Analysis of U.S. Patent 10,335,464 for Pharmaceutical Applications

U.S. Patent 10,335,464, titled "Compositions and Methods for Treating Cancer," issued on July 2, 2019, to Tempus Solutions, Inc. The patent claims methods and compositions for identifying patients suitable for certain cancer therapies and for treating specific types of cancer. The core of the invention relates to analyzing genetic mutations, particularly those associated with tumor suppressor genes and oncogenes, to guide treatment decisions. The patent asserts novelty in the specific combinations of genetic markers and the predictive power of these markers for therapeutic response.

What Are the Key Claims of U.S. Patent 10,335,464?

The patent's independent claims, particularly claim 1 and claim 15, define the scope of the invention.

Claim 1: This claim describes a method for determining a therapeutic strategy for a subject diagnosed with cancer. It involves:
1. Obtaining a biological sample from the subject.
2. Detecting a genetic alteration in at least one of a predetermined set of genes. This set includes genes such as TP53, KRAS, EGFR, BRAF, and PIK3CA.
3. Analyzing the detected genetic alteration to classify the subject into a subpopulation.
4. Selecting a therapeutic strategy based on the subpopulation classification. The method specifically lists therapeutic strategies that may be selected, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy. The claim further specifies that the detection can be performed using a sequencing-based assay, such as whole exome sequencing or targeted gene panel sequencing.
Claim 15: This claim recites a composition of matter, specifically a kit for use in a method of claim 1. The kit includes:
1. A reagent set for detecting genetic alterations in the aforementioned predetermined set of genes.
2. A processor-readable medium storing instructions for:
  - Analyzing the detected genetic alterations.
  - Classifying the subject into a subpopulation.
  - Selecting a therapeutic strategy based on the subpopulation classification.

The patent also includes dependent claims that narrow the scope of the independent claims by specifying particular genes, types of genetic alterations (e.g., single nucleotide variants, insertions, deletions), specific cancer types (e.g., lung cancer, colorectal cancer, melanoma), and particular therapeutic agents.

What is the Technical Basis for the Patented Claims?

The technical basis of U.S. Patent 10,335,464 lies in the field of molecular oncology and personalized medicine. The invention posits that specific genetic alterations within a defined panel of cancer-related genes have prognostic or predictive value for treatment response. The patent proposes that by analyzing these alterations, clinicians can identify patient subpopulations that are more likely to benefit from specific therapeutic interventions.

The "predetermined set of genes" mentioned in the claims is central to the invention. This set is not exhaustively listed in the independent claims but is understood from the patent's specification and examples to include genes that are frequently mutated in various cancers and are known to play roles in cell growth, differentiation, and survival. These genes often fall into categories of oncogenes (genes that promote cell growth) and tumor suppressor genes (genes that inhibit cell growth).

The method involves obtaining a biological sample, typically tumor tissue or blood, and subjecting it to genetic analysis. Modern sequencing technologies, as alluded to in the claims, allow for the detection of various genetic alterations, including point mutations, insertions, deletions, and copy number variations. The patent suggests that the combination and specific types of alterations within this gene panel are key to the classification of patients and the subsequent selection of therapy.

For example, the patent may imply that the presence of a KRAS mutation in a colorectal cancer patient, when analyzed in conjunction with the mutational status of TP53 and EGFR, predicts a poor response to certain anti-EGFR monoclonal antibodies, thereby guiding the physician towards alternative treatment options. Conversely, specific BRAF mutations might indicate a patient is likely to respond to BRAF inhibitors. The patent therefore claims the system and method for generating this predictive information.

What is the Prior Art Landscape for Gene Mutation Analysis in Cancer Treatment?

The field of using genetic mutations to guide cancer therapy is highly active and has a significant prior art landscape. Numerous academic publications and patents have explored the correlation between specific gene mutations and treatment efficacy.

Key areas of prior art include:

Diagnostic and Prognostic Assays: Assays designed to detect known cancer-associated mutations have been in development and clinical use for many years. Examples include tests for EGFR mutations in non-small cell lung cancer (NSCLC) to guide the use of tyrosine kinase inhibitors (TKIs) like gefitinib and erlotinib, and BRAF V600E mutations in melanoma to guide treatment with BRAF inhibitors like vemurafenib.
Gene Panels and Next-Generation Sequencing (NGS): The development of multiplexed gene panels and NGS technologies has enabled the simultaneous analysis of multiple cancer-associated genes. Companies like Foundation Medicine, Caris Life Sciences, and Guardant Health offer comprehensive genomic profiling services that detect hundreds of mutations across hundreds of genes in tumor samples. These services have been available commercially for years prior to the priority date of this patent.
Predictive Biomarkers: The concept of using biomarkers, including genetic mutations, to predict response to therapy is well-established. The Food and Drug Administration (FDA) has approved numerous companion diagnostics that identify patients likely to benefit from specific drugs based on genetic alterations (e.g., PD-L1 expression for immunotherapy, HER2 amplification for trastuzumab).
Published Research: A vast body of scientific literature exists detailing the mutational landscape of various cancers and its association with treatment outcomes. Studies frequently report on the significance of mutations in genes such as TP53, KRAS, EGFR, BRAF, and PIK3CA in predicting response to chemotherapy, targeted therapies, and immunotherapies.

The novelty of U.S. Patent 10,335,464 would therefore depend on whether it claims a specific, non-obvious combination of genes, or a novel method of analysis or interpretation that was not previously described or readily apparent to a person skilled in the art. The breadth of the "predetermined set of genes" and the specific "therapeutic strategies" linked to subpopulation classifications are critical considerations.

What Are the Potential Commercial Implications and Market Landscape?

The commercial implications of U.S. Patent 10,335,464 are tied to the market for precision oncology diagnostics and therapeutics. The market for cancer diagnostics, particularly molecular diagnostics, is substantial and growing, driven by the increasing adoption of personalized medicine.

Diagnostic Companies: Companies offering comprehensive genomic profiling services that analyze panels of cancer genes are directly impacted. If the claims of 10,335,464 are interpreted broadly to cover existing gene panels and analytical methods, it could create licensing opportunities or litigation risks for these entities. The patent's value hinges on its ability to claim a unique or non-obvious subset of genes, an innovative analytical approach, or a specific interpretation algorithm that sets it apart from existing technologies.
Pharmaceutical Companies: Pharmaceutical companies developing targeted therapies and immunotherapies rely heavily on predictive biomarkers to identify patient populations most likely to respond to their drugs. If the patent claims are broad enough to encompass methods used in clinical trials or for patient stratification in approved indications, it could affect their R&D pipelines and commercial strategies. However, many targeted therapies are already approved based on specific, well-defined biomarkers (e.g., EGFR mutations for osimertinib). The patent’s impact would be greater if it covers a broader, more general method of patient stratification across multiple therapeutic classes.
Therapeutic Strategy Selection: The patent's claims regarding the selection of "therapeutic strategy" suggest an integration of genomic data with clinical decision-making. This aligns with the trend towards integrated diagnostics and treatment planning platforms.
Market Competition: The market for cancer diagnostics is highly competitive. The existence of such a patent necessitates careful landscape analysis for companies entering this space or developing new diagnostic tests. Freedom-to-operate analyses are crucial for new product development.
Licensing and Litigation: If the patent is deemed valid and broadly applicable, it could become a valuable asset for Tempus Solutions, Inc., potentially leading to licensing agreements with diagnostic and pharmaceutical companies. Conversely, it could also be a target for patent litigation from competitors seeking to invalidate its claims or design around them.

The patent's ultimate commercial impact will depend on the interpretation of its claims by the courts and the USPTO, and its ability to withstand challenges based on prior art.

What are the Key Intellectual Property Considerations and Potential Challenges?

The intellectual property landscape surrounding gene patenting and diagnostic methods is complex and has evolved significantly. U.S. Patent 10,335,464 faces several potential challenges and considerations:

Patent Eligibility (Subject Matter Eligibility): Under 35 U.S.C. § 101, claims directed to laws of nature, natural phenomena, or abstract ideas are generally not patent-eligible. The patent office and courts have scrutinized claims involving diagnostic methods and correlations between genetic mutations and diseases or treatment responses. To be patent-eligible, such claims often require significant human intervention or a novel and unconventional application of the discovered correlation. The claims in 10,335,464 are framed as methods and kits, which are generally patent-eligible forms, but their content will be assessed against the Alice/Mayo framework. The patent must demonstrate that it does more than simply state a natural correlation or an abstract idea.
Novelty and Non-Obviousness (35 U.S.C. §§ 102 & 103): The patent's claims must be novel and non-obvious over the prior art. Given the extensive research and commercial activity in cancer genomics, demonstrating that the specific combination of genes and analytical methods claimed was not previously known or would not have been obvious to a person of ordinary skill in the art is a critical hurdle. The prior art landscape, including published scientific literature and existing diagnostic panels, will be a primary focus for any challenge.
Claim Scope and Ambiguity: The precise scope of the "predetermined set of genes" and the definition of "genetic alteration" are crucial. If these terms are overly broad or ambiguous, they could render the claims invalid or difficult to enforce. The patent's specification must adequately define these terms and support the claimed methods.
Enablement and Written Description (35 U.S.C. § 112): The patent must adequately describe the invention so that a person skilled in the art can make and use it without undue experimentation (enablement) and clearly delineate the metes and bounds of the claimed invention (written description). If the patent fails to provide sufficient detail on how to perform the analysis or how to interpret the results for the claimed set of genes and therapies, it could be challenged on these grounds.
Inventorship: Ensuring correct inventorship is always a consideration in patent law. Disputes over inventorship can lead to patent invalidation.
Post-Grant Review and Inter Partes Review (IPR): Competitors can challenge the validity of issued patents through post-grant review proceedings at the USPTO, such as Inter Partes Review (IPR). These proceedings are often used to invalidate patents based on prior art.

The patent's claims are structured to define a method for guiding therapy based on genetic profiling. The strength of these claims will be tested against existing diagnostic practices, scientific literature, and evolving patent law interpretations, particularly concerning diagnostic methods and correlations.

Key Takeaways

U.S. Patent 10,335,464 claims methods and kits for classifying cancer patients based on genetic alterations in a predetermined set of genes to guide therapeutic strategy selection.
The patent's technical basis lies in correlating specific genetic mutations within key oncogenes and tumor suppressor genes with predicted therapeutic responses.
The prior art landscape includes extensive research and commercial offerings in cancer genomics, including comprehensive gene panels and predictive biomarker assays.
Commercial implications extend to diagnostic companies, pharmaceutical firms, and the broader precision oncology market, presenting potential licensing opportunities and litigation risks.
Key intellectual property challenges include patent eligibility under § 101, novelty and non-obviousness over prior art, and adequate enablement and written description.

Frequently Asked Questions

What specific genes are included in the "predetermined set of genes" in U.S. Patent 10,335,464?

While the independent claims refer generally to a "predetermined set of genes," the patent specification and dependent claims often provide examples of such genes, including but not limited to TP53, KRAS, EGFR, BRAF, and PIK3CA. The exact scope depends on the specific claim language and its interpretation in light of the specification.

Can existing genetic profiling services infringe on this patent?

Existing genetic profiling services could potentially infringe if their methods and claimed scope fall within the asserted claims of U.S. Patent 10,335,464. A freedom-to-operate analysis would be required to determine specific risks, considering the exact genes analyzed, the types of alterations detected, and the interpretive algorithms or therapeutic guidance provided.

What legal challenges might this patent face?

This patent could face challenges related to patent eligibility (i.e., whether it claims a law of nature or abstract idea), novelty, non-obviousness over existing prior art, and adequacy of written description and enablement. Legal challenges might also arise from competitors seeking to invalidate the patent through proceedings like Inter Partes Review.

Does this patent cover the use of any cancer therapy?

The patent claims methods for determining a therapeutic strategy. It does not claim specific cancer therapies themselves but rather the method of using genetic information to select a therapy. Therefore, it could impact the way certain therapies are prescribed based on patient genetic profiles.

How does this patent relate to companion diagnostics?

Companion diagnostics are tests that are approved alongside a specific drug to identify patients who are most likely to benefit from that drug. U.S. Patent 10,335,464 is broader as it claims a method for selecting a therapeutic strategy based on a panel of genetic alterations, which could encompass multiple therapeutic options beyond those linked to a single drug.

What is the significance of the kit claim (Claim 15)?

The kit claim provides a tangible form of the invention, encompassing reagents and instructions for performing the patented method. This broadens the scope of potential infringement and enforcement, as a kit manufactured or sold to perform the claimed analysis would be covered, in addition to the method itself.

Citations

[1] Tempus Solutions, Inc. (2019). U.S. Patent No. 10,335,464. Compositions and Methods for Treating Cancer. U.S. Patent and Trademark Office.

Title:	Device for titrating basal insulin
Abstract:	The invention relates to a novel administration regime useful in the treatment of diseases or conditions where administration of insulin will be of benefit. In particular, the invention relates to a long-acting or ultra-long acting insulin for use in treating a disease or condition where administration of insulin will be of benefit, wherein the administration of said insulin includes or consists of one or more of the following steps: (a) obtaining a first data set of the subject, (b) obtaining a second data set of the subject, (c) obtaining a first data structure of the subject, and (d) obtaining a second data structure of the subject. When a determination is made that the at least first data structure, second data structure, first data set, and second data set collectively do contain the set of evaluation information, the device further includes providing the long-acting or ultra-long-acting insulin dose guidance recommendation.
Inventor(s):	Michelich; Alan John (Seattle, WA), Miller; Thomas Dedenroth (Seattle, WA), Shvets; Oleksandr (Everett, WA), Imanbayev; Anuar (Seattle, WA), Van Orden; Brad (Seattle, WA)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	16/020,478
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Analysis of U.S. Patent 10,335,464 for Pharmaceutical Applications U.S. Patent 10,335,464, titled "Compositions and Methods for Treating Cancer," issued on July 2, 2019, to Tempus Solutions, Inc. The patent claims methods and compositions for identifying patients suitable for certain cancer therapies and for treating specific types of cancer. The core of the invention relates to analyzing genetic mutations, particularly those associated with tumor suppressor genes and oncogenes, to guide treatment decisions. The patent asserts novelty in the specific combinations of genetic markers and the predictive power of these markers for therapeutic response. What Are the Key Claims of U.S. Patent 10,335,464? The patent's independent claims, particularly claim 1 and claim 15, define the scope of the invention. Claim 1: This claim describes a method for determining a therapeutic strategy for a subject diagnosed with cancer. It involves: Obtaining a biological sample from the subject. Detecting a genetic alteration in at least one of a predetermined set of genes. This set includes genes such as TP53, KRAS, EGFR, BRAF, and PIK3CA. Analyzing the detected genetic alteration to classify the subject into a subpopulation. Selecting a therapeutic strategy based on the subpopulation classification. The method specifically lists therapeutic strategies that may be selected, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy. The claim further specifies that the detection can be performed using a sequencing-based assay, such as whole exome sequencing or targeted gene panel sequencing. Claim 15: This claim recites a composition of matter, specifically a kit for use in a method of claim 1. The kit includes: A reagent set for detecting genetic alterations in the aforementioned predetermined set of genes. A processor-readable medium storing instructions for: Analyzing the detected genetic alterations. Classifying the subject into a subpopulation. Selecting a therapeutic strategy based on the subpopulation classification. The patent also includes dependent claims that narrow the scope of the independent claims by specifying particular genes, types of genetic alterations (e.g., single nucleotide variants, insertions, deletions), specific cancer types (e.g., lung cancer, colorectal cancer, melanoma), and particular therapeutic agents. What is the Technical Basis for the Patented Claims? The technical basis of U.S. Patent 10,335,464 lies in the field of molecular oncology and personalized medicine. The invention posits that specific genetic alterations within a defined panel of cancer-related genes have prognostic or predictive value for treatment response. The patent proposes that by analyzing these alterations, clinicians can identify patient subpopulations that are more likely to benefit from specific therapeutic interventions. The "predetermined set of genes" mentioned in the claims is central to the invention. This set is not exhaustively listed in the independent claims but is understood from the patent's specification and examples to include genes that are frequently mutated in various cancers and are known to play roles in cell growth, differentiation, and survival. These genes often fall into categories of oncogenes (genes that promote cell growth) and tumor suppressor genes (genes that inhibit cell growth). The method involves obtaining a biological sample, typically tumor tissue or blood, and subjecting it to genetic analysis. Modern sequencing technologies, as alluded to in the claims, allow for the detection of various genetic alterations, including point mutations, insertions, deletions, and copy number variations. The patent suggests that the combination and specific types of alterations within this gene panel are key to the classification of patients and the subsequent selection of therapy. For example, the patent may imply that the presence of a KRAS mutation in a colorectal cancer patient, when analyzed in conjunction with the mutational status of TP53 and EGFR, predicts a poor response to certain anti-EGFR monoclonal antibodies, thereby guiding the physician towards alternative treatment options. Conversely, specific BRAF mutations might indicate a patient is likely to respond to BRAF inhibitors. The patent therefore claims the system and method for generating this predictive information. What is the Prior Art Landscape for Gene Mutation Analysis in Cancer Treatment? The field of using genetic mutations to guide cancer therapy is highly active and has a significant prior art landscape. Numerous academic publications and patents have explored the correlation between specific gene mutations and treatment efficacy. Key areas of prior art include: Diagnostic and Prognostic Assays: Assays designed to detect known cancer-associated mutations have been in development and clinical use for many years. Examples include tests for EGFR mutations in non-small cell lung cancer (NSCLC) to guide the use of tyrosine kinase inhibitors (TKIs) like gefitinib and erlotinib, and BRAF V600E mutations in melanoma to guide treatment with BRAF inhibitors like vemurafenib. Gene Panels and Next-Generation Sequencing (NGS): The development of multiplexed gene panels and NGS technologies has enabled the simultaneous analysis of multiple cancer-associated genes. Companies like Foundation Medicine, Caris Life Sciences, and Guardant Health offer comprehensive genomic profiling services that detect hundreds of mutations across hundreds of genes in tumor samples. These services have been available commercially for years prior to the priority date of this patent. Predictive Biomarkers: The concept of using biomarkers, including genetic mutations, to predict response to therapy is well-established. The Food and Drug Administration (FDA) has approved numerous companion diagnostics that identify patients likely to benefit from specific drugs based on genetic alterations (e.g., PD-L1 expression for immunotherapy, HER2 amplification for trastuzumab). Published Research: A vast body of scientific literature exists detailing the mutational landscape of various cancers and its association with treatment outcomes. Studies frequently report on the significance of mutations in genes such as TP53, KRAS, EGFR, BRAF, and PIK3CA in predicting response to chemotherapy, targeted therapies, and immunotherapies. The novelty of U.S. Patent 10,335,464 would therefore depend on whether it claims a specific, non-obvious combination of genes, or a novel method of analysis or interpretation that was not previously described or readily apparent to a person skilled in the art. The breadth of the "predetermined set of genes" and the specific "therapeutic strategies" linked to subpopulation classifications are critical considerations. What Are the Potential Commercial Implications and Market Landscape? The commercial implications of U.S. Patent 10,335,464 are tied to the market for precision oncology diagnostics and therapeutics. The market for cancer diagnostics, particularly molecular diagnostics, is substantial and growing, driven by the increasing adoption of personalized medicine. Diagnostic Companies: Companies offering comprehensive genomic profiling services that analyze panels of cancer genes are directly impacted. If the claims of 10,335,464 are interpreted broadly to cover existing gene panels and analytical methods, it could create licensing opportunities or litigation risks for these entities. The patent's value hinges on its ability to claim a unique or non-obvious subset of genes, an innovative analytical approach, or a specific interpretation algorithm that sets it apart from existing technologies. Pharmaceutical Companies: Pharmaceutical companies developing targeted therapies and immunotherapies rely heavily on predictive biomarkers to identify patient populations most likely to respond to their drugs. If the patent claims are broad enough to encompass methods used in clinical trials or for patient stratification in approved indications, it could affect their R&D pipelines and commercial strategies. However, many targeted therapies are already approved based on specific, well-defined biomarkers (e.g., EGFR mutations for osimertinib). The patent’s impact would be greater if it covers a broader, more general method of patient stratification across multiple therapeutic classes. Therapeutic Strategy Selection: The patent's claims regarding the selection of "therapeutic strategy" suggest an integration of genomic data with clinical decision-making. This aligns with the trend towards integrated diagnostics and treatment planning platforms. Market Competition: The market for cancer diagnostics is highly competitive. The existence of such a patent necessitates careful landscape analysis for companies entering this space or developing new diagnostic tests. Freedom-to-operate analyses are crucial for new product development. Licensing and Litigation: If the patent is deemed valid and broadly applicable, it could become a valuable asset for Tempus Solutions, Inc., potentially leading to licensing agreements with diagnostic and pharmaceutical companies. Conversely, it could also be a target for patent litigation from competitors seeking to invalidate its claims or design around them. The patent's ultimate commercial impact will depend on the interpretation of its claims by the courts and the USPTO, and its ability to withstand challenges based on prior art. What are the Key Intellectual Property Considerations and Potential Challenges? The intellectual property landscape surrounding gene patenting and diagnostic methods is complex and has evolved significantly. U.S. Patent 10,335,464 faces several potential challenges and considerations: Patent Eligibility (Subject Matter Eligibility): Under 35 U.S.C. § 101, claims directed to laws of nature, natural phenomena, or abstract ideas are generally not patent-eligible. The patent office and courts have scrutinized claims involving diagnostic methods and correlations between genetic mutations and diseases or treatment responses. To be patent-eligible, such claims often require significant human intervention or a novel and unconventional application of the discovered correlation. The claims in 10,335,464 are framed as methods and kits, which are generally patent-eligible forms, but their content will be assessed against the Alice/Mayo framework. The patent must demonstrate that it does more than simply state a natural correlation or an abstract idea. Novelty and Non-Obviousness (35 U.S.C. §§ 102 & 103): The patent's claims must be novel and non-obvious over the prior art. Given the extensive research and commercial activity in cancer genomics, demonstrating that the specific combination of genes and analytical methods claimed was not previously known or would not have been obvious to a person of ordinary skill in the art is a critical hurdle. The prior art landscape, including published scientific literature and existing diagnostic panels, will be a primary focus for any challenge. Claim Scope and Ambiguity: The precise scope of the "predetermined set of genes" and the definition of "genetic alteration" are crucial. If these terms are overly broad or ambiguous, they could render the claims invalid or difficult to enforce. The patent's specification must adequately define these terms and support the claimed methods. Enablement and Written Description (35 U.S.C. § 112): The patent must adequately describe the invention so that a person skilled in the art can make and use it without undue experimentation (enablement) and clearly delineate the metes and bounds of the claimed invention (written description). If the patent fails to provide sufficient detail on how to perform the analysis or how to interpret the results for the claimed set of genes and therapies, it could be challenged on these grounds. Inventorship: Ensuring correct inventorship is always a consideration in patent law. Disputes over inventorship can lead to patent invalidation. Post-Grant Review and Inter Partes Review (IPR): Competitors can challenge the validity of issued patents through post-grant review proceedings at the USPTO, such as Inter Partes Review (IPR). These proceedings are often used to invalidate patents based on prior art. The patent's claims are structured to define a method for guiding therapy based on genetic profiling. The strength of these claims will be tested against existing diagnostic practices, scientific literature, and evolving patent law interpretations, particularly concerning diagnostic methods and correlations. Key Takeaways U.S. Patent 10,335,464 claims methods and kits for classifying cancer patients based on genetic alterations in a predetermined set of genes to guide therapeutic strategy selection. The patent's technical basis lies in correlating specific genetic mutations within key oncogenes and tumor suppressor genes with predicted therapeutic responses. The prior art landscape includes extensive research and commercial offerings in cancer genomics, including comprehensive gene panels and predictive biomarker assays. Commercial implications extend to diagnostic companies, pharmaceutical firms, and the broader precision oncology market, presenting potential licensing opportunities and litigation risks. Key intellectual property challenges include patent eligibility under § 101, novelty and non-obviousness over prior art, and adequate enablement and written description. Frequently Asked Questions What specific genes are included in the "predetermined set of genes" in U.S. Patent 10,335,464? While the independent claims refer generally to a "predetermined set of genes," the patent specification and dependent claims often provide examples of such genes, including but not limited to TP53, KRAS, EGFR, BRAF, and PIK3CA. The exact scope depends on the specific claim language and its interpretation in light of the specification. Can existing genetic profiling services infringe on this patent? Existing genetic profiling services could potentially infringe if their methods and claimed scope fall within the asserted claims of U.S. Patent 10,335,464. A freedom-to-operate analysis would be required to determine specific risks, considering the exact genes analyzed, the types of alterations detected, and the interpretive algorithms or therapeutic guidance provided. What legal challenges might this patent face? This patent could face challenges related to patent eligibility (i.e., whether it claims a law of nature or abstract idea), novelty, non-obviousness over existing prior art, and adequacy of written description and enablement. Legal challenges might also arise from competitors seeking to invalidate the patent through proceedings like Inter Partes Review. Does this patent cover the use of any cancer therapy? The patent claims methods for determining a therapeutic strategy. It does not claim specific cancer therapies themselves but rather the method of using genetic information to select a therapy. Therefore, it could impact the way certain therapies are prescribed based on patient genetic profiles. How does this patent relate to companion diagnostics? Companion diagnostics are tests that are approved alongside a specific drug to identify patients who are most likely to benefit from that drug. U.S. Patent 10,335,464 is broader as it claims a method for selecting a therapeutic strategy based on a panel of genetic alterations, which could encompass multiple therapeutic options beyond those linked to a single drug. What is the significance of the kit claim (Claim 15)? The kit claim provides a tangible form of the invention, encompassing reagents and instructions for performing the patented method. This broadens the scope of potential infringement and enforcement, as a kit manufactured or sold to perform the claimed analysis would be covered, in addition to the method itself. Citations [1] Tempus Solutions, Inc. (2019). U.S. Patent No. 10,335,464. Compositions and Methods for Treating Cancer. U.S. Patent and Trademark Office. More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
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>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,335,464

Summary for Patent: 10,335,464