (FIG. 7B), which reads on the claim limitation of wherein the immune therapy is an immune boosting therapy (i.e. increases humoral or cellular immune response) if the subject is determined to have an underdeveloped immune system.
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the Huo and incorporate immune therapy to a subject because Hue discloses the elucidation of the significance of biomolecule complexes for certain disease states, which in turn enables the diagnosis of disease states based on the identity and complexing level of a biomolecule complex in a particular biological sample (abstract). Therefore, it would have been obvious to combine prior art elements according to known methods to yield predictable results. Furthermore, an artisan of ordinary skill in the art of (i.e. medical diagnostics) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 69-70, as stated supra, Huo teaches wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product (para. 9, Fig. 1).
Hou et al., does not explicitly state wherein the analyzing comprises the assay product property comprising an optical property, or the device is a spectrophotometer device.
However, Hou cites the prior art of Liu which discloses that “the magnitude of light scattering by a gold nanoparticle can be orders of magnitude higher than light emission from strongly fluorescing dyes. This unique property has enabled many important and promising applications of metal nanoparticles in the biomedical field, such as molecular and cell imaging, biosensing, bioassays, and photothermal therapy” (See e.g. page 2780).
Regarding claim 69-70, Liu discloses that Dynamic light scattering (DLS), also known as photon correlation spectroscopy or quasi-elastic light scattering, is a technique used widely for particle size and size distribution studies (see e.g. page 2780), corresponding to the claim limitation of the assay product property comprising an optical property wherein the device is a spectrophotometer.
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Hou and incorporate the assay product as taught by Liu because Liu discloses that light scattering by metal nanoparticles can be detected directly by a fluorescence spectrometer and further used for quantitative DNA detection (see e.g. page 2782). Incorporating the analyzing device from Liu with the analyzing step as taught by Hou would have led to predictable results with a reasonable expectation of success because Hou cites Liu for teaching an immune assay using gold nanoparticles. Additionally, both Hou and Liu use gold nanoparticles in their methods. Therefore, incorporating a spectroscopy device for immunotherapy would have led to predictable results with a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. detection assays or medical diagnostics) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues that “Casabianca does not teach an assay substance, wherein the assay substance that binds to a molecular component in blood or blood component by non-specific interactions. As such, the combination of the Burckhardt and Casabianca reference do not teach all of the elements of claim 1, and in turn dependent claims 17-22, as would be required to establish a prima facie case of obviousness” (Remarks, page 8-9).
Applicant’s arguments with respect to the previous rejection of claims 17-22 as rejected as being obvious over Burckhardt in further view of Casabianca, Anna, et al. (PLoS One 9.11 :e111919, 2014), have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Huo (US20130052661A1 App. No. 13/522,391, published 2013, prior art of record) in view of as applied to Claim 1-2, 5, 7, 9, and 12-15, in further view of Casabianca, Anna, et al. (PLoS One 9.11: e111919., published 2014, prior art of record) and Liu, Xiong, et al. (Journal of the American Chemical Society 130.9: 2780-2782, published 2008).
In response to Applicants argument regarding Casabianca, as stated supra, Casabianca is cited for teaching Casabianca methods for obtaining an average control data value or range of control data values from a population having a known immune system function, status and/or activity from HIV DNA forms in the blood of HIV-1 infected Patients (see e.g. title, abstract, Tables 1-3 and Fig. 4). Casabianca is not cited for teaching the assay substance that binds to a molecular component in blood or blood component by non-specific interactions. As stated above, Hou is cited for teaching the assay substance that binds to a molecular component in blood or blood component by non-specific interactions. Contrary to Applicants assertion, Hou discloses the binding of proteins to the gold nanoparticles (AuNP) through non-specific interactions (see e.g. para. 10, fig. 1).
As stated above, it would have been obvious to modify the method of Hou et al and further obtain an immune system population as taught by Casabianca et al because Casabianca et al teaches method for monitoring the blood of HIV-1 infected patients (see e.g. title, abstract, intro para. 3). Furthermore, Huo teaches that the elucidation of the significance of biomolecule complexes for certain disease states, which in turn enables the diagnosis of disease states based on the identity and complexing level of a biomolecule complex in a particular biological sample (see e.g. abstract). Therefore, a person of ordinary skill in the art would have combined similar methods of detection for diseases, which would have led to predictable results with a reasonable expectation of success.
Applicants are reminded that the test for obviousness is not whether the features of a secondary reference maybe bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413,208 USPQ 871 (CCPA 1981).
Applicant asserts that “new claims 67-70 meet the criteria of patent eligibility and nonobviousness reciting additional method steps that involve administering an immune therapy and more specifically recite unconventional techniques in determining assay properties of the non-natural assay product” (Remarks, page 9).
Applicant’s arguments with respect to the previous rejection of the claims obvious over Burckhardt in further view of Casabianca, Anna, et al. (PLoS One 9.11 :e111919, 2014), have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Claims 17-22 and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Huo (US20130052661A1 App. No. 13/522,391, published 2013, prior art of record) in view of as applied to Claim 1-2, 5, 7, 9, and 12-15, in further view of Casabianca, Anna, et al. (PLoS One 9.11: e111919., published 2014, prior art of record) and Liu, Xiong, et al. (Journal of the American Chemical Society 130.9: 2780-2782, published 2008).
As stated supra, Liu discloses that Dynamic light scattering (DLS), also known as photon correlation spectroscopy or quasi-elastic light scattering, is a technique used widely for particle size and size distribution studies (see e.g. page 2780), corresponding to the claim limitation of the assay product property comprising an optical property wherein the device is a spectrophotometer. Accordingly, in the lack of evidence to the contrary one of ordinary skill in the art would have considered modifying the methods of Hou and incorporate the assay product as taught by Liu because Liu discloses that light scattering by metal nanoparticles can be detected directly by a fluorescence spectrometer and further used for quantitative DNA detection (see e.g. page 2782). Consequently, the prior art recognizes the new claims that involve administering an immune therapy and more specifically unconventional techniques in determining assay properties of a non-natural assay product. Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No Claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
Prosecution Insights