Prior art — US Patent 12122824

The US patent 12122824, titled "Anti-TNF antibodies, compositions, and methods for the treatment of active ankylosing spondylitis," has a priority date of January 30, 2017. For a patent to be considered prior art under 35 U.S.C. § 102, its publication or filing date must precede this date.

The core inventive subject matter of US12122824, as described in its "Definitions" section, focuses on:

An isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37.
Compositions and methods utilizing this specific anti-TNF antibody for the safe and effective treatment or prevention of active Psoriatic Arthritis (PsA).
Specific administration protocols, such as IV infusion at a dose of 2 mg/kg at Weeks 0 and 4, then every 8 weeks (q8w) thereafter, leading to defined clinical responses (e.g., ≥65% of patients achieving an ACR20 at week 14 of treatment, with a treatment difference of ≥50% compared to placebo).

The provided full patent text for US12122824B2 does not include a dedicated "References Cited" section with a numbered list of patents. However, it mentions various U.S. patent numbers within its descriptive body, primarily in the context of describing known scientific techniques and technologies. These are treated as the patent citations for the purpose of this analysis.

Based on the searches for these cited patent numbers, the most relevant prior art would be any document that explicitly discloses the specific anti-TNF antibody of US12122824 (defined by SEQ ID NO:36 and SEQ ID NO:37) and its use for treating active Psoriatic Arthritis under the specified conditions. It is important to note that most of the patents cited in US12122824 discuss general methodologies for molecular biology, antibody production, or gene expression, rather than specific antibody sequences or their therapeutic applications. Therefore, these generally serve as background art rather than direct anticipatory prior art under 35 U.S.C. § 102 for the specific claims of US12122824.

Below are the patent citations found within the text of US12122824, along with their details and an assessment of their potential anticipation:

1. US Patent 5,627,052

Full Citation: US5627052A, "Selected lymphocyte antibody method (SLAM)", Wen, Lihua; Alaimo, Joe A.; Knoell, Elizabeth S.; Chang, Michael N., Assignee: Baylor College of Medicine.
Publication/Filing Date: Publication Date: May 6, 1997.
Brief Description: This patent describes a method for generating antibodies from single cells, specifically the "selected lymphocyte antibody method (SLAM)," which involves selecting antibody-producing cells and immortalizing them to produce hybridomas.
Potential Anticipation: This patent describes a method for antibody production. It does not disclose the specific amino acid sequences (SEQ ID NO:36 and SEQ ID NO:37) of the anti-TNF antibody claimed in US12122824, nor its specific use in treating Psoriatic Arthritis. Therefore, it does not anticipate the claims of US12122824 related to the specific antibody, its composition, or its therapeutic application.

2. US Patents by Lonberg et al. (Transgenic Mice)
US12122824 cites several patents by Lonberg et al. concerning transgenic mice capable of producing human antibodies. These include: US5770428, US5569825, US5545806, US5625126, US5625825, US5633425, US5661016, and US5789650.

US5545806A: "Transgenic non-human animals for producing heterologous antibodies", Lonberg, Nils; Kay, Robert M., Assignee: Genpharm International, Inc.
- Publication/Filing Date: Publication Date: August 13, 1996.
- Brief Description: This patent discloses transgenic non-human animals (e.g., mice) engineered to produce heterologous (e.g., human) antibodies. These animals have inactivated endogenous immunoglobulin loci and contain functionally rearranged human immunoglobulin genes.
- Potential Anticipation: This patent describes a system and method for producing human antibodies in transgenic animals. It does not disclose the specific anti-TNF antibody sequences (SEQ ID NO:36 and SEQ ID NO:37) of US12122824, nor their specific therapeutic use for Psoriatic Arthritis. Thus, it serves as general enabling technology for antibody production but does not anticipate the specific claims. The other Lonberg et al. patents in this group relate to similar technologies for generating human antibodies in transgenic animals and would have similar anticipation assessments.

3. US Patents for Transgenic Animals Producing Antibodies in Milk
US12122824 cites a group of patents for providing transgenic animals that produce antibodies in their milk: US5827690, US5849992, US4873316, US5994616, US5565362, and US5304489.

US5849992B2: "Capping machine", Zanini, Gianpietro; Baroni, Marco, Assignee: Azionaria Costruzioni Macchine Automatiche ACMA SpA.
- Publication/Filing Date: Publication Date: June 11, 2013.
- Brief Description: This patent describes a mechanical capping machine for closing containers with screw caps or snap caps.
- Potential Anticipation: This patent is completely unrelated to antibodies or their production in transgenic animals, and thus does not anticipate any claims of US12122824. There appears to be a factual error in the original US12122824 patent text in citing this number for transgenic animals producing antibodies in milk. Due to the literal interpretation rule, this discrepancy is noted.
The remaining patents in this group (US5827690, US4873316, US5994616, US5565362, US5304489) would need individual examination. Assuming they are correctly cited in US12122824 as relating to transgenic animals producing antibodies in milk, they would fall into the category of general methods for antibody production, similar to the Lonberg et al. patents, and would not anticipate the specific antibody sequence or its use for PsA treatment.

4. US Patent 5,130,238 (RNA Mediated Amplification)

Full Citation: US5130238A, "Enhanced nucleic acid amplification process", Malek, Lawrence T.; Schoenwald, David A., Assignee: Cangene Corporation.
Publication/Filing Date: Publication Date: July 14, 1992.
Brief Description: This patent describes an enhanced nucleic acid amplification process, also known as Nucleic Acid Sequence-Based Amplification (NASBA), which is an isothermal method for amplifying RNA.
Potential Anticipation: This patent describes a method for nucleic acid amplification. It does not disclose the specific anti-TNF antibody sequences (SEQ ID NO:36 and SEQ ID NO:37) or their specific therapeutic use in treating Psoriatic Arthritis. Therefore, it does not anticipate the claims of US12122824.

5. US Patents for DHFR Resistance for Eukaryotic Cell Culture
US12122824 cites several patents related to dihydrofolate reductase (DHFR) resistance for eukaryotic cell culture: US4399216, US4634665, US4656134, US4956288, US5149636, and US5179017.

US4399216A: "Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials", Axel, Richard; Wigler, Michael H.; Silverstein, Saul J., Assignee: The Trustees of Columbia University in the City of New York.
- Publication/Filing Date: Publication Date: August 16, 1983.
- Brief Description: This patent describes processes for introducing and expressing foreign DNA in eukaryotic cells, including cotransformation techniques to produce proteinaceous materials. It mentions using selectable markers like the thymidine kinase (tk) gene.
- Potential Anticipation: This patent describes general methods for gene transfer and protein production in eukaryotic cells. While foundational to recombinant DNA technology, it does not disclose the specific anti-TNF antibody or its therapeutic application for PsA, and therefore does not anticipate the claims of US12122824. The other patents in this group would generally relate to similar selectable marker systems for eukaryotic cell culture, serving as enabling technologies rather than anticipatory prior art for the specific invention.

6. US Patents for Glutamine Synthetase (GS) Resistance for Eukaryotic Cell Culture
US12122824 cites patents related to glutamine synthetase (GS) resistance: US5122464, US5770359, and US5827739.

US5122464A: "Method for dominant selection in eucaryotic cells", Bebbington, Christopher R.; Hentschel, Christopher C. G., Assignee: Celltech Ltd.
- Publication/Filing Date: Publication Date: April 7, 1992.
- Brief Description: This patent describes recombinant DNA sequences encoding glutamine synthetase (GS), vectors for these sequences, and their use as dominant selectable markers for gene amplification and to make host cells glutamine independent.
- Potential Anticipation: This patent describes a method for cell selection and gene amplification using the GS system, which is a general tool in recombinant protein production. It does not disclose the specific anti-TNF antibody sequences (SEQ ID NO:36 and SEQ ID NO:37) or their specific use in treating Psoriatic Arthritis. Therefore, it does not anticipate the claims of US12122824.
US5770359A: "Recombinant DNA molecules and use thereof in mammalian cell expression", Bebbington, Christopher R.; Hentschel, Christopher C. G., Assignee: Celltech Ltd.
- Publication/Filing Date: Publication Date: May 5, 1998.
- Brief Description: This patent, a continuation-in-part of US5122464, describes recombinant DNA molecules and methods for achieving high-level expression of foreign genes in mammalian cells, often using the glutamine synthetase (GS) selection system.
- Potential Anticipation: Similar to US5122464A, this is a general method for expressing foreign genes in mammalian cells using GS selection and does not anticipate the specific anti-TNF antibody or its therapeutic use.
US5827739A: "Genes encoding glutamine synthetase and uses for plant improvement", Bidney, Dennis L.; Bowen, Bruce A.; Davis, Mary E.; Du, Qiong; Feng, Peter C.; Jones, Jeffrey W.; Lu, Guihua; Malvar, Thomas; Sidorov, Viktor A.; Spitz, David B.; Wieckert, Patrick, Assignee: Monsanto Technology LLC.
- Publication/Filing Date: Publication Date: October 27, 1998.
- Brief Description: This patent describes recombinant DNA molecules for the expression of proteins, including glutamine synthetase, for use in improving traits in transgenic plants.
- Potential Anticipation: While it concerns glutamine synthetase, its application is focused on plant genetic engineering for crop improvement. It does not disclose the specific anti-TNF antibody sequences (SEQ ID NO:36 and SEQ ID NO:37) or their specific use in treating Psoriatic Arthritis in humans. Therefore, it does not anticipate the claims of US12122824.

7. US Patents for Expressing Nucleic Acids in Host Cells by Manipulating Endogenous DNA
US12122824 cites patents for methods of expressing nucleic acids in host cells by manipulating endogenous DNA: US5580734, US5641670, US5733746, and US5733761.

These patents describe general methods of gene expression and regulation by manipulating endogenous DNA in host cells. Similar to the other methodology patents, they would serve as background art, enabling the production of proteins, but not disclosing the specific anti-TNF antibody (SEQ ID NO:36, 37) or its application in PsA treatment.

8. US Patents for the CMV Promoter
US12122824 cites patents related to the Cytomegalovirus (CMV) promoter: US5168062 and US5385839.

US5168062A: "Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence", Stinski, Mark F., Assignee: University Of Iowa Research Foundation.
- Publication/Filing Date: Publication Date: December 1, 1992.
- Brief Description: This patent describes the cloning of a DNA molecule containing regulatory signals for efficient transcription in human cells, specifically the human cytomegalovirus (HCMV) immediate-early promoter-regulatory region, which enhances gene expression.
- Potential Anticipation: This patent describes a promoter sequence used as a general tool in gene expression. It does not disclose the specific anti-TNF antibody sequences (SEQ ID NO:36 and SEQ ID NO:37) or their specific therapeutic use in treating Psoriatic Arthritis. Therefore, it does not anticipate the claims of US12122824.
US5385839A: "Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter regulatory DNA sequence", Stinski, Mark F., Assignee: University Of Iowa Research Foundation.
- Publication/Filing Date: Publication Date: January 31, 1995.
- Brief Description: As a continuation of US5168062A, this patent similarly describes the cloning and use of the HCMV promoter-regulatory sequence for enhancing gene expression in eukaryotic cells. It also broadly mentions the capability of transformed microorganisms to produce various proteins, including antibodies.
- Potential Anticipation: Similar to US5168062A, this is a general enabling technology for gene expression and does not anticipate the specific anti-TNF antibody or its therapeutic use for PsA.

Unnumbered Citation:

US12122824 mentions "Mullis, et al., U.S. Pat. No." in the context of PCR amplification. Without a specific patent number, this reference cannot be individually searched and assessed. However, the general concept of PCR (Polymerase Chain Reaction) is a widely known molecular biology technique, and many patents by Mullis and others exist on this topic, dating back to the 1980s. These would be considered general enabling prior art for nucleic acid manipulation but would not anticipate the specific anti-TNF antibody or its therapeutic application.

Conclusion on Most Relevant Prior Art:
Based on the analysis of the patents explicitly cited within the US12122824B2 text, none of the identified prior art anticipates the core inventive subject matter of US12122824 under 35 U.S.C. § 102. The cited patents describe general methodologies for genetic engineering, antibody production, cell culture, or gene expression, which are foundational technologies. They do not disclose the specific anti-TNF antibody defined by SEQ ID NO:36 and SEQ ID NO:37, its composition, or its specific use for treating active Psoriatic Arthritis with the outlined administration regimen and clinical outcomes. For these general methods to anticipate a claim, they would need to explicitly disclose every element of that claim, which they do not. They function as background art, demonstrating the state of the art in the broader field rather than directly anticipating the specific invention.