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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on the 1st of December 2025 has been entered.
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 March 17, 2018.
Election/Restrictions
Applicant’s species election without traverse of metal particles; color; complement protein in the reply filed on Jan. 9, 2024, is acknowledged.
However, the species election mailed on Jan. 9, 2024, has been re-considered in view of the prior art. The analyzing step (i.e. size, color, and light scattering) and the molecule component (i.e. antibody or complement protein) thereof is rejoined. Therefore, claims 8 is rejoined.
Claims 3-4, and 6, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Status of the Claims
In the response filed on Dec. 1st, 2025, Applicant has amended claims 1 and 22, and canceled claims 10-11, 13-14, 16, and 23-67.
Claims 3-4, and 6, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of metal particles, there being no allowable generic or linking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 68-70 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Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment.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.
Claim Objections
Claim 4 is objected to because of the following informalities: the status of the claim should be indicated as “withdrawn” and not “previously presented and withdrawn.” Appropriate correction is required.
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, 17-22, and 68-70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to the previous rejection set forth in the previous office action, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
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; and administering an immune therapy to 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 “analyzing” and “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 related to an abstract idea. 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 8, dependent on claim 1, recites “wherein the analyzing step comprises determining a size of the assay product”. Claim 9 just describes the analyzing step. Therefore, claim 8 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.
Regarding claim 68, dependent on claim 1, recites “wherein the immune therapy is an immune boosting therapy or immune suppressing therapy.” Claim 68 just describes the type of therapy and 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 69-70, dependent on claim 1, recites “wherein the analyzing comprises subjecting the assay product to a device under conditions to determine an assay product property, the assay product property comprising optical, electrical and/or magnetic property. Claims 69-70 just describes the analyzing step and the device. Therefore, claims 69-70 do 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, 17-22, and 68-70 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 steps of the 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.
Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present an insignificant extra-solution activity for performing immune therapy to a subject which does not relate or integrate the abstract idea into a practical application.
In particular, claim 1 recites the additional limitation of “administering an immune therapy to the subject” which reads on an insignificant extra-solution activity. (MPEP § 2106.05(g)). When viewed in combination or as a whole, the recited additional elements do no more than add an insignificant extra-solution activity to the judicial exception; see MPEP § 2106.05(g) Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012). 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 8, dependent on claim 1, recites “wherein the analyzing step comprises determining a size of the assay product”. Claim 9 just describes the analyzing step. 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.
Regarding claim 68, dependent on claim 1, recites “wherein the immune therapy is an immune boosting therapy or immune suppressing therapy.” Claim 68 just describes the type of therapy and does not remedy the deficiency of claim 1. Thus, 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 69-70, dependent on claim 1, recites “wherein the analyzing comprises subjecting the assay product to a device under conditions to determine an assay product property, the assay product property comprising optical, electrical and/or magnetic property. Claims 69-70 just describes the analyzing step and the device. Thus, 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, 17-22, and 68-70 meet the requirements of step 2A as being directed to a judicial exception.
Step 2B Significantly More: The "significantly more" analysis, the Examiner must consider whether each claim limitation individually or as an ordered combination amounts to significantly more than the abstract idea. This analysis includes determining whether a claim is patent eligible if the claims recite structures or functions that transform the abstract idea in a manner that make the claim markedly different from the judicial exception.
For limitations that were categorized as "apply it" or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations is considered directed towards an immune therapy that is not related to carrying out the abstract idea. (See MPEP 2106.04(d) referencing MPEP 2106.05(h)).
Regarding claim 1, “administering an immune therapy to the subject” which reads on an insignificant extra-solution activity. Thus, the claim limitation after the comparing step in claim 1 does not 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 steps of the method that is beyond that which is well understood, routine, and conventional. 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 that includes additional elements that are sufficient to amount to significantly more than the judicial exception. 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 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 8, dependent on claim 1, does not add significantly more than the judicial exception. The claim recites “wherein the analyzing step comprises determining the size 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 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.
Regarding claim 68, dependent on claim 1, recites “wherein the immune therapy is an immune boosting therapy or immune suppressing therapy.” Claim 68 just describes the type of therapy and does not remedy the deficiency of claim 1. 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 69-70, dependent on claim 1, recites “wherein the analyzing comprises subjecting the assay product to a device under conditions to determine an assay product property, the assay product property comprising optical, electrical and/or magnetic property. Claims 69-70 just describes the analyzing step and the device. 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, 17-22, and 68-70 recite 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 incorporating the amendment of “administering an immune therapy to the subject” more clearly and logically pertains to patent eligible subject matter (Remarks, page 6).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
As discussed above, in step 2A Judicial Exception-Prong 2 (Judicial exception is integrated into a practical application): Prong 2 asks whether a claim recites additional elements 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 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).
In response to Applicants argument, the amendment of “administering an immune therapy to the subject” does not integrate the judicial exception into a practical application because the additional claim limitation (i.e. administering immune therapy) is not related to the abstract idea and only presents an insignificant extra-solution activity of performing any immune therapy to a subject. Thus, the claim limitation of administering immune therapy is recited in general terms and does not relate or integrate the abstract idea (i.e. method of evaluating function, status and/or activity of an immune system of a subject) into a practical application. Moreover, the abstract idea (i.e. method of evaluating function, status and/or activity of an immune system of a subject) is generally related to administering immune therapy and is not specifically related to the comparative data (i.e. data that is from comparing the assay product property and the correlative property) that is recited in the claim. Furthermore, there is no claim limitation recited in the claims that specifically integrate the abstract idea and the step of administering immune therapy.
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception and insignificant extra-solution activity MPEP § 2106.05(g). 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 2A, and therefore does not meet patent subject matter eligibility requirements, as discussed above.
Claim Rejections - 35 USC § 112
(Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5, 7, 9, 12, 15, 17-22, and 68-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is a new rejection.
Independent 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, wherein the assay substance binds to the at least one molecular component by non-specific interactions;” (see claim 1, lines 1-6).
However, the specification doesn't have adequate support in the disclosure for the generic subject that characterize any subject for evaluating the function, status and/or activity with an immune system. As written in the claim, “a subject” encompasses a broad genus that includes multiple groups of subjects, and given its broadest reasonable interpretation in light of the specification (i.e. invertebrates, fish, reptiles, birds, and mammals etc.), corresponding to any subject that has an immune system.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result, but the disclosure fails to sufficiently identify how the function is performed, or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
In analyzing whether the written description requirement is met for genus, “a subject”, the specification is first assessed to determine whether a representative number of species have been described by their complete structure of the genus.
Independent 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, wherein the assay substance binds to the at least one molecular component by non-specific interactions; 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; 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; and administering an immune therapy to the subject
However, the specification doesn't have adequate support in the disclosure for the generic “subject” that characterizes the ability to evaluate the function, status and/or activity of any subject with an immune system.
The specification discloses that the term subject refers to an animal, and that “typical examples of an animal include but are not limited to mammals. In specific embodiments, the subject is a human, dog, cat, cow, horse, pig, goat, sheep, rat, mouse, guinea pig, or a nonhuman primate” (specification para. 52). However, the specification only discloses using mouse and bovine IgG/IgM ELISA analyzes that were performed using commercial ELISA kits (see e.g. specification, para. 68, and Examples 1).
Furthermore, the specification teaches that “Using the method as described in Example 1 and Figure 3, it was found that calves with abnormal test scores tend to gain lower weight. Data presented in Figure 16 and Table 3 reveals a reverse correlation between calf weight and their immunity test score. Calves with abnormally high immunity scores are likely having a clinical or sub-clinical infection. Group 4 calves with lowest immunity test score and highest weight gain may be selected for breeding purpose, while Group 1 calves with the most abnormal test scores and lowest weight gain, may be treated separately to help improve their health and weight performance” (see specification, Example 6). Therefore, the specification fails to identify any subject with method of evaluating function, status and/or activity of an immune system.
The method of making the claimed invention is not well established at the time of filling. However, one of skill in the art would neither expect nor predict that the method of evaluating function, status and/or activity of an immune system as claimed would be applicable to any subject.
The prior art of Romo et al. (Immunology 148.2: 125-139., published 2016), teaches that “across jawed vertebrates, innate immunity displays a diversity of mechanisms that adapt to the anatomy and behavior of different species, while preserving its core elements and main functions. Physical barriers are conserved across all vertebrates, nevertheless they have anatomical and chemical variations that exhibit a tendency to specialization of the skin and mucosa. Besides, among humoral components lysozyme, AMPs, complement system and NAbs are the most conserved, showing the same basic functions and sharing their main properties. On the other hand, the acute phase response and cytokine release are conserved mechanisms, triggered in the presence of pathogens, even though the involved molecules differ among vertebrate species. In general, humoral components are poorly characterized in amphibians and reptiles, making it difficult to understand the evolution of humoral innate immunity in vertebrates”(page 136). Therefore, Romo et al., provides robust evidence that immune system molecules differ among vertebrate species and are poorly characterized in amphibians and reptiles and that one of ordinary skill in the art would not be able to use the immune system method for any subject.
Additionally, the post filing art of Ruiz, Vania Lopez, and Jacques Robert (Philosophical Transactions of the Royal Society B; 378.1882: 20220123, published 2023) discloses that “As in all jawed vertebrates, the development of T cells in X. laevis and all anuran amphibians occurs in the thymus, which is a primary lymphoid organ that derives early during embryogenesis from the third pharyngeal pouch. The thymus provides an epithelial microenvironment specialized in the generation and selection of T cells. By contrast, the differentiation of other immune cells including B cells and leucocytes in amphibians typically takes place in the spleen and the liver, whereas the role of bone marrow, a primary lymphoid organ in mammals, is generally more rudimentary in amphibians” (see e.g. section 2. Lymphoid organs, tissue and cells). Therefore, Ruiz, Vania Lopez, and Jacques Robert provides additional evidence that the immune system of an amphibian is different from mammals. Therefore, with these additional evidence, the ordinary artisan cannot predictably evaluate function, status and/or activity of an immune system of any subject.
Furthermore, functionally defined genus claims can be inherently vulnerable for lack of adequate written description, especially in highly unpredictable technology fields, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 ("[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
As discussed above, the Applicant has recited that that the term “subject” refers to an “animal”, and that “typical examples of an animal include but are not limited to mammals. In specific embodiments, the subject is a human, dog, cat, cow, horse, pig, goat, sheep, rat, mouse, guinea pig, or a nonhuman primate” (specification para. 52).
Given the breadth of any “subject” that the claims embrace, a description of animals and the teachings of two groups (i.e. murine and bovine) of mammals, fails to provide a representative number of species that teaches the complete structure of the genus “subject” (i.e. invertebrates, fish, reptiles, birds). Consequently, any subject is not apparent to one of ordinary skill in the art from the description present in the specification. Therefore, an artisan of ordinary skill could not envision all the embodiments encompassed by the breadth of the claims.
Accordingly, the specification doesn't have adequate support in the disclosure for the generic subject that can characterize any subject with a method of evaluating the function, status and/or activity of an immune system of the subject. Similarly, the disclosure doesn't identify a generic subject that characterizes any subject with a method of evaluating the function, status and/or activity of an immune system of the subject. Therefore, the claimed recitation of any subject doesn't have an adequate written description. Furthermore, neither the specification nor the art indicates the ability to identify a generic subject that characterizes any subject with a method of evaluating the function, status and/or activity of an immune system of the subject.
Therefore, it concludes that the claimed recitation of any subject with a method of evaluating the function, status and/or activity of an immune system of the subject doesn't have an adequate written description. Specifically, the specification does not identify the generic subject to characterize any subject that can be associated with a method of evaluating the function, status and/or activity of an immune system of the subject. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed.
Claim Rejections - 35 USC § 112
(Scope of Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9, 17-22, 68-69 and 70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
a method of evaluating function, status and/or activity of an immune system of a mammalian subject, the method comprising; mixing a metal nanoparticle with a blood or blood component from the subject to form an assay product that comprises at least one unit of a metal nanoparticle and at least one component of a blood or blood component, wherein the metal nanoparticle binds to the component by a non-specific interaction; 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; 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; and administering an immune therapy to the subject.
does not reasonably provide enablement for the full scope of the claims:
a method of evaluating function, status and/or activity of an immune system of any subject, the method comprising; mixing any assay substance with a blood or blood component from the subject to form an assay product that comprises any assay substance and at least one molecular component of the blood or blood component, wherein the any assay substance binds to any molecular component by non-specific interactions; 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.
This rejection is a new rejection.
The specification does not enable any person skilled in the art to which it pertains or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the specification; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirements, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experimentation to make and use the invention based on the content of the disclosure is “undue”.
The breadth of the claims and the nature of the invention: With respect to claim breadth, the standard under 35 U.S.C. §112(a) entails determining what the claims recite and what the claims mean as a whole. The claims are drawn to “a method of evaluating function, status and/or activity of an immune system of a mammalian 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, wherein the assay substance binds to the at least one molecular component by non-specific interactions” (See claim 1).
The broadest reasonable interpretation (BRI) of the method of the claimed invention encompasses a method of evaluating function, status and/or activity of an immune system of any subject, the method comprising; mixing any assay substance with blood or blood component from the subject to form an assay product that comprises at least one unit of the any assay substance and at least one molecular component of the blood or blood component, wherein the any assay substance binds to the at least one molecular component by non-specific interactions (See claim 1).
The nature of the invention is a method of evaluating function, status and/or activity of an immune system of any subject, the method comprising; mixing any assay substance with blood or blood component from the subject to form an assay product that comprises at least one unit of the any assay substance and at least one molecular component of the blood or blood component, wherein the any assay substance binds to the at least one molecular component by non-specific interactions. A skilled artisan would not be able to use the method as claimed with a reasonable expectation of success based solely on what is disclosed in the specification.
As such, the claim is vastly broad encompassing embodiments contemplated and not contemplated by the specification.
Specification Guidance/Working Examples:
Briefly, the specification does not demonstrate:
a method of evaluating function, status and/or activity of an immune system of any subject.
mixing any assay substance with any blood or blood component from the subject to form any assay product.
forming any assay product that comprises any assay substance and any molecular component of the blood or blood component.
The specification does teach the following:
“An extremely simple, gold nanoparticle-enabled blood test was devised that can monitor the general immune system development and immune health of animals from neonates to adulthood” (Spec. para. 72, Example 1).
“The test detects primarily an increased amount of immunoglobulin M (IgM), but also immunoglobulin G (IgG) antibody in the blood. Study also found complement proteins such as C3 is involved in the interaction between gold nanoparticles and blood serum” (Spec. para. 73, Example 1).
“Upon incubation, immunoglobulin proteins such as IgM and IgG, along with other proteins and biomolecules such as complement proteins from the serum can adsorb to the AuNPs to form a so-called "protein corona" on the nanoparticle surface”. (Spec. para. 73, Example 1).
“In light of the experimental evidence presented so far, we believe a cooperative interaction occurs between citrate-AuNPs and IgM, IgG, and complement protein C3 as illustrated in Figure 1 when the AuNP is mixed with a blood serum samples” (see e.g. Spec. para. 83, Example 1, and Spec. para. 92, Example 4).
“In summary, the findings provided herein demonstrate an extremely simple-to-perform, rapid blood test to evaluate the humoral immunity and immunity development of animals from neonates to adults. A direct correlation between the nanoparticle test score and the antibody level in the blood was established in both murine and bovine models. A low score in the nanoparticle test corresponds to a poor or under-developed humoral immunity of the animals” (Specification para. 87).
Accordingly, the specification fails to provide specific guidance to forming any assay product that comprises any assay substance and any molecular component of the blood or blood. As discussed above, the specification discloses utilizing a “protein corona,” comprising gold nanoparticles and immunoglobin proteins that form on the nanoparticle surface through cooperative interactions. Thus, the specification fails to provide specific guidance to any assay substance that binds to any molecular component by a non-specific interaction. Therefore, the specification only enables gold nanoparticle-enabled blood test was devised that can monitor the general immune system development by measuring the cooperative interaction of citrate-gold nanoparticles (i.e. AuNPs) when the AuNPs are mixed with a blood sample.
State of the Art: Regarding the claim encompassing: “any assay substance” and “any molecular component of the blood” as a method of evaluating function, status, and/or activity of an immune system of a subject. At the time of the effective filing, the prior art of Roberto Reverberi, and Lorenzo Reverberi (published 2007, hereinafter as “Reverberi”), discloses that the specific binding between the antigenic determinant on the red cell (epitope) and the antigen-combining site on the immunoglobulin molecule (paratope) involves very small portions of molecules (see e.g. page 227). Thus, Reverberi provides evidence that a person of ordinary skill in the art would use specific binding to evaluate the function, status, and/or activity of an immune system. Further, the prior art of Muthana et al, (published 2015), discloses that “detection of serum anti-glycan antibodies is typically carried out by immobilizing a carbohydrate of interest, capturing specific antibodies, and then measuring amounts of bound antibodies” (page 2). Further, Muthana teaches the evaluation of “the detection of secondary antibodies to confirm their specificities and validate their use in developing a multiplexed microarray-based assay (see S1 File). From the SDS-PAGE gels and western blots of purified antibodies from human pooled serum (IgA, IgG, and IgM), we confirmed that the secondary antibodies have no cross-reactivity with other isotypes (Fig. A, S1 File)”. Therefore, Muthana discloses examples of how a person of ordinary skill in the art would want specific interactions between an antibody with a subject’s blood in order to accurately measure the amount of bound antibodies. Thus, the prior art Muthana provides robust evidence that not any assay substance with any blood component will produce any assay product by non-specific interactions.
Additionally, the prior art of Walkey et al., (Chemical Society Reviews 41.7: 2780-2799, published 2012) discloses that the “identity of the nanomaterial (size, aggregation state, and protein corona) determines its interactions with biomolecules and biological barriers in a physiological environment” and that “both specific and nonspecific adsorption of an antibody is possible, depending on the nanomaterial formulation” (see e.g. page 2792). Further, the prior art of Lundgren et al., (ACS nano 10.11: 9974-9982, published 2016), teaches that that the interactions of “NPs (i.e. gold-core nanoparticles) to membrane receptors can be strongly dependent on weak, colloidal interactions between the lipid membranes and NPs. For example, attractive van der Waals forces give rise to a NP size-dependent, nonhomogeneous distribution of NPs near the membrane. In particular, due to their larger van der Waals interaction, the residence time in the vicinity of the interface is longer for larger than for smaller NPs” (see e.g. page 9980, and fig. 1). Therefore, the prior art of Walkey et al. and Lundgren et al. provide robust evidence that nanomaterial formulation is essential to the assay substance when mixing the assay substance with a subject’s blood, because not any assay substance will mix with any blood component to produce any assay product by a non-specific interaction.
Accordingly, the art at the time of the invention teaches that a method of evaluating function, status and/or activity of an immune system of a mammalian subject, the method comprising; mixing a metal nanoparticle material as the assay substance with a blood or blood component from the subject by non-specific interactions, but a generic assay substance fails to mix with any blood or blood component from the subject by a non-specific interaction. Thus, the breadth of mixing any assay substance with any blood or blood component from the subject to form any assay product that comprises at least one unit of any assay substance and at least one molecular component of the blood or blood component, wherein the assay substance binds to the at least one molecular component by non-specific interactions fails to predictably have any assay substance bind by non-specific interactions to evaluate the function, status and/or activity of an immune system of a subject as claimed. As such, similar to the specific, the art teaches that the claimed the any assay substance fails to predict any 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, wherein the assay substance binds to the at least one molecular component by non-specific interactions.
Thus, the art at the time of the invention teaches that a method of evaluating function, status and/or activity of an immune system of a mammalian subject, the method comprising; mixing a metal nanoparticle material as the assay substance with a blood or blood component from the subject by non-specific interactions but that a generic assay substance fails to mix with any blood or blood component from the subject by a non-specific interaction as claimed. Thus, the breadth of any assay substance mixing with any blood component by non-specific interaction fail to predictably evaluate the function, status, and/or activity of any subject’s immune system as claimed. As such, similar to the specification, the art teaches that the claimed any assay substance mixing with any blood component by non-specific interaction fails to evaluate the function, status, and/or activity of any subject’s immune system.
Thus, in conclusion, the breadth of the claims to a method of evaluating function, status and/or activity of an immune system of any subject, the method comprising; mixing any assay substance with blood or blood component from the subject to form an assay product that comprises at least one unit of the any assay substance and at least one molecular component of the blood or blood component, wherein the any assay substance binds to the at least one molecular component by non-specific interactions is not enabled for any assay substance and any molecular component of the blood. The specification solely provides specific guidance to a nanoparticle-enabled blood test that can monitor the general immune system development by measuring a cooperative interaction that occurs between citrate-AuNPs that are mixed with blood samples, as discussed above, and fails to describe any other means of mixing any assay substance with blood or blood component from the subject to form any assay product that will evaluate the function, status and/or activity of an immune system of any subject.
Therefore, at the time of filing the skilled artisan would need to perform an undue amount of experimentation without a predictable degree of success to implement the invention as claimed.
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 8-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 8-9 recited the limitation of the “analyzing step” in lines 1, respectively. There is insufficient antecedent basis for the claim limitation of “analyzing step” (see claim 9, line 1), because claim 1 recites analyzing the assay product (line 7) and the “comparing the assay product” (line 10), and does not recite the phrase “analyzing step”. Thus, there is a lack of insufficient antecedent basis for this limitation in the claim and renders the claim indefinite because there is no prior recitation of any “step” as a claim limitation. Therefore, the recitation of an “analyzing step” is indefinite because it is not apparent as to what step the “analyzing step” is referring to, given that the base claims does not require just one “analyzing step”. Therefore, it is not apparent to what the analyzing step limitations refer.
For compact prosecution the claim will be interpreted as the analyzing step as referring to the step of “analyzing the assay product” (claim 1, line 7).
The prior art rejections below are directed to the scope that is enabled.
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, 15, 17-19, 21-22, and 68-70, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Qun, Huo (US2013/0058923 A1, App. No. 13/566,195, published 2013, hereinafter “Qun,” cited IDS 4/21/2021).
This rejection is a new rejection necessitated by amendments to the claims.
Regarding Claim 1-2, 7-8, and 12, Qun discloses a method of evaluating function, status and/or activity of an immune system of a subject (see e.g. Examples 1-3 and claim 1). Further, Qun discloses mixing an assay substance (i.e. gold nanoparticles, AuNPs) with a blood or blood component (e.g. serum) from the subject to form an assay product (i.e. particle or corona size)(see e.g. Examples 1-3 and claim 1), comprising at least one unit of the assay substance (i.e. AuNP) and at least one molecular component of the blood or blood component (i.e. human IgG, huIgG)(see e.g. Examples 1-3 and claim 1), corresponding to the claim limitation wherein the assay substance binds to the at least one molecular component by non-specific interactions(i.e. adsorption of human IgG to the AuNPs)(see e.g. para. 9, Examples 1-3 and claim 1). Further, Qun teaches analyzing the assay product under conditions to determine an assay product property (i.e. size), the assay product property comprising a physical, chemical, optical, electrical, or magnetic property (see e.g. Examples 1-3, claim 14). Qun teaches comparing the assay product property (i.e. size of AuNPs with tumor tissue lysate) with a correlative property of an unexposed assay substance (i.e. size of AuNPs with serum normal tissue lysate) 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 (see e.g. Examples 1-3). Further, Qun discloses administering an immune therapy to the subject (see e.g. para. 36, Examples 1-3, and claim 1).
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 (para. 9, Examples 1-3 and 6).
Regarding Claim 9, Qun discloses wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product (see e.g. para. 21, claim 14, Example 1-6).
Regarding Claim 15, Qun discloses wherein the at least one molecule component comprises an antibody (para. 7, Fig. 4).
Regarding Claim 17, Qun discloses 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 (i.e. particle size of normal patients); and wherein when the comparative data value deviates from the average control data value or range of control data values indicates a lower immune function, status and/or activity in the subject (i.e. prostate cancer patients)(see e.g. fig. 8, Example 1-3).
Regarding Claim 18, Qun discloses wherein when the comparative data value (i.e. NP size) is lower than the average control data value or range of control data value indicates a decrease in immune function (i.e. cancer progression)(see e.g. para. 63, fig. 6, Example 2).
Regarding Claim 19, Qun discloses the average particle size of serum-AuNP where serums samples were spiked with prostate tissue lysates from normal, tissue with Grade 1, Grade 2, and Grade 3 prostate adenocarcinoma (see e.g. Fig. 2 and 9), corresponding to the claim limitation wherein the comparative data value (i.e. NP size) is higher than the average control data value or range of control data value indicates an elevated immune response (see e.g. fig. 2 and 9, Examples 1-5).
Regarding Claim 21-22, as stated supra, Qun discloses wherein the function, status, and activity of the immune system indicates a health condition (i.e. cancer) of the subject, which comprises the detection of disease (i.e. cancer) that involve an immune response (e.g. molecules released from the prostate tumor tissue and human IgG) (see e.g. fig. 2 and 9, Examples 1-5).
Regarding claim 68, Qun discloses wherein the immune therapy is an immune boosting therapy if the subject is determined to have an underdeveloped immune system (see e.g. para. 72, Example 6).
Regarding claim 69-70, as stated supra, Qun discloses wherein the analyzing step comprises subjecting the assay product to a device (e.g. dynamic light scattering (DLS) or microscopy etc.(see claim 14)) measuring optical, electrical and/or magnetic property, corresponding to the claim limitation wherein the device is a spectrophotometer or an electrometer (see e.g. para. 21, claim 14, Example 1-6).
Accordingly, Qun anticipates the instant claims.
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 20 is rejected under 35 U.S.C. 103 as being unpatentable over Qun Huo (US2013/0058923 A1, App. No. 13/566,195, published 2013, hereinafter “Qun”), as applied to claims 1-2, 5, 7-9, 12, 15, 17-19, 21-22, and 68-70, above, and further in view of Huo et al., (US8883094B2, published 2014, hereinafter as “Huo”) as evidence by Zheng, et al. (ACS infectious diseases 3.11: 866-873, published 2017, cited IDS 8/21/2025) and Bitterman, Roni, et al. (Cochrane Database of Systematic Reviews 2, published Feb. 2018, hereinafter as “Bitterman”).
This rejection is a new rejection necessitated by amendments to the claims.
The teachings of Qun apply here as indicated above.
Regarding claim 20, Qun is silent regarding wherein the elevated immune response is a result of an infection.
However, the prior art of Huo discloses that metal nanoparticles may be used to monitor and detect bacteria and viruses in a subject (see e.g. col. 3 and 6). Further, Zheng evidences that virus-elicited immunoglobulin G (IgG) antibody are present in the protein corona of a gold nanoparticle surface upon mixing the gold nanoparticles with blood serum (see e.g. abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Qun and combine the method of monitoring and detecting an elevated immune response that is the result of a bacterial or viral infection as taught by Huo as evidence by Zheng because one would have been ablet to detect virus-elicited immunoglobulin G (IgG) antibodies with mental nanoparticles in a subject’s blood with a reasonable expectation of success. One of ordinary skill in the art would have done so because immunosuppressed cancer patients are known to be at increased risk of serious influenza-related complications as evidence by Bitterman (see e.g. abstract). Further, Qun, Huo and Zheng use metal (i.e. gold) nanoparticles to monitor and detect immunoglobulin G (IgG) antibodies (see e.g. Examples 1-3 of Qun, Example 5 of Huo, and Fig. 6 of Zheng). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 1-2, 5, 7-9, 12, 15, and 68-70 are rejected under 35 U.S.C. 103 as being unpatentable over Dobrovolskaia, et al., (Nanomedicine 5, 106−117, published 2009, hereinafter as “Dobrovolskaia”), and Paciotti, et al. (Drug delivery 11.3: 169-183, published 2004, hereinafter as “Paciotti”).
This rejection is a new rejection necessitated by amendments to the claims.
Regarding Claim 1, 2, 5, 7-8 and 12, Dobrovolskaia discloses a method of evaluating function, status and/or activity of an immune system of a subject (i.e. complement activation and plasma coagulation)(see e.g. page 109, 114-116, Table 2, Fig. 4-6). Dobrovolskaia discloses the method comprising; mixing an assay substance (i.e. colloidal gold nanoparticles, AuNP) with a blood or blood component from the subject (i.e. pooled sodium citrate plasma) to form an assay product (i.e. particles, nanoparticles, or protein corona)(see e.g. methods section pages 107-110, and fig. 1) that comprises at least one unit of the assay substance (i.e. colloidal gold nanoparticles) and at least one molecular component of the blood or blood component (i.e. pooled sodium citrate plasma)(see e.g. page 107), corresponding to the claim limitation wherein the assay substance binds to the at least one molecular component by non-specific interactions (see e.g. page 116). Dobrovolskaia discloses analyzing the assay product (i.e. particles, nanoparticles, or protein corona) under conditions to determine an assay product property (e.g. particle size), the assay product property comprising a physical, chemical, optical, electrical, magnetic, and/or mechanical property (e.g. microscope or dynamic light scattering)(see e.g. page 108-109, Table 1, fig. 1, 3, and 5). Further, Dobrovolskaia discloses comparing the assay product property (e.g. particle size) with a correlative property (e.g. particle size) of an unexposed assay substance (i.e. untreated particles) 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 (see e.g. pages 108-109, 115-116, and fig. 1).
Dobrovolskaia is silent regarding administering an immune therapy to the subject.
However, Dobrovolskaia cites the prior art of Paciotti which discloses that colloidal gold nanoparticles has been known to be used as a therapeutic for the treatment of cancer as well as an indicator for immunodiagnostics (see e.g. page 169). Further, Paciotti teaches administering gold nanoparticles as based drug delivery system for administering tumor necrosis factor (TNF) as an immune therapy to target cancer in a subject (see e.g. page 172, 175, fig. 2, and 4-5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the methods of Dobrovolskaia and incorporate the administration of immune therapy as taught by Paciotti because both Dobrovolskaia and Paciotti disclose that using gold nanoparticles are a promising drug delivery platform for immune therapy (see e.g. page 106 and 170, respectively). Additionally, both Dobrovolskaia and Paciotti disclose methods of colloidal gold nanoparticles interacting with a subject’s blood (see e.g. fig. 1 and fig. 4, respectively). Further, both Dobrovolskaia and Paciotti disclose methods of analyzing the particles size by microscopy and light scattering (i.e. transmission electron microscopy (TEM) and dual light scattering (DLS)(see e.g. pages 108 and 172, respectively). Thus, a person of ordinary skill in the art would have had predictable results of incorporating the administration of immune therapy with a reasonable expectation of success.
Regarding Claim 9, Dobrovolskaia discloses wherein the analyzing step comprises observing or determining the color and/or light scattering property of the assay product (see e.g. fig. 1 and fig. 5).
Regarding Claim 15, Dobrovolskaia discloses wherein the at least one molecule component comprises an antibody or a complement protein (see e.g. Table 2 and fig. 5).
Regarding claim 68, Dobrovolskaia is silent regarding wherein the immune therapy is an immune boosting therapy.
However, as stated supra, Dobrovolskaia cites the prior art of Paciotti which discloses wherein the immune therapy is an immune boosting therapy (i.e. enhance additional immunotherapy) if the subject is determined to have an underdeveloped immune system (i.e. cancer)(see e.g. page 178, 182 and fig. 5-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the methods of Dobrovolskaia and incorporate the administration of immune therapy as taught by Paciotti because both Dobrovolskaia and Paciotti disclose methods that use gold nanoparticles (see e.g. page 106 and 170, respectively). Additionally, Paciotti discloses that administering tumor necrosis factor (TNF), which is known to induce direct antitumor effects on a variety of tumor phenotypes, with the use of colloidal gold nanoparticles to a subject with cancer improves the efficacy of tumor targeted drug delivery (see e.g. pages 180-182, fig. 6). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 69-70, as stated supra, Dobrovolskaia teaches wherein the analyzing step comprises subjecting the assay product to a device (i.e. dynamic light scattering (DLS) and transmission electron microscopy (TEM)) measuring optical, electrical and/or magnetic property, corresponding to the claim limitation wherein the device is a spectrophotometer or an electrometer (see e.g. page 108-109, fig. 1-2, 5 and Table 1).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/PETER PARAS JR/ Supervisory Patent Examiner, Art Unit 1632
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